Clinical trial NCT01490307: A Family Intervention for Adolescent Problem Behavior (AKA Project Alliance 2)
Official title: A Family Intervention for Adolescent Problem Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Conduct Disorder
Depression
Anxiety
Keywords: parenting intervention
Family Check-Up
Anxiety Disorders
Depression
Depressive Disorder
Conduct Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders Diagnosed in Childhood
Substance-Related Disorders
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-12-12
Enrollment: 593
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this project is to empirically refine and improve a comprehensive family-centered prevention strategy for reducing and preventing adolescent substance use and other problem behaviors. This project builds on 15 years of programmatic research underlying the development of the Family Check-up model (FCU), originally referred to as the Adolescent Transitions Program (ATP; Dishion \& Kavanagh, 2003), but later expanded as a general approach to mental health treatment for children from ages 2 through 17 (Dishion \& Stormshak, 2007). The FCU model is a multilevel, family-centered strategy delivered within the context of a public school setting that comprehensively links universal, selected, and indicated family interventions. Previous research and the investigators' practical experience working in school settings indicate that the intervention strategy needs improvement in 3 critical areas to build on previous significant effects and to enhance the potential for future dissemination and large-scale implementation:(a) improve the feasibility of both the universal level and the indicated level of the intervention by broadening the intervention components and systematically embedding these components into the current behavioral support systems in the schools; (b) address the transition from middle school to high school, with special attention to academic engagement and reduction of deviant peer clustering; and (c) explicitly incorporate principals of successful interventions with families and young adolescents of diverse ethnic groups into both the universal and indicated models. An additional general goal of this study is to develop, test, and refine a set of research-based instruments that facilitate evaluation, training, implementation, and monitoring of intervention fidelity to maximize the potential success of implementation and large-scale dissemination.

Participants include 593 youth and their families recruited from the 6th grade in three public middle schools in Portland, OR. Families were randomly assigned to receive either the FCU intervention model or treatment as usual. Assessments were collected for 5 years through the 10th grade. High school transition planning and intensive intervention efforts occurred in Grades 7-9.

The investigators tested the hypothesis that the FCU intervention will reduce the growth of problem behavior and substance use through the enhancement of family management and parent involvement in school.

Detailed description: Specific aims of the current project are to:

1. Establish a Family Resource Center (FRC) that builds on school-wide behavior management;
2. Extend the intervention model to explicitly address the high school transition;
3. Develop intervention components specifically focused on the cultural enhancement with a broader youth population, and test the efficacy of these interventions for reducing risk and enhancing positive adjustment for youth and their families;
4. Evaluate the preventive impact of family engagement on individual differences in the growth of deviant peer involvement, antisocial behavior, and tobacco, alcohol, and marijuana use during the critical transition to high school; and
5. Develop a training and fidelity model related to change.

Eligibility criteria: Inclusion Criteria:

Parents of all sixth grade students across 2 cohorts at 3 public middle schools were invited to participate in this study.

Primary outcomes:
measure: growth in substance use
timeFrame: 5 time points (6th grade, 7th grade, 8th grade, 9th grade, and 10th grade). Avg time between t1 and t2 was 15.1 mo.; avg time between t2 and t3 was 11.9 mo.; avg time between t3 and t4 was 11.4 mo.; avg time between t4 and t5 was 11.6 mo.
measure: growth in antisocial behavior
timeFrame: 5 time points (6th grade, 7th grade, 8th grade, 9th grade, and 10th grade). Avg time between t1 and t2 was 15.1 mo.; avg time between t2 and t3 was 11.9 mo.; avg time between t3 and t4 was 11.4 mo.; avg time between t4 and t5 was 11.6 mo.
measure: growth in deviant peer involvement
timeFrame: 5 time points (6th grade, 7th grade, 8th grade, 9th grade, and 10th grade). Avg time between t1 and t2 was 15.1 mo.; avg time between t2 and t3 was 11.9 mo.; avg time between t3 and t4 was 11.4 mo.; avg time between t4 and t5 was 11.6 mo.
Secondary outcomes:
measure: growth in family management skills
timeFrame: 3 time points (7th grade, summer after 8th grade, and 10th grade). Average time between t1 and t2 was 15.4 months; average time between t2 and t3 was 17.0 months.
measure: positive change in family relationship quality
timeFrame: 3 time points (7th grade, summer after 8th grade, and 10th grade). Average time between t1 and t2 was 15.4 months; average time between t2 and t3 was 17.0 months.
Other outcomes:
Locations:
city: Portland
country: United States
facility: University of Oregon-Child and Family Center
state: Oregon
Study officials:
affiliation: University of Oregon
name: Elizabeth A Stormshak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oregon
name: Thomas J Dishion, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oregon
name: Kathryn A Kavanagh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oregon
name: Allison S Caruthers, PhD
role: STUDY_DIRECTOR
References: