Trial Outcomes & Findings for Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms (NCT NCT04045132)
NCT ID: NCT04045132
Last Updated: 2023-12-27
Results Overview
The Parent Child Early Relational Assessment (PCERA) is a validated 65-item videotape assessment designed to measure the quality of affect and behavior in parent-infant interactions. The PCERA uses ratings that are based on observations of 5-minute videotaped interactions with parent-infant dyads engaged in free play. The PCERA has been shown to possess good interrater reliability, internal consistency, discriminant and concurrent validity, and sensitivity to change. The PCERA contains 8 subscales of which 3 parenting subscales will be the focus: 1) Parental Positive Affective Involvement and Verbalization, 2) Parental Negative Affect and Behavior, and 3) Parental Intrusiveness, Insensitivity, and Inconsistency. Each individual subscale is scored between 0-5, with higher scores indicating more responsive parenting. A subscale score of 1-2 indicates an area of concern, a score of 3 indicates some concern, and a score of 4-5 indicates an area of strength.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Baseline and 3 Months
Results posted on
2023-12-27
Participant Flow
From December 2019 to March 2020, recruitment took place over the phone and enrollment was completed on site at the Roberts Center for Pediatric Research at the Children's Hospital of Philadelphia. Due to the COVID-19 pandemic, there was a recruitment pause from March-June 2020. As of June 12th, 2020, the study was approved by the IRB to enroll participants to the study virtually, and remaining recruitment and enrollment activities were completed virtually.
If a participant was enrolled to the study but did not complete the videotaped baseline Parent Child Early Relational Assessment before the start of the intervention, regardless of the group they were randomized to, they were withdrawn from the study.
Participant milestones
| Measure |
MoodGym Alone (Control)
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
38
|
|
Overall Study
COMPLETED
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
MoodGym Alone (Control)
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
Baseline Characteristics
Participants who completed a Baseline Parent Child Early Relational Assessment (PCERA) videotape measure were included in the overall analysis. At Baseline, 73 (36 control and 37 intervention) of the 75 total enrolled participants completed a PCERA videotape measure. .
Baseline characteristics by cohort
| Measure |
MoodGym Alone (Control)
n=37 Participants
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=38 Participants
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 4.8 • n=37 Participants
|
29.8 years
STANDARD_DEVIATION 5.6 • n=38 Participants
|
29.2 years
STANDARD_DEVIATION 5.2 • n=75 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=37 Participants
|
38 Participants
n=38 Participants
|
75 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=37 Participants
|
2 Participants
n=38 Participants
|
3 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=37 Participants
|
36 Participants
n=38 Participants
|
72 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=75 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 participants
n=37 Participants
|
0 participants
n=38 Participants
|
0 participants
n=75 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=37 Participants
|
0 participants
n=38 Participants
|
0 participants
n=75 Participants
|
|
Race/Ethnicity, Customized
Black
|
28 participants
n=37 Participants
|
24 participants
n=38 Participants
|
52 participants
n=75 Participants
|
|
Race/Ethnicity, Customized
>1 Race/Other
|
1 participants
n=37 Participants
|
3 participants
n=38 Participants
|
4 participants
n=75 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=37 Participants
|
0 participants
n=38 Participants
|
1 participants
n=75 Participants
|
|
Race/Ethnicity, Customized
White
|
7 participants
n=37 Participants
|
11 participants
n=38 Participants
|
18 participants
n=75 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=37 Participants
|
38 participants
n=38 Participants
|
75 participants
n=75 Participants
|
|
The Parent Child Early Relational Assessment (PCERA)
PCERA Factor 1 (Baseline)- Parental Positive Affective Involvement and Verbalization
|
3.0 score on a scale
STANDARD_DEVIATION 0.6 • n=36 Participants • Participants who completed a Baseline Parent Child Early Relational Assessment (PCERA) videotape measure were included in the overall analysis. At Baseline, 73 (36 control and 37 intervention) of the 75 total enrolled participants completed a PCERA videotape measure. .
|
3.2 score on a scale
STANDARD_DEVIATION 0.6 • n=37 Participants • Participants who completed a Baseline Parent Child Early Relational Assessment (PCERA) videotape measure were included in the overall analysis. At Baseline, 73 (36 control and 37 intervention) of the 75 total enrolled participants completed a PCERA videotape measure. .
