NCT00985595

Brief Summary

The objective of the study is to test the effectiveness, implementation quality, and cost effectiveness of family-based treatment services for adolescent substance abuse delivered in an agency setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

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

January 1, 2006

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

6.2 years

First QC Date

September 25, 2009

Last Update Submit

August 3, 2015

Conditions

Keywords

Adolescentsubstance abuse

Outcome Measures

Primary Outcomes (1)

  • The primary aims of the study are to examine the effectiveness of FBEI versus SAU and to compare the strength of FBEI adherence and outcomes to performance benchmarks set during a previous FBEI efficacy trial.

    3, 6, 12 months after baseline

Secondary Outcomes (1)

  • The secondary aims are to compare cost effectiveness, services utilization, and consumer satisfaction in FBEI versus SAU.

    3, 6, 12 months after baseline

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Adolescents screened for symptoms of substance abuse/dependence, and their families, will participate in the study. Participants will include 260 male and female adolescents who complete the enrollment process, meet eligibility criteria, and consent to be randomized into one of two study conditions. Youth will be referred primarily from two sources: juvenile justice agencies and local schools/community programs. Based on the demographics of adolescents currently participating in partner sites, youth are likely to be predominantly male (69%), Hispanic (68%), and African American (32%). Families are generally low income from disadvantaged neighborhoods, with high rates of family mental health and substance use problems.

You may qualify if:

  • ages 13 and 17,
  • have a caregiver willing to participate in treatment,
  • meet ASAM criteria for outpatient or intensive outpatient substance abuse treatment,
  • not receiving any other behavioral treatment, and
  • have public or private health benefits that meet standard community clinic registration requirements.

You may not qualify if:

  • mental retardation,
  • pervasive developmental disorder,
  • medical or psychiatric illness requiring hospitalization,
  • current psychotic features, or
  • current suicidality (Ideation + Plan + High Intention).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The National Center on Addiction and Substance Abuse at Columbia University

New York, New York, 10017, United States

Location

Related Publications (1)

  • Mattos LA, Schmidt AT, Henderson CE, Hogue A. Therapeutic alliance and treatment outcome in the outpatient treatment of urban adolescents: The role of callous-unemotional traits. Psychotherapy (Chic). 2017 Jun;54(2):136-147. doi: 10.1037/pst0000093. Epub 2016 Nov 10.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Aaron Hogue, Ph.D.