Trial Outcomes & Findings for Parenting Young Children Study (NCT NCT05180487)
NCT ID: NCT05180487
Last Updated: 2026-01-27
Results Overview
Parents' skill in supporting positive behavior was measured with the "supporting positive behavior" subscale of the Parenting Young Children Questionnaire (PARYC). Scores could range from 7-49; a higher score indicates greater skill in supporting positive behavior.
COMPLETED
NA
356 participants
baseline, 3 months, 6 months, 12 months
2026-01-27
Participant Flow
947 parents inquired about study participation. Some were excluded due to being unresponsive to outreach (n=289), inquiring after recruitment was closed (n=12), not meeting inclusion criteria (n=244), or declining to participate (n=20). 382 parents qualified to participate, and 356 completed the consent process and baseline data collection. Parents who returned baseline surveys (n=356) were randomly assigned to one of two conditions.
Participant milestones
| Measure |
FCU Online + Coach
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
Waitlist Control
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
|---|---|---|
|
Baseline
STARTED
|
180
|
176
|
|
Baseline
COMPLETED
|
180
|
176
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
3-month Follow-up
STARTED
|
169
|
169
|
|
3-month Follow-up
COMPLETED
|
169
|
169
|
|
3-month Follow-up
NOT COMPLETED
|
0
|
0
|
|
6-month Follow-up
STARTED
|
163
|
165
|
|
6-month Follow-up
COMPLETED
|
163
|
165
|
|
6-month Follow-up
NOT COMPLETED
|
0
|
0
|
|
12-month Follow-up
STARTED
|
165
|
162
|
|
12-month Follow-up
COMPLETED
|
165
|
162
|
|
12-month Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
N=355 for this question, rather than N=356, because data is missing for one participant in the FCU Online + Coach condition.
Baseline characteristics by cohort
| Measure |
FCU Online + Coach
n=180 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
Waitlist Control
n=176 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.77 years
STANDARD_DEVIATION 5.64 • n=179 Participants • N=355 for this question, rather than N=356, because data is missing for one participant in the FCU Online + Coach condition.
|
33.59 years
STANDARD_DEVIATION 6.30 • n=176 Participants • N=355 for this question, rather than N=356, because data is missing for one participant in the FCU Online + Coach condition.
|
33.68 years
STANDARD_DEVIATION 5.97 • n=355 Participants • N=355 for this question, rather than N=356, because data is missing for one participant in the FCU Online + Coach condition.
|
|
Sex: Female, Male
Female
|
169 Participants
n=180 Participants • N=354 for this question, rather than N=356, because two participants in the waitlist control condition chose not to respond to this demographic question.
|
161 Participants
n=174 Participants • N=354 for this question, rather than N=356, because two participants in the waitlist control condition chose not to respond to this demographic question.
|
330 Participants
n=354 Participants • N=354 for this question, rather than N=356, because two participants in the waitlist control condition chose not to respond to this demographic question.
|
|
Sex: Female, Male
Male
|
11 Participants
n=180 Participants • N=354 for this question, rather than N=356, because two participants in the waitlist control condition chose not to respond to this demographic question.
|
13 Participants
n=174 Participants • N=354 for this question, rather than N=356, because two participants in the waitlist control condition chose not to respond to this demographic question.
|
24 Participants
n=354 Participants • N=354 for this question, rather than N=356, because two participants in the waitlist control condition chose not to respond to this demographic question.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=180 Participants
|
38 Participants
n=176 Participants
|
75 Participants
n=356 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
140 Participants
n=180 Participants
|
135 Participants
n=176 Participants
|
275 Participants
n=356 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=180 Participants
|
3 Participants
n=176 Participants
|
6 Participants
n=356 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=180 Participants
|
3 Participants
n=176 Participants
|
6 Participants
n=356 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=180 Participants
|
2 Participants
n=176 Participants
|
6 Participants
n=356 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=180 Participants
|
1 Participants
n=176 Participants
|
3 Participants
n=356 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=180 Participants
|
5 Participants
n=176 Participants
|
6 Participants
n=356 Participants
|
|
Race (NIH/OMB)
White
|
136 Participants
n=180 Participants
|
134 Participants
n=176 Participants
|
270 Participants
n=356 Participants
|
|
Race (NIH/OMB)
More than one race
|
33 Participants
n=180 Participants
|
30 Participants
n=176 Participants
|
63 Participants
n=356 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=180 Participants
|
1 Participants
n=176 Participants
|
2 Participants
n=356 Participants
|
|
Region of Enrollment
United States
|
180 participants
n=180 Participants
|
176 participants
n=176 Participants
|
356 participants
n=356 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves).