|
3.1 score on a scale
STANDARD_DEVIATION 0.6 • n=73 Participants • Participants who completed a Baseline Parent Child Early Relational Assessment (PCERA) videotape measure were included in the overall analysis. At Baseline, 73 (36 control and 37 intervention) of the 75 total enrolled participants completed a PCERA videotape measure. .
|
|
The Parent Child Early Relational Assessment (PCERA)
PCERA Factor 2 (Baseline)- Parental Negative Affect and Behavior
|
4.1 score on a scale
STANDARD_DEVIATION 0.7 • n=37 Participants • Participants who completed a Baseline Parent Child Early Relational Assessment (PCERA) videotape measure were included in the overall analysis. At Baseline, 73 (36 control and 37 intervention) of the 75 total enrolled participants completed a PCERA videotape measure. .
|
4.0 score on a scale
STANDARD_DEVIATION 0.8 • n=38 Participants • Participants who completed a Baseline Parent Child Early Relational Assessment (PCERA) videotape measure were included in the overall analysis. At Baseline, 73 (36 control and 37 intervention) of the 75 total enrolled participants completed a PCERA videotape measure. .
|
4.1 score on a scale
STANDARD_DEVIATION 0.8 • n=75 Participants • Participants who completed a Baseline Parent Child Early Relational Assessment (PCERA) videotape measure were included in the overall analysis. At Baseline, 73 (36 control and 37 intervention) of the 75 total enrolled participants completed a PCERA videotape measure. .
|
|
The Parent Child Early Relational Assessment (PCERA)
PCERA Factor 3 (Baseline)- Parental Intrusiveness, Insensitivity, and Inconsistency
|
3.1 score on a scale
STANDARD_DEVIATION 0.4 • n=37 Participants • Participants who completed a Baseline Parent Child Early Relational Assessment (PCERA) videotape measure were included in the overall analysis. At Baseline, 73 (36 control and 37 intervention) of the 75 total enrolled participants completed a PCERA videotape measure. .
|
3.1 score on a scale
STANDARD_DEVIATION 0.7 • n=38 Participants • Participants who completed a Baseline Parent Child Early Relational Assessment (PCERA) videotape measure were included in the overall analysis. At Baseline, 73 (36 control and 37 intervention) of the 75 total enrolled participants completed a PCERA videotape measure. .
|
3.1 score on a scale
STANDARD_DEVIATION 0.6 • n=75 Participants • Participants who completed a Baseline Parent Child Early Relational Assessment (PCERA) videotape measure were included in the overall analysis. At Baseline, 73 (36 control and 37 intervention) of the 75 total enrolled participants completed a PCERA videotape measure. .
|
PRIMARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Participants who completed both a Baseline and 3-month follow-up Parent Child Early Relational Assessment (PCERA) videotape measure were included in the overall analysis. At Baseline, 73 (36 control and 37 intervention) of the 75 total enrolled participants completed a PCERA videotape measure, and 66 (34 control and 32 intervention) of the 75 total enrolled participants completed a PCERA videotape measure at 3-month follow-up.
The Parent Child Early Relational Assessment (PCERA) is a validated 65-item videotape assessment designed to measure the quality of affect and behavior in parent-infant interactions. The PCERA uses ratings that are based on observations of 5-minute videotaped interactions with parent-infant dyads engaged in free play. The PCERA has been shown to possess good interrater reliability, internal consistency, discriminant and concurrent validity, and sensitivity to change. The PCERA contains 8 subscales of which 3 parenting subscales will be the focus: 1) Parental Positive Affective Involvement and Verbalization, 2) Parental Negative Affect and Behavior, and 3) Parental Intrusiveness, Insensitivity, and Inconsistency. Each individual subscale is scored between 0-5, with higher scores indicating more responsive parenting. A subscale score of 1-2 indicates an area of concern, a score of 3 indicates some concern, and a score of 4-5 indicates an area of strength.
