Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Family Intervention for Adolescent Problem Behavior (AKA Project Alliance 2) (PAL-2)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Oregon
ClinicalTrials.gov Identifier:
NCT01490307
First received: August 16, 2011
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Substance Use
Conduct Disorder
Depression
Anxiety
Behavioral: Family Check-Up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Family Intervention for Adolescent Problem Behavior

Resource links provided by NLM:


Further study details as provided by University of Oregon:

Primary Outcome Measures:
  • growth in substance use [ Time Frame: 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. ] [ Designated as safety issue: No ]
    The Student Survey was collected from all youth, regardless of treatment condition, annually across 6th-10th grades. It includes 6 questions about the frequency with which the adolescent used 5 substances in the last month: cigarettes, chewing tobacco or snuff, alcohol (overall quantity and most at one time), marijuana or hashish, and other hard drugs. Growth curve modeling will be used to represent change in substance use across time.

  • growth in antisocial behavior [ Time Frame: 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. ] [ Designated as safety issue: No ]
    The Student Survey was collected from all youth, regardless of treatment condition, annually across 6th-10th grades. It includes youth reports of engagement in antisocial behavior during the past month, measured by averaging across 11 items on a 6-point scale ranging from "never" to "more than 20 times" during the past month. The items included content such as lying to parents, staying out all night without permission, stealing, carrying a weapon, and physical aggression. Growth curve modeling will be used to represent change in antisocial behavior across time.

  • growth in deviant peer involvement [ Time Frame: 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. ] [ Designated as safety issue: No ]
    The Student Survey was collected from all youth, regardless of treatment condition, annually across 6th-10th grades. It includes youth reports of the behavior of the friends with whom they have spent the most time in the past month. Youth are asked how many of these friends have engaged in 11 behaviors in the past month, using a 5-point scale ranging from "none" to "4 or more." The items include content such as selling illegal drugs, carrying a knife or handgun, and getting arrested. Growth curve modeling will be used to represent change in deviant peer involvement across time.


Secondary Outcome Measures:
  • growth in family management skills [ Time Frame: 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. ] [ Designated as safety issue: No ]
    The family assessment was collected from families who received the FCU; it includes caregiver and child assessment packets and parent-child videotaped interactions. Caregiver and child assessments include reports of family management, including parental monitoring and parent-school involvement. Videotaped interactions are evaluated and each family rated on factors such as supervision, listening skills, use of encouragement, and problem solving. Growth curve modeling will be used to represent change in family management skills across time.

  • positive change in family relationship quality [ Time Frame: 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. ] [ Designated as safety issue: No ]
    The family assessment was collected from families who received the FCU; it includes caregiver and child assessment packets and parent-child videotaped interactions. Caregiver and child assessments include reports of positive relationship and family conflict. Videotaped interactions include seven 5-8 minute discussions on family-related matters. These interactions are evaluated and each family rated on positive relationship and family conflict. Growth curve modeling will be used to represent change in family relationship quality across time.


Enrollment: 593
Study Start Date: February 2006
Study Completion Date: March 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FCU offered Behavioral: Family Check-Up
The Family Check-Up starts with a rapport-building session that allows therapists to gauge parents' concerns and motivation for change. This is followed by a thorough assessment of individual family strengths and weaknesses, utilizing parent and child questionnaires and family video observations. Parents then receive feedback on the results of the assessment using motivational interviewing techniques. Attention is focused on parents' and children's readiness to change, as well as the delineation of specific change options. Families may continued to receive tailored intervention services using the Everyday Parenting Curriculum.
Other Names:
  • Adolescent Transitions Project (ATP)
  • Ecological Family Intervention and Treatment (EcoFIT)
No Intervention: No feedback or services offered

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490307

Locations
United States, Oregon
University of Oregon-Child and Family Center
Portland, Oregon, United States, 97232
Sponsors and Collaborators
University of Oregon
Investigators
Principal Investigator: Elizabeth A Stormshak, PhD University of Oregon
Principal Investigator: Thomas J Dishion, PhD University of Oregon
Principal Investigator: Kathryn A Kavanagh, PhD University of Oregon
Study Director: Allison S Caruthers, PhD University of Oregon
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oregon
ClinicalTrials.gov Identifier: NCT01490307     History of Changes
Other Study ID Numbers: R01DA018374, R01DA018374
Study First Received: August 16, 2011
Last Updated: December 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oregon:
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

Additional relevant MeSH terms:
Conduct Disorder
Depression
Depressive Disorder
Attention Deficit and Disruptive Behavior Disorders
Behavioral Symptoms
Mental Disorders
Mental Disorders Diagnosed in Childhood
Mood Disorders

ClinicalTrials.gov processed this record on November 19, 2014