Trial Outcomes & Findings for Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth (NCT NCT03709472)
NCT ID: NCT03709472
Last Updated: 2024-11-05
Results Overview
The Columbia yields information on suicide ideation and Ideation with Intent. Youth were categorized as having or not having ideation and having or not having intent to suicide (yes/no). Endorsing any of these items as "yes" is a worse outcome. The number listed below is the number of participants that said "yes" to experiencing suicidal ideation in the last month.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
172 participants
Primary outcome timeframe
Baseline, 4 months post baseline, 12 months post baseline
Results posted on
2024-11-05
Participant Flow
For each family, an adolescent and a caregiver were consented and participated in the study. 42 adolescents and their caregivers were randomized in each arm and received intervention. However, for the outcome measures section, only the adolescent's data was collected and reported for the study.
Four families declined to participate after enrollment (consent and intake assessment) and before randomization.
Participant milestones
| Measure |
Computer Assisted CIFFTA
CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session
Computer Assisted CIFFTA: This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.
|
Behavioral: Traditional Face-to-face Treatment-no Technology
Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community
Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
|
|---|---|---|
|
Baseline
STARTED
|
84
|
84
|
|
Baseline
Adolescent
|
42
|
42
|
|
Baseline
Caregiver
|
42
|
42
|
|
Baseline
COMPLETED
|
84
|
84
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
4 Month Assessment (Post Treatment)
STARTED
|
84
|
84
|
|
4 Month Assessment (Post Treatment)
Adolescent
|
38
|
27
|
|
4 Month Assessment (Post Treatment)
Caregiver
|
38
|
27
|
|
4 Month Assessment (Post Treatment)
COMPLETED
|
76
|
54
|
|
4 Month Assessment (Post Treatment)
NOT COMPLETED
|
8
|
30
|
|
Assessment (12-month Post Baseline)
STARTED
|
84
|
84
|
|
Assessment (12-month Post Baseline)
Adolescent
|
36
|
19
|
|
Assessment (12-month Post Baseline)
Caregiver
|
36
|
19
|
|
Assessment (12-month Post Baseline)
COMPLETED
|
72
|
38
|
|
Assessment (12-month Post Baseline)
NOT COMPLETED
|
12
|
46
|
Reasons for withdrawal
| Measure |
Computer Assisted CIFFTA
CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session
Computer Assisted CIFFTA: This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.
|
Behavioral: Traditional Face-to-face Treatment-no Technology
Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community
Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
|
|---|---|---|
|
4 Month Assessment (Post Treatment)
Lost to Follow-up
|
8
|
30
|
|
Assessment (12-month Post Baseline)
Lost to Follow-up
|
12
|
46
|
Baseline Characteristics
Adolescents and Caregivers reported separately for this analysis
Baseline characteristics by cohort
| Measure |
Computer Assisted CIFFTA
n=84 Participants
CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session
Computer Assisted CIFFTA: This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.
|
Behavioral: Traditional Face-to-face Treatment-no Technology
n=84 Participants
Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community
Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
42 Participants
n=84 Participants
|
42 Participants
n=84 Participants
|
84 Participants
n=168 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=84 Participants
|
42 Participants
n=84 Participants
|
84 Participants
n=168 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=84 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=168 Participants
|
|
Sex/Gender, Customized
Adolescent · Female
|
38 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
34 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
72 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Sex/Gender, Customized
Adolescent · Male
|
4 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
6 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
10 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Sex/Gender, Customized
Adolescent · Intersex
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
1 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
1 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Sex/Gender, Customized
Adolescent · Unknown
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
1 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
1 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Sex/Gender, Customized
Caregiver · Female
|
39 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
37 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
76 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Sex/Gender, Customized
Caregiver · Male
|
3 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
5 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
8 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Sex/Gender, Customized
Caregiver · Intersex
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Sex/Gender, Customized
Caregiver · Unknown
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Ethnicity (NIH/OMB)
Adolescent · Hispanic or Latino
|
36 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
37 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
73 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Ethnicity (NIH/OMB)
Adolescent · Not Hispanic or Latino
|
3 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
2 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
5 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Ethnicity (NIH/OMB)
Adolescent · Unknown or Not Reported
|
3 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
3 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
6 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Ethnicity (NIH/OMB)
Caregiver · Hispanic or Latino
|
38 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
40 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
78 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Ethnicity (NIH/OMB)
Caregiver · Not Hispanic or Latino
|
4 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
2 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
6 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Ethnicity (NIH/OMB)
Caregiver · Unknown or Not Reported
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Adolescent · American Indian or Alaska Native
|
4 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
1 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
5 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Adolescent · Asian
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
1 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
1 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Adolescent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Adolescent · Black or African American
|
1 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
3 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
4 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Adolescent · White
|
25 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
26 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
51 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Adolescent · More than one race
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Adolescent · Unknown or Not Reported
|
12 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
11 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
23 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Caregiver · American Indian or Alaska Native
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Caregiver · Asian
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Caregiver · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Caregiver · Black or African American
|
2 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
2 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Caregiver · White
|
8 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
7 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
15 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Caregiver · More than one race
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
0 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
|
Race (NIH/OMB)
Caregiver · Unknown or Not Reported
|
32 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
35 Participants
n=42 Participants • Adolescents and Caregivers reported separately for this analysis
|
67 Participants
n=84 Participants • Adolescents and Caregivers reported separately for this analysis
|
PRIMARY outcome
Timeframe: Baseline, 4 months post baseline, 12 months post baselinePopulation: Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse". This interferes with scoring.
