Prevention of Substance Use in At-Risk Students: A Family-Centered Web Program

NCT ID: NCT03060291

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2019-09-30

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.

Conditions

Substance Use; Conduct Disorders in Adolescence; Depression; Anxiety

Keywords

Family Check-up

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Web/ Mobile-only

Participants will complete the FCU online independently, without the help of a coach.

Group Type: EXPERIMENTAL

FCU-Online, web/ mobile only

Intervention Type: BEHAVIORAL

Participants will be invited to complete the FCU via the FCU-Online website. They will complete an assessment, receive computer-generated feedback, and access to skills units designed to teach parents the importance of using specific parenting skills, provide practice opportunities to try these skills, and tools to track their use of these parenting skills and any associated changes in child behavior.

Web/mobile + coach

Participants will complete the FCU online and will be contacted by a family coach. The coach will conduct motivational interviewing and provide support to parents via phone. Participants in this condition will have contact with a coach at least 2 times.

Group Type: ACTIVE_COMPARATOR

FCU-Online, web/ mobile + coach

Intervention Type: BEHAVIORAL

Participants will be invited to complete the FCU via the FCU-Online website. They will complete an assessment, receive computer-generated feedback, and access to skills units designed to teach parents the importance of using specific parenting skills, provide practice opportunities to try these skills, and tools to track their use of these parenting skills and any associated changes in child behavior. Participants will also have access to a "family coach" who will motivate parents to enhance parenting skills and provide support while they are learning to use these skills.

Wait list control

Participants in this condition will receive "middle school as usual", meaning that they will continue to receive whatever services are normally provided by the middle school during the year of their participation in the study. Once their research participation is completed (i.e., after they complete their final follow-up survey), participants in this condition will be offered the opportunity to use the FCU-Online website if they wish, without the support of a coach. No additional data will be collected.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FCU-Online, web/ mobile only

Participants will be invited to complete the FCU via the FCU-Online website. They will complete an assessment, receive computer-generated feedback, and access to skills units designed to teach parents the importance of using specific parenting skills, provide practice opportunities to try these skills, and tools to track their use of these parenting skills and any associated changes in child behavior.

Intervention Type: BEHAVIORAL

FCU-Online, web/ mobile + coach

Participants will be invited to complete the FCU via the FCU-Online website. They will complete an assessment, receive computer-generated feedback, and access to skills units designed to teach parents the importance of using specific parenting skills, provide practice opportunities to try these skills, and tools to track their use of these parenting skills and any associated changes in child behavior. Participants will also have access to a "family coach" who will motivate parents to enhance parenting skills and provide support while they are learning to use these skills.

Intervention Type: BEHAVIORAL

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Oregon

OTHER

Sponsor Role: lead

Responsible Party

Beth Stormshak

Knight Chair and Professor, College of Education, and Director, Prevention Science Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Stormshak, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oregon

John Seeley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oregon

Locations

University of Oregon

Portland, Oregon, United States

Countries

United States

References

Stormshak E, Connell A, Mauricio AM, McLaughlin M, Caruthers A. Digital Health Delivery of Parenting Skills to Improve Conduct Problems in Middle School Youth Across Two Distinct Randomized Trials. Prev Sci. 2025 May;26(4):582-591. doi: 10.1007/s11121-024-01750-2. Epub 2024 Nov 18.

Reference Type: DERIVED

PMID: 39556238 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30021712 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DA037628

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA037628

Identifier Type: NIH

Identifier Source: org_study_id

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