Outcome measures
| Measure |
MoodGym Alone (Control)
n=36 Participants
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=37 Participants
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
The Parent Child Early Relational Assessment (PCERA)
PCERA Factor 1 (Baseline)- Parental Positive Affective Involvement and Verbalization
|
3.0 score on a scale
Standard Deviation 0.6
|
3.2 score on a scale
Standard Deviation 0.6
|
|
The Parent Child Early Relational Assessment (PCERA)
PCERA Factor 1 (3-month follow-up)- Parental Positive Affective Involvement and Verbalization
|
3.3 score on a scale
Standard Deviation 0.5
|
3.3 score on a scale
Standard Deviation 0.6
|
|
The Parent Child Early Relational Assessment (PCERA)
PCERA Factor 2 (Baseline)- Parental Negative Affect and Behavior
|
4.1 score on a scale
Standard Deviation 0.7
|
4.0 score on a scale
Standard Deviation 0.8
|
|
The Parent Child Early Relational Assessment (PCERA)
PCERA Factor 2 (3-month follow-up)- Parental Negative Affect and Behavior
|
4.3 score on a scale
Standard Deviation 0.6
|
4.2 score on a scale
Standard Deviation 0.8
|
|
The Parent Child Early Relational Assessment (PCERA)
PCERA Factor 3 (Baseline)- Parental Intrusiveness, Insensitivity, and Inconsistency
|
3.1 score on a scale
Standard Deviation 0.4
|
3.1 score on a scale
Standard Deviation 0.7
|
|
The Parent Child Early Relational Assessment (PCERA)
PCERA Factor 3 (3-month follow-up)- Parental Intrusiveness, Insensitivity, and Inconsistency
|
3.5 score on a scale
Standard Deviation 0.5
|
3.4 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, 1-month, 2-month, 3-monthPopulation: Participants who completed the Edinburgh Postnatal Depression Scale (EPDS) measure at each time point were included in the analysis. Over the 3-month time frame there were several participants who were lost to follow-up and did not complete the subsequent EPDS measures. This is the reason for the drop in number of participants analyzed between groups over the 3-month period.
The Edinburgh Postnatal Depression Scale (EPDS) is a validated 10-item self-report measure of depressive symptoms with strong evidence for reliability, validity, and utility in varying populations. It has been used extensively in mental health research and provides cutpoints to determine the severity of depressive symptoms. It includes a question on suicidal thoughts and wishes (#10) that will be used to monitor for suicidality. The total score (range: 0-30) will be used with scores of 10 or higher representing minor or moderate depression and scores of 20 or greater representing severe depression.These outcomes will assess changes in EPDS from baseline to 3 months.
Outcome measures
| Measure |
MoodGym Alone (Control)
n=37 Participants
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=37 Participants
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
The Edinburgh Postnatal Depression Scale (EPDS)
EPDS Baseline
|
15.2 score on a scale
Interval 7.0 to 25.0
|
14.3 score on a scale
Interval 7.0 to 20.0
|
|
The Edinburgh Postnatal Depression Scale (EPDS)
EPDS 1-month follow-up
|
12.6 score on a scale
Interval 4.0 to 23.0
|
9.7 score on a scale
Interval 3.0 to 19.0
|
|
The Edinburgh Postnatal Depression Scale (EPDS)
EPDS 2-month follow-up
|
11.7 score on a scale
Interval 5.0 to 28.0
|
9.7 score on a scale
Interval 2.0 to 19.0
|
|
The Edinburgh Postnatal Depression Scale (EPDS)
EPDS 3-month follow-up
|
10.1 score on a scale
Interval 0.0 to 19.0
|
9.0 score on a scale
Interval 1.0 to 22.0
|
SECONDARY outcome
Timeframe: Baseline and 3-monthsPopulation: Participants who completed the Beck Depression Inventory (BDI-II) measure at each time point were included in the analysis. At baseline there was one participant, of the 75 total enrolled, who did not complete any baseline measures, including the BDI-II. Over the 3-month time frame there were several participants who were lost to follow-up and did not complete the BDI-II measure. This is the reason for the drop in number of participants analyzed between groups over the 3-month period.
The Beck Depression Inventory (BDI-II) is a 21-item self-report tool that measures the severity of depression and includes two subscales: cognitive and somatic. It has been well validated, and widely used, with scores 14-19 indicating mild depression, 20-28 moderate depression, and 29-63 severe depression. The total score (range: 0-63) will be used, with higher scores indicating higher levels of depression. These outcomes will assess changes in BDI-II from baseline to 3 months.
Outcome measures
| Measure |
MoodGym Alone (Control)
n=37 Participants
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=37 Participants
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
The Beck Depression Inventory (BDI-II)
BDI-II Baseline
|
23.6 score on a scale
Interval 13.0 to 46.0
|
22.4 score on a scale
Interval 5.0 to 41.0
|
|
The Beck Depression Inventory (BDI-II)
BDI-II 3-month follow-up
|
14.6 score on a scale
Interval 0.0 to 42.0
|
14.3 score on a scale
Interval 1.0 to 40.0
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Participants who completed the Parenting Sense of Competence Scale (PSOC) measure at each time point were included in the analysis. At baseline there was one participant, of the 75 total enrolled, who did not complete any baseline measures, including the PSOC. Over the 3-month time frame there were several participants who were lost to follow-up and did not complete the PSOC measure. This is the reason for the drop in number of participants analyzed between groups over the 3-month period.