Parents' skill in supporting positive behavior was measured with the "supporting positive behavior" subscale of the Parenting Young Children Questionnaire (PARYC). Scores could range from 7-49; a higher score indicates greater skill in supporting positive behavior.
Outcome measures
| Measure |
Waitlist Control
n=171 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=176 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parenting Skills: Supporting Positive Behavior
12-month follow up
|
37.71 score on a scale
Standard Deviation 6.37
|
39.30 score on a scale
Standard Deviation 5.74
|
|
Change From Baseline in Parenting Skills: Supporting Positive Behavior
baseline
|
37.43 score on a scale
Standard Deviation 6.54
|
37.35 score on a scale
Standard Deviation 5.61
|
|
Change From Baseline in Parenting Skills: Supporting Positive Behavior
3-month follow up
|
37.49 score on a scale
Standard Deviation 6.49
|
38.51 score on a scale
Standard Deviation 5.33
|
|
Change From Baseline in Parenting Skills: Supporting Positive Behavior
6-month follow up
|
37.13 score on a scale
Standard Deviation 6.06
|
39.01 score on a scale
Standard Deviation 5.59
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves).
Parents' skill in setting limits was measured with the "setting limits" subscale of the Parenting Young Children Questionnaire (PARYC). Scores could range from 7-49; a higher score indicates greater skill in setting limits.
Outcome measures
| Measure |
Waitlist Control
n=171 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=177 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parenting Skills: Setting Limits
6-month follow up
|
36.43 score on a scale
Standard Deviation 6.52
|
38.68 score on a scale
Standard Deviation 7.07
|
|
Change From Baseline in Parenting Skills: Setting Limits
12-month follow up
|
36.75 score on a scale
Standard Deviation 6.63
|
39.34 score on a scale
Standard Deviation 6.51
|
|
Change From Baseline in Parenting Skills: Setting Limits
baseline
|
35.04 score on a scale
Standard Deviation 6.70
|
35.40 score on a scale
Standard Deviation 6.13
|
|
Change From Baseline in Parenting Skills: Setting Limits
3-month follow up
|
36.35 score on a scale
Standard Deviation 5.84
|
38.72 score on a scale
Standard Deviation 5.60
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves).
Parents' skill in proactive parenting was measured with the "proactive parenting" subscale of the Parenting Young Children Questionnaire (PARYC). Scores could range from 7-49; a higher score indicates greater skill in proactive parenting.
Outcome measures
| Measure |
Waitlist Control
n=171 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=177 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parenting Skills: Proactive Parenting
baseline
|
35.49 score on a scale
Standard Deviation 7.64
|
36.45 score on a scale
Standard Deviation 6.95
|
|
Change From Baseline in Parenting Skills: Proactive Parenting
3-month follow up
|
36.68 score on a scale
Standard Deviation 6.82
|
40.04 score on a scale
Standard Deviation 5.54
|
|
Change From Baseline in Parenting Skills: Proactive Parenting
6-month follow up
|
37.57 score on a scale
Standard Deviation 7.24
|
40.04 score on a scale
Standard Deviation 6.60
|
|
Change From Baseline in Parenting Skills: Proactive Parenting
12-month follow up
|
37.69 score on a scale
Standard Deviation 6.95
|
39.84 score on a scale
Standard Deviation 6.76
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves).
