Clinical trial NCT03060291: Prevention of Substance Use in At-Risk Students: A Family-Centered Web Program
Official title: Prevention of Substance Use in At-Risk Students: A Family-Centered Web Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Conduct Disorders in Adolescence
Depression
Anxiety
Keywords: Family Check-up
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-02-23
Enrollment: 322
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three conditions: a web/mobile-only condition, a web/mobile + coach condition, or a wait list control group who will receive the web/mobile-only treatment one year after enrolling in the study.
Primary purpose: PREVENTION

Brief 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.

Detailed description: School-based, family-centered interventions for reducing substance use in adolescence have been shown to be highly effective and result in reductions in problem behavior, achievement problems, depression, and substance use over time. Although these interventions have been shown to be effective in efficacy trials across the United States, few schools have the resources to implement these interventions without substantial support. Barriers such as low staffing, poorly trained staff, and limited resources prevent the successful uptake of family-centered interventions in schools, yet most school systems are supportive of enhancing family-school partnerships. Because school systems lack the necessary infrastructure and resources to deliver such an intervention, they would benefit from an online package that is evidence based and accessible to parents. However, few family-centered, web-based interventions for substance use prevention exist on the Internet, and few if any are derived from empirically based programs.

To address this gap, project investigators are developing and will be testing the efficacy of an online version of the Family Check-Up (FCU) for schools that parents can use either at the school or at home. The FCU is a school-based, model-driven intervention that has been developed during the past 20 years and has been iteratively revised on the basis of multiple intervention trials with diverse populations. This study is building upon the investigators' successful program of research by developing and testing the efficacy of The FCU-Online. It is designed to incorporate the successful components of the original FCU, such as a strengths-based assessment that is norm referenced, feedback using motivational interviewing, and follow-up modules that focus on enhancing parenting skills and family management in early adolescence. This research is designed to randomly assign 300 families to receive middle school as usual, the FCU-Online web/mobile only, or the FCU-Online web/mobile+coach version. Research on the delivery of mental health interventions via the Internet suggests that a coach or "in person" contact enhances outcomes; however, programs that require no coaching or in-person contact may have a larger public health impact. A coach version of the intervention will be compared with an online-only version that requires no staffing at schools. Project investigators will test the efficacy of this online version with respect to changing key parenting constructs, such as positive parenting and parental monitoring. It is predicted that changes in parenting will lead to reductions in risk behavior, such as problem behavior at school and substance use. This research will significantly contribute to researchers' understanding of effective interventions for adolescents that reduce risk behavior and substance use during the transition to high school, and it can significantly contribute to the overall uptake and dissemination of family-centered interventions in schools.

Specific aims of this study are as follows:

Aim 1: Design and evaluate a web-based FCU intervention for at-risk families of early adolescents (ages 11-14) that is guided by feedback from focus groups and targets known risk factors of later substance use. The program will feature online assessment and feedback to caretakers delivered via either phone or Internet. An intervention website application and mobile messaging will support delivery of program modules and help motivate and facilitate tracking of activities. Examples will be presented to potential users, including parents and school personnel, to assess feasibility and usability. A 6-month pilot study will test all recruitment, assessment, and intervention procedures.

Aim 2: Examine the efficacy of the FCU-Online intervention by conducting a randomized, controlled trial of 300 at-risk middle school youths. Research suggests that a live coach enhances outcomes associated with web-based interventions; however, a web-based intervention that requires no coaching can be widely disseminated and has greater potential for a large public health impact. The investigators propose to examine outcomes associated with a web/mobile+coach version and a web/mobile-only version of the FCU. Families will be randomly assigned to the FCU-Online intervention (100 web/mobile+coach, 100 web/mobile only) or middle school as usual (n = 100).

Aim 2.1. Evaluate main effects of both versions of the FCU-Online, including academic achievement, behavioral control, family cohesiveness, and delayed onset of substance use.

Aim 2.2. Test a developmental, mediational model in which parenting skills and behavior mediate changes in youth behavior over time. It is expected that families who receive the FCU will show reductions in growth of youths' risk behavior, compared with the control group. Reductions will be mediated by positive changes in parenting behaviors and parenting skill development.

Aim 2.3. Examine moderators, including gender, ethnicity, and socioeconomic status, and model intervention effects by testing moderators over time. The investigators will assess the feasibility of the FCU as an Internet-delivered intervention in middle schools, the extent to which participants engage in the intervention and complete the program, satisfaction with the program, and effects of the FCU on improved parenting skills, positive youth adjustment, and reductions in youth problem behavior over 2 years.

Aim 2.4. Examine factors related to successful uptake and implementation of the intervention in schools. The public health impact of an Internet intervention is diminished if uptake of the intervention is poor. To understand factors related to implementation in schools, school personnel will be trained at the end of the project in delivery of the FCU-Online intervention. The investigators will assess feasibility, usage, coach fidelity, and uptake through engagement data collected via the website. Data from teachers and school administrators will be collected to examine factors that promote implementation in schools and that further researchers' understanding of how this intervention will be applied in a real-world setting.

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.

Primary outcomes:
measure: Change From Baseline in Youth Effortful Control Across 12 Months (Parent Report)
timeFrame: baseline; 3 months; 6 months; 1 year
measure: Change From Baseline in Sense of Parenting Importance Across 12 Months (Parent Report)
timeFrame: baseline; 3 months; 6 months; 1 year
measure: Change From Baseline in Sense of Parenting Confidence Across 12 Months (Parent Report)
timeFrame: baseline; 3 months; 6 months; 1 year
measure: Change From Baseline in Parenting Self-Efficacy Across 12 Months (Parent Report)
timeFrame: baseline; 3 months; 6 months; 1 year
measure: Change From Baseline in Youth Conduct Problems Across 12 Months (Parent Report)
timeFrame: baseline; 3 months; 6 months; 1 year
measure: Change From Baseline in Youth Hyperactivity Across 12 Months (Parent Report)
timeFrame: baseline; 3 months; 6 months; 1 year
measure: Change From Baseline in Youth Emotional Problems Across 12 Months (Parent Report)
timeFrame: baseline; 3 months; 6 months; 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Elizabeth Stormshak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oregon
name: John Seeley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danaher BG, Seeley JR, Stormshak EA, Tyler MS, Caruthers AS, Moore KJ, Cardenas L. The Family Check-Up Online Program for Parents of Middle School Students: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Jul 18;7(7):e11106. doi: 10.2196/11106.