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



Status:Active, not recruiting
Conditions:Anxiety, Anxiety, Depression, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:10/17/2018
Start Date:February 21, 2017
End Date:September 30, 2019

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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.

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.

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.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
?
mi
from
Portland, OR
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