The Columbia yields information on suicide ideation and Ideation with Intent. Youth were categorized as having or not having ideation and having or not having intent to suicide (yes/no). Endorsing any of these items as "yes" is a worse outcome. The number listed below is the number of participants that said "yes" to experiencing suicidal ideation in the last month.
Outcome measures
| Measure |
Computer Assisted CIFFTA
n=38 Participants
CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session
Computer Assisted CIFFTA: This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.
|
Behavioral: Traditional Face-to-face Treatment-no Technology
n=27 Participants
Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community
Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
|
|---|---|---|
|
Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation
Baseline
|
20 Participants
|
13 Participants
|
|
Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation
4-month assessment (post-treatment)
|
16 Participants
|
8 Participants
|
|
Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation
12-month assessment (12 months post baseline)
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 4 months post baseline, 12 months post baselinePopulation: Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse" and this interferes with scoring.
The Deliberate Self-harm Inventory Youth Version (DSHI-Y) documents self-harm behavior. The data collected focused on the number of participants who reported "yes" to having engaged in self-harm in the past 30 days.
Outcome measures
| Measure |
Computer Assisted CIFFTA
n=38 Participants
CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session
Computer Assisted CIFFTA: This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.
|
Behavioral: Traditional Face-to-face Treatment-no Technology
n=27 Participants
Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community
Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
|
|---|---|---|
|
Number of Participants Who Reported Self-harm Behavior
Baseline
|
25 Participants
|
18 Participants
|
|
Number of Participants Who Reported Self-harm Behavior
4- month assessment (post treatment assessment)
|
14 Participants
|
11 Participants
|
|
Number of Participants Who Reported Self-harm Behavior
12 months assessment (12 months post baseline)
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 4 months post baseline, 12 months post baselinePopulation: Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse". This interferes with scoring.
Difficulties with Emotion Regulation Scale -Short form (DERS), is designed to assess emotional dysregulation using a 5-point Likert Scale. The total score is calculated from the sum of all items, with higher scores indicating greater problems with emotion regulation. Total summed scores can range from 18 - 90 but investigators report that average item score (1-5) rather than the sum so that is more easily interpretable in the 5 point Likert Scale.
Outcome measures
| Measure |
Computer Assisted CIFFTA
n=38 Participants
CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session
Computer Assisted CIFFTA: This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.
|
Behavioral: Traditional Face-to-face Treatment-no Technology
n=27 Participants
Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community
Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
|
|---|---|---|
|
Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS)
Baseline
|
3.1 score on a scale
Standard Deviation .75
|
3.2 score on a scale
Standard Deviation .78
|
|
Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS)
4-month assessment (post-treatment)
|
2.8 score on a scale
Standard Deviation .59
|
2.9 score on a scale
Standard Deviation .78
|
|
Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS)
12-month assessment post baseline
|
2.6 score on a scale
Standard Deviation .76
|
2.8 score on a scale
Standard Deviation .71
|
SECONDARY outcome
Timeframe: Baseline, 4 months post baseline, 12 months post baselinePopulation: Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse". This interferes with scoring.
The PHQ-9 incorporates the DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. Depression Severity: 0 - none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Outcome measures
| Measure |
Computer Assisted CIFFTA
n=38 Participants
CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session
Computer Assisted CIFFTA: This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.
|
Behavioral: Traditional Face-to-face Treatment-no Technology
n=27 Participants
Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community
Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
|
|---|---|---|
|
The Patient Health Questionnaire
Baseline
|
13.9 score on a scale
Standard Deviation 6.3
|
14.9 score on a scale
Standard Deviation 7.0
|
|
The Patient Health Questionnaire
4-month assessment (post treatment)
|
10.8 score on a scale
Standard Deviation 5.8
|
11.6 score on a scale
Standard Deviation 7.7
|
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The Patient Health Questionnaire
12-month assessment (12 months post baseline)
|
8.9 score on a scale
Standard Deviation 6.7
|
10.9 score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Baseline, 4 months post baseline, 12 months post baselinePopulation: Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse". This interferes with scoring.
The Family Connectedness (FC) scale includes seven items assessing communication and the relationship between parents and youth. A composite score was obtained. Two items measured communication and five items measured connectedness. The five Items were scored on a 1-10 scale and summed to a total connectedness score. Minimum score = 5 and Maximum score = 50. Higher scores mean better connections.
Outcome measures
| Measure |
Computer Assisted CIFFTA
n=32 Participants
CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session
Computer Assisted CIFFTA: This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.
|
Behavioral: Traditional Face-to-face Treatment-no Technology
n=23 Participants
Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community
Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
|
|---|---|---|
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Family Connectedness
Baseline
|
32.1 score on a scale
Standard Deviation 9.3
|
28.4 score on a scale
Standard Deviation 10.5
|
|
Family Connectedness
4-month assessment (post treatment)
|
33.4 score on a scale
Standard Deviation 8.8
|
31.4 score on a scale
Standard Deviation 10.6
|
|
Family Connectedness
12-month assessment (12 months post baseline)
|
32.1 score on a scale
Standard Deviation 11.3
|
30.2 score on a scale
Standard Deviation 9.5
|
Adverse Events
Computer Assisted CIFFTA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral: Traditional Face-to-face Treatment-no Technology
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place