NCT01490307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
593

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
Last Updated

December 12, 2011

Status Verified

December 1, 2011

Enrollment Period

3.9 years

First QC Date

August 16, 2011

Last Update Submit

December 8, 2011

Conditions

Keywords

parenting interventionFamily Check-UpAnxiety DisordersDepressionDepressive DisorderConduct DisorderMental DisordersBehavioral SymptomsMood DisordersMental Disorders Diagnosed in ChildhoodSubstance-Related Disorders

Outcome Measures

Primary Outcomes (3)

  • growth in substance use

    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.

    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.

  • growth in antisocial behavior

    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.

    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.

  • growth in deviant peer involvement

    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.

    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 (2)

  • growth in family management skills

    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.

  • positive change in family relationship quality

    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.

Study Arms (2)

FCU offered

EXPERIMENTAL
Behavioral: Family Check-Up

No feedback or services offered

NO INTERVENTION

Interventions

Family Check-UpBEHAVIORAL

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.

Also known as: Adolescent Transitions Project (ATP), Ecological Family Intervention and Treatment (EcoFIT)
FCU offered

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon-Child and Family Center

Portland, Oregon, 97232, United States

Location

Related Publications (1)

  • Seidman S, Danzo S, Connell A, Stormshak E. The Family Check-Up and Youth Suicide: Assessing Indirect Effects of Improving Self-Regulation and Reducing Depression in Promoting Long-Term Resilience. Suicide Life Threat Behav. 2025 Jun;55(3):e70029. doi: 10.1111/sltb.70029.

MeSH Terms

Conditions

Substance-Related DisordersConduct DisorderDepressionAnxiety DisordersDepressive DisorderMental DisordersBehavioral SymptomsMood DisordersNeurodevelopmental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersAttention Deficit and Disruptive Behavior DisordersBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Allison S Caruthers, PhD

    University of Oregon

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2011

First Posted

December 12, 2011

Study Start

February 1, 2006

Primary Completion

January 1, 2010

Study Completion

March 1, 2011

Last Updated

December 12, 2011

Record last verified: 2011-12

Locations