N/A
N=322
Prevention of Substance Use in At-Risk Students: A Family-Centered Web Program
Substance Use · Conduct Disorders in Adolescence · Depression · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03060291 ↗Enrolled (actual)
322
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change From Baseline in Youth Effortful Control Across 12 Months (Parent Report) — 3.37; 3.19; 3.34; 3.39 score on a scale — p=.549
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FCU-Online, web/ mobile only (Behavioral); FCU-Online, web/ mobile + coach (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Oregon
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Youth Effortful Control Across 12 Months (Parent Report) |
3.37; 3.19; 3.34; 3.39; 3.36; 3.29 | .549 |
| PRIMARY Change From Baseline in Sense of Parenting Importance Across 12 Months (Parent Report) |
4.51; 4.55; 4.49; 4.48; 4.59; 4.47 | .535 |
| PRIMARY Change From Baseline in Sense of Parenting Confidence Across 12 Months (Parent Report) |
4.16; 4.11; 4.13; 4.23; 4.17; 4.08 | .149 |
| PRIMARY Change From Baseline in Parenting Self-Efficacy Across 12 Months (Parent Report) |
2.85; 2.66; 2.75; 2.80; 2.85; 2.75 | .547 |
| PRIMARY Change From Baseline in Youth Conduct Problems Across 12 Months (Parent Report) |
1.37; 1.44; 1.05; 1.32; 1.30; 1.24 | .236 |
| PRIMARY Change From Baseline in Youth Hyperactivity Across 12 Months (Parent Report) |
3.72; 4.19; 3.45; 3.20; 3.47; 3.31 | .599 |
| PRIMARY Change From Baseline in Youth Emotional Problems Across 12 Months (Parent Report) |
2.56; 2.78; 2.34; 2.36; 2.20; 2.56 | .867 |
Summary
The purpose of this study is to develop and evaluate the effectiveness of a web-based version of the Family Check-up (FCU). The FCU is a school-based family-centered intervention that has been developed over the past 20 years and tested across the United States with diverse populations. It focuses on enhancing parenting skills and family management in early adolescence. The FCU has been shown to be highly effective at reducing adolescent problem behavior, achievement problems, depression, and substance use over an extended period of time.
In the original FCU, parents complete an assessment that evaluates family strengths and challenges. They then receive feedback from a family consultant about how their data compare to other families with children of the same age. As part of this feedback session, the consultant helps motivate parents to make changes at home that will positively impact their child and family overall. Parents and consultants decide together which child behaviors they most want to see change. The consultant then works with parents to enhance relevant parenting and family management skills.
Despite the demonstrated effectiveness of this intervention, few schools have the resources and staffing to implement it without substantial support. It seems, then, that schools would benefit from an online package that requires fewer school resources to implement. The FCU-Online is designed to incorporate the successful components of the original FCU while reducing the burden on schools. And, because it is accessed online, parents can utilize this resource at a time and location convenient to them.
In this study, 300 families will be randomly assigned to one of three conditions: a web/ mobile-only version of the FCU, a web/mobile + coach version, or middle school as usual. Research on mental health interventions delivered over the internet suggests that a coach or "in-person" contact enhances outcomes. However, programs that require no coaching or in-person contact are cheaper and easier for schools to deliver. Therefore, a web/ mobile-only version may allow more schools to deliver the intervention to a greater number of families and children. Thus, investigators will test the relative effectiveness of a coach version versus an online-only version at improving key parenting skills. It is predicted that changes in parenting will lead to reductions in risk behavior, such as problem behavior at school and substance use.
Eligibility Criteria
Inclusion Criteria
- enrollment of child in 6th or 7th grade at one of the 6 participating middle schools;
- caregivers are the parent or legal guardian of the participating youth;
- caregivers have web access at home or are willing to access the web via computers located in the school or public library
Exclusion Criteria
- children with severe developmental disabilities or physical disabilities (e.g., autism, genetic disorders, Down syndrome) will not be eligible to participate.
Data sourced from ClinicalTrials.gov (NCT03060291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.