The Parenting Sense of Competence Scale (PSOC) is a validated 17-item self-report measure of parenting self-esteem and competence and consists of two factors: satisfaction and efficacy. Response categories are on a 6-point likert-scale from strongly disagree to strongly agree. The total score (range: 17-102), which includes the sum of the two factors, will be used. A higher score indicates a higher parenting sense of competency. There are no average scores or 'cut-off's' for this tool. These outcomes will assess changes in PSOC from baseline to 3 months.
Outcome measures
| Measure |
MoodGym Alone (Control)
n=37 Participants
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=37 Participants
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
The Parenting Sense of Competence Scale (PSOC)
PSOC Baseline
|
63.2 score on a scale
Interval 48.0 to 80.0
|
63.9 score on a scale
Interval 40.0 to 87.0
|
|
The Parenting Sense of Competence Scale (PSOC)
PSOC 3-month follow-up
|
71.3 score on a scale
Interval 55.0 to 93.0
|
71.1 score on a scale
Interval 51.0 to 88.0
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Participants who completed the Parenting Stress Index-Short Form (PSI-SF) measure at each time point were included in the analysis. At baseline there was one participant, of the 75 total enrolled, who did not complete any baseline measures, including the PSI-SF. Over the 3-month time frame there were several participants who were lost to follow-up and did not complete the PSI-SF measure. This is the reason for the drop in number of participants analyzed between groups over the 3-month period.
The Parenting Stress Index-Short Form (PSI-SF) is a validated 36-item scale that measures parenting stress. The PSI-SF is a direct derivative of the full-length test (PSI) and it has been shown to have excellent internal consistency and to be positively associated with maternal psychological distress. Scores on the PSI-SF correlate well with the full-length PSI. It yields a Total Stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The total score (range: 36-180) will be used, with higher scores indicating higher levels of stress.These outcomes will assess changes in PSI-SF from baseline to 3 months.
Outcome measures
| Measure |
MoodGym Alone (Control)
n=37 Participants
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=37 Participants
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
The Parenting Stress Index-Short Form (PSI-SF)
PSI-SF Baseline
|
89.2 score on a scale
Interval 58.0 to 134.0
|
85.4 score on a scale
Interval 48.0 to 115.0
|
|
The Parenting Stress Index-Short Form (PSI-SF)
PSI-SF 3-month follow-up
|
75.5 score on a scale
Interval 36.0 to 130.0
|
73.6 score on a scale
Interval 38.0 to 108.0
|
SECONDARY outcome
Timeframe: 1-month, 2-month, 3-monthPopulation: Participants who completed the National Comorbidity Survey (NCS) measure at each time point were included in the analysis. Over the 3-month time frame there were several participants who were lost to follow-up and did not complete the NCSmeasure. This is the reason for the drop in number of participants analyzed between groups over the 3-month period.
The National Comorbidity Survey (NCS) provides data on mental health treatment in the United States. We will include a question from the NCS on prior mental health services use in the past month: "In the past month, did you receive treatment for problems with your emotions or nerves, or your use of alcohol or drugs?" We will consider mental health service use to have occurred in the past month if a mother responds "Yes" to this question. The results indicate the number of participants from each group who received mental health services/treatment at each time point. Additionally, if a mother responds "Yes" to the initial NCS item, a follow-up question will be asked to determine the specific types of services that were accessed: "If yes, what type of treatment did you receive?"
Outcome measures
| Measure |
MoodGym Alone (Control)
n=37 Participants
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=37 Participants
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
The National Comorbidity Survey (NCS)
NCS 1-month follow-up
|
10 Participants
|
7 Participants
|
|
The National Comorbidity Survey (NCS)
NCS 2-month follow-up
|
12 Participants
|
8 Participants
|
|
The National Comorbidity Survey (NCS)
NCS 3-month follow-up
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed a Baseline Multi-dimensional Scale of Perceived Social Support (MSPSS) measure were included in the overall analysis. At Baseline, 74 (37 control and 37 intervention) of the 75 total enrolled participants completed the MSPSS measure.