Parents' confidence in their parenting skills was measured with the Behavioral Self-Efficacy subscale (PAREFF) of the Parenting Tasks Checklist. Scores could range from 1-5; a higher score indicates greater parent confidence.
Outcome measures
| Measure |
Waitlist Control
n=166 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=174 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parenting Confidence
baseline
|
3.73 score on a scale
Standard Deviation 0.70
|
3.74 score on a scale
Standard Deviation 0.72
|
|
Change From Baseline in Parenting Confidence
3-month follow up
|
3.78 score on a scale
Standard Deviation 0.68
|
4.06 score on a scale
Standard Deviation 0.57
|
|
Change From Baseline in Parenting Confidence
6-month follow up
|
3.78 score on a scale
Standard Deviation 0.66
|
4.11 score on a scale
Standard Deviation 0.61
|
|
Change From Baseline in Parenting Confidence
12-month follow up
|
3.91 score on a scale
Standard Deviation 0.68
|
4.14 score on a scale
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves).
Parent substance use was measured with the Opioid and Other Substance Use Involvement measure from the HEAL Prevention Cooperative Common Constructs. This measure assesses participants' use of alcohol, cannabis, prescription opioids, illegally manufactured opioids, and stimulants. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance. Parents who responded "no" did not receive additional questions about that substance. Parents who indicated prior alcohol use were asked: "During the past 30 days, how many days did you drink alcohol?" Responses could range from 0-30 days. Higher scores indicate more frequent use of alcohol.
Outcome measures
| Measure |
Waitlist Control
n=162 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=169 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parent Alcohol Use
baseline
|
3.05 days
Standard Deviation 5.22
|
2.88 days
Standard Deviation 5.43
|
|
Change From Baseline in Parent Alcohol Use
3-month follow up
|
2.85 days
Standard Deviation 4.98
|
2.38 days
Standard Deviation 4.63
|
|
Change From Baseline in Parent Alcohol Use
6-month follow up
|
2.93 days
Standard Deviation 5.61
|
2.43 days
Standard Deviation 4.62
|
|
Change From Baseline in Parent Alcohol Use
12-month follow up
|
2.41 days
Standard Deviation 4.37
|
1.88 days
Standard Deviation 3.32
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves).
Parent substance use was measured with the Opioid and Other Substance Use Involvement measure from the HEAL Prevention Cooperative Common Constructs. This measure assesses participants' use of alcohol, cannabis, prescription opioids, illegally manufactured opioids, and stimulants. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance; parents who responded "no" did not. The following header was included at the beginning of the section about marijuana use: "The next questions are about marijuana. Marijuana is also called pot, weed, or cannabis. These questions DO NOT include CBD only." Parents with prior marijuana use were asked: "During the past 30 days, how many days did you use marijuana?" Responses could range from 0-30 days. Higher scores indicate more frequent use of marijuana.
Outcome measures
| Measure |
Waitlist Control
n=137 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=133 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parent Marijuana Use
12-month follow up
|
4.55 days
Standard Deviation 9.71
|
4.43 days
Standard Deviation 9.63
|
|
Change From Baseline in Parent Marijuana Use
baseline
|
5.09 days
Standard Deviation 9.98
|
4.58 days
Standard Deviation 9.78
|
|
Change From Baseline in Parent Marijuana Use
3-month follow up
|
4.33 days
Standard Deviation 9.38
|
5.02 days
Standard Deviation 10.40
|
|
Change From Baseline in Parent Marijuana Use
6-month follow up
|
4.58 days
Standard Deviation 9.52
|
4.32 days
Standard Deviation 9.64
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves).
Parent substance use was measured with the Opioid and Other Substance Use Involvement measure from the HEAL Prevention Cooperative. For each substance, parents were asked if they had ever used it. Parents who responded "yes" received additional questions; parents who responded "no" did not. A header in the section about use of prescription opioids read: "This next item asks about using prescription opioids for pain relief or treatment...in any way a doctor or medical provider did not tell you to use them. This includes: * Using without a prescription of your own (for example, someone else's medicine) * Using more or for longer than you were told to take it * Using for reasons other than pain (such as to get high, to sleep, or for anxiety)" Parents with prior prescription opioid misuse were asked: "During the past 30 days, how many days did you use a prescription opioid?" Responses could range from 0-30 days. Higher scores indicate more frequent use of prescription opioids.