The Multi-dimensional Scale of Perceived Social Support (MSPSS) is a 12-item scale that assesses perceived social support from family, friends, and a significant other. Response categories are on a 7-point likert-scale from 1=very strongly disagree to 7=very strongly agree. The total score will be used (range: 12-84).
Outcome measures
| Measure |
MoodGym Alone (Control)
n=37 Participants
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=37 Participants
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
Multi-dimensional Scale of Perceived Social Support (MSPSS)
|
52.9 score on a scale
Interval 12.0 to 84.0
|
58.0 score on a scale
Interval 18.0 to 84.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants in the Parenting Program + MoodGym (Intervention arm), only. At the 3-month time point, there were several participants who had been lost to follow-up and did not complete the TFI-8 measure. This is the reason for the drop in number of participants.
The TFI-8 is a validated 8-item scale that is used to measure cohesion and is continuous process monitoring for therapy groups. Scores on the TFI-8 correlate well with the full TFI. The total score (range: 8-56) will be used, with higher scores indicating greater cohesion within the group. The TFI-8 will be administered at the 3-month visit to the intervention group, only.
Outcome measures
| Measure |
MoodGym Alone (Control)
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=34 Participants
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
Therapeutic Factors Inventory (TFI-8)
|
—
|
40.5 score on a scale
Interval 18.0 to 56.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants in the Parenting Program + MoodGym (Intervention arm), only. At the 3-month time point, there were several participants who had been lost to follow-up and did not complete the Acceptability Survey measure. This is the reason for the drop in number of participants.
The Acceptability survey is a 10-item scaled with 3 additional open ended questions that will be used to assess feasibility of the parenting program. The total score (range: 9-45) will be used and the open ended questions will be qualitatively analyzed to help inform the acceptability scores. Higher scores on the acceptability survey indicate greater satisfaction and feasibility of the parenting program. The acceptability survey will be administered at the 3-month visit to the intervention, only.
Outcome measures
| Measure |
MoodGym Alone (Control)
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=34 Participants
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
Acceptability Survey
|
—
|
34.8 score on a scale
Interval 17.0 to 45.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who completed a 3-month MoodGym Acceptability Survey measure were included in the overall analysis. At the 3-month time point, there were several participants who had been lost to follow-up and did not complete the MoodGym Acceptability Survey measure. This is the reason for the drop in number of participants.
The MoodGym Acceptability survey will be used to assess feasibility of the online depression treatment program, MoodGym. The survey includes two qualitative open-ended questions and an additional question that asks, "It is \_\_\_\_\_\_\_\_\_\_\_ that I will use MoodGym compared to going to a health care provider for depression treatment." The response is a 5-point likert-scale from "Much More Likely" to "Much Less Likely". The open ended questions will be qualitatively analyzed to help inform the acceptability scores. The MoodGym Acceptability survey will be administered at the 3-month visit to both the intervention and control group.
Outcome measures
| Measure |
MoodGym Alone (Control)
n=32 Participants
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=31 Participants
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
MoodGym Acceptability Survey
Much More Likely
|
7 Participants
|
6 Participants
|
|
MoodGym Acceptability Survey
More Likely
|
9 Participants
|
6 Participants
|
|
MoodGym Acceptability Survey
No Difference
|
7 Participants
|
11 Participants
|
|
MoodGym Acceptability Survey
Less Likely
|
3 Participants
|
4 Participants
|
|
MoodGym Acceptability Survey
Much Less Likely
|
6 Participants
|
4 Participants
|
Adverse Events
MoodGym Alone (Control)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Parenting Program + MoodGym (Intervention)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MoodGym Alone (Control)
n=37 participants at risk
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=38 participants at risk；n=37 participants at risk
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization-Breach of Confidentiality
|
5.4%
2/37 • Number of events 2 • Adverse event data collected over the span of the 2-year study period
The Children's Hospital of Philadelphia Institutional Review Board (IRB) defines a Serious Adverse Event (SAE) as follows: Serious Adverse Event (SAE)- an adverse event that: * results in death; * is life-threatening; * prolongs or results in hospitalization; * results in a persistent or significant disability; * causes a congenital anomaly or birth defect; or * is a medically significant event that jeopardizes the subject's health
|
0.00%
0/37 • Adverse event data collected over the span of the 2-year study period