Outcome measures
| Measure |
Waitlist Control
n=53 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=51 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parent Prescription Opioid Use
baseline
|
4.98 days
Standard Deviation 10.65
|
4.29 days
Standard Deviation 10.38
|
|
Change From Baseline in Parent Prescription Opioid Use
3-month follow up
|
3.37 days
Standard Deviation 8.96
|
2.00 days
Standard Deviation 6.95
|
|
Change From Baseline in Parent Prescription Opioid Use
6-month follow up
|
4.59 days
Standard Deviation 10.71
|
3.00 days
Standard Deviation 9.12
|
|
Change From Baseline in Parent Prescription Opioid Use
12-month follow up
|
2.30 days
Standard Deviation 7.99
|
1.14 days
Standard Deviation 5.06
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves).
Parent substance use was measured with the Opioid and Other Substance Use Involvement measure from the HEAL Prevention Cooperative Common Constructs. This measure assesses participants' use of alcohol, cannabis, prescription opioids, illegally manufactured opioids, and stimulants. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance; parents who responded "no" did not. The following header was included at the beginning of the section about illegally manufactured opioids: "The next questions ask about manufactured opioids including heroin (also called black tar, poppy, or smack) and Fentanyl." Parents with prior use of illegally manufactured opioids were asked: "During the past 30 days, how many days did you use heroin?" Responses could range from 0-30 days. Higher scores indicate more frequent use of heroin.
Outcome measures
| Measure |
Waitlist Control
n=26 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=24 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parent Use of Illegally Manufactured Opioids
baseline
|
0.00 days
Standard Deviation 0.00
|
1.25 days
Standard Deviation 6.12
|
|
Change From Baseline in Parent Use of Illegally Manufactured Opioids
3-month follow up
|
1.13 days
Standard Deviation 5.42
|
1.43 days
Standard Deviation 6.55
|
|
Change From Baseline in Parent Use of Illegally Manufactured Opioids
6-month follow up
|
0.00 days
Standard Deviation 0.00
|
0.21 days
Standard Deviation 0.92
|
|
Change From Baseline in Parent Use of Illegally Manufactured Opioids
12-month follow up
|
1.50 days
Standard Deviation 6.71
|
1.11 days
Standard Deviation 4.82
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves).
Parent substance use was measured with the Opioid and Other Substance Use Involvement measure from the HEAL Prevention Cooperative Common Constructs. A series of questions were asked about each substance of interest, starting with a question assessing if the parent had ever used the substance. Parents who responded "yes" received additional questions about that substance; parents who responded "no" did not. The following header was included at the beginning of the section about use of stimulants: "The next questions ask about stimulants. Some examples of stimulants include: Adderall, Concerta, Cylert, Provigil, Ritalin or Dexedrine, speed, amphetamine, methamphetamine, uppers, bennies, pep pills, crystal, crank." Parents with prior stimulant use were asked: "During the past 30 days, how many days did you use stimulants?" Responses could range from 0-30 days. Higher scores indicate more frequent use of stimulants.
Outcome measures
| Measure |
Waitlist Control
n=63 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=60 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parent Stimulant Use
baseline
|
5.70 days
Standard Deviation 11.47
|
4.95 days
Standard Deviation 10.48
|
|
Change From Baseline in Parent Stimulant Use
3-month follow up
|
3.48 days
Standard Deviation 9.31
|
4.31 days
Standard Deviation 10.09
|
|
Change From Baseline in Parent Stimulant Use
6-month follow up
|
4.18 days
Standard Deviation 10.17
|
4.71 days
Standard Deviation 10.50
|
|
Change From Baseline in Parent Stimulant Use
12-month follow up
|
2.57 days
Standard Deviation 7.76
|
6.0 days
Standard Deviation 11.42
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). Because no families were ever lost to follow-up or withdrew from the study, all families who participated at baseline were invited to participate at each follow-up wave. Thus, there are a few families who participated at 12-month follow-up who did not participate at an earlier follow-up wave.