The Children's Hospital of Philadelphia Institutional Review Board (IRB) defines a Serious Adverse Event (SAE) as follows: Serious Adverse Event (SAE)- an adverse event that: * results in death; * is life-threatening; * prolongs or results in hospitalization; * results in a persistent or significant disability; * causes a congenital anomaly or birth defect; or * is a medically significant event that jeopardizes the subject's health
|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/37 • Adverse event data collected over the span of the 2-year study period
The Children's Hospital of Philadelphia Institutional Review Board (IRB) defines a Serious Adverse Event (SAE) as follows: Serious Adverse Event (SAE)- an adverse event that: * results in death; * is life-threatening; * prolongs or results in hospitalization; * results in a persistent or significant disability; * causes a congenital anomaly or birth defect; or * is a medically significant event that jeopardizes the subject's health
|
5.4%
2/37 • Number of events 2 • Adverse event data collected over the span of the 2-year study period
The Children's Hospital of Philadelphia Institutional Review Board (IRB) defines a Serious Adverse Event (SAE) as follows: Serious Adverse Event (SAE)- an adverse event that: * results in death; * is life-threatening; * prolongs or results in hospitalization; * results in a persistent or significant disability; * causes a congenital anomaly or birth defect; or * is a medically significant event that jeopardizes the subject's health
|
Other adverse events
| Measure |
MoodGym Alone (Control)
n=37 participants at risk
The MoodGym program is an evidence-based online cognitive behavioral treatment program that has been shown to be effective at reducing depression symptoms in a meta-analysis of 11 trials (g=0.36, 95% CI 0.17-0.56). Moodgym contains five modules with interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files that can be completed online without therapist interaction.
MoodGym: Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
|
Parenting Program + MoodGym (Intervention)
n=38 participants at risk；n=37 participants at risk
The social media-based parenting program consists of 8 weekly sessions with the following topics: depression psychoeducation and behavioral activation, infant temperament, play, feeding, safety, sleep, parent-child interactions, and shared book reading. Participants in the experimental arm will also be enrolled in the online depression treatment program, MoodGym.
Social Media-Based Parenting Program: Participants in the intervention group will be enrolled in Facebook secret user groups. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage).
MoodGym: Participants in the control and intervention groups will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention.
|
|---|---|---|
|
Psychiatric disorders
Protocol Deviation- Incorrect Version of Informed Consent
|
2.7%
1/37 • Number of events 1 • Adverse event data collected over the span of the 2-year study period
The Children's Hospital of Philadelphia Institutional Review Board (IRB) defines a Serious Adverse Event (SAE) as follows: Serious Adverse Event (SAE)- an adverse event that: * results in death; * is life-threatening; * prolongs or results in hospitalization; * results in a persistent or significant disability; * causes a congenital anomaly or birth defect; or * is a medically significant event that jeopardizes the subject's health
|
5.3%
2/38 • Number of events 2 • Adverse event data collected over the span of the 2-year study period
The Children's Hospital of Philadelphia Institutional Review Board (IRB) defines a Serious Adverse Event (SAE) as follows: Serious Adverse Event (SAE)- an adverse event that: * results in death; * is life-threatening; * prolongs or results in hospitalization; * results in a persistent or significant disability; * causes a congenital anomaly or birth defect; or * is a medically significant event that jeopardizes the subject's health
|
|
Psychiatric disorders
Protocol Deviation- Unstamped Version of Informed Consent
|
16.2%
6/37 • Number of events 6 • Adverse event data collected over the span of the 2-year study period
The Children's Hospital of Philadelphia Institutional Review Board (IRB) defines a Serious Adverse Event (SAE) as follows: Serious Adverse Event (SAE)- an adverse event that: * results in death; * is life-threatening; * prolongs or results in hospitalization; * results in a persistent or significant disability; * causes a congenital anomaly or birth defect; or * is a medically significant event that jeopardizes the subject's health
|
15.8%
6/38 • Number of events 6 • Adverse event data collected over the span of the 2-year study period
The Children's Hospital of Philadelphia Institutional Review Board (IRB) defines a Serious Adverse Event (SAE) as follows: Serious Adverse Event (SAE)- an adverse event that: * results in death; * is life-threatening; * prolongs or results in hospitalization; * results in a persistent or significant disability; * causes a congenital anomaly or birth defect; or * is a medically significant event that jeopardizes the subject's health
|
Additional Information
Dr. James Guevara
The Children's Hospital of Philadelphia
Phone: 2155901130
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place