Parental depression was measured with the Patient Health Questionnaire-9 (PHQ-9). Scores could range from 0-27; a higher score indicates greater depression.
Outcome measures
| Measure |
Waitlist Control
n=175 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=178 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parental Depression
Baseline
|
7.20 score on a scale
Standard Deviation 5.74
|
8.14 score on a scale
Standard Deviation 5.94
|
|
Change From Baseline in Parental Depression
3-month follow-up
|
6.63 score on a scale
Standard Deviation 5.45
|
6.38 score on a scale
Standard Deviation 5.58
|
|
Change From Baseline in Parental Depression
6-month follow-up
|
6.33 score on a scale
Standard Deviation 5.50
|
6.17 score on a scale
Standard Deviation 5.42
|
|
Change From Baseline in Parental Depression
12-month follow-up
|
6.06 score on a scale
Standard Deviation 5.02
|
6.10 score on a scale
Standard Deviation 5.01
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). Because no families were ever lost to follow-up or withdrew from the study, all families who participated at baseline were invited to participate at each follow-up wave. Thus, there are a few families who participated at 12-month follow-up who did not participate at an earlier follow-up wave.
Parental anxiety was measured with the General Anxiety Disorder-7 (GAD-7). Scores could range from 0-21; a higher score indicates greater anxiety.
Outcome measures
| Measure |
Waitlist Control
n=175 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=177 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parental Anxiety
6-month follow up
|
6.54 score on a scale
Standard Deviation 5.63
|
6.21 score on a scale
Standard Deviation 5.31
|
|
Change From Baseline in Parental Anxiety
12-month follow-up
|
6.03 score on a scale
Standard Deviation 5.19
|
6.37 score on a scale
Standard Deviation 5.27
|
|
Change From Baseline in Parental Anxiety
Baseline
|
7.41 score on a scale
Standard Deviation 5.26
|
7.99 score on a scale
Standard Deviation 5.73
|
|
Change From Baseline in Parental Anxiety
3-month follow up
|
6.90 score on a scale
Standard Deviation 5.47
|
6.63 score on a scale
Standard Deviation 5.31
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPopulation: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning surveys at follow-up waves). Because no families were ever lost to follow-up or withdrew from the study, all families who participated at baseline were invited to participate at each follow-up wave. Thus, there are a few families who participated at 12-month follow-up who did not participate at an earlier follow-up wave.
Parental stress was measured with the Perceived Stress Scale. Scores could range from 0-56; a higher score indicates high perceived stress.
Outcome measures
| Measure |
Waitlist Control
n=175 Participants
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website after completing four waves of data collection (baseline, 3-mo, 6-mo, and 12-mo follow-up).
|
FCU Online + Coach
n=178 Participants
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching will focus on Wellness and Self-Care, Parenting and Substance Use, Positive Parenting, Proactive Parenting, and Supervision and Limit Setting.
Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be provided.
|
|---|---|---|
|
Change From Baseline in Parental Stress
Baseline
|
26.60 score on a scale
Standard Deviation 7.84
|
26.97 score on a scale
Standard Deviation 8.80
|
|
Change From Baseline in Parental Stress
3-month follow up
|
25.56 score on a scale
Standard Deviation 7.86
|
24.53 score on a scale
Standard Deviation 8.38
|
|
Change From Baseline in Parental Stress
6-month follow up
|
25.37 score on a scale
Standard Deviation 8.67
|
24.18 score on a scale
Standard Deviation 8.62
|
|
Change From Baseline in Parental Stress
12-month follow up
|
25.15 score on a scale
Standard Deviation 8.22
|
24.88 score on a scale
Standard Deviation 8.16
|
Adverse Events
FCU Online + Coach
Waitlist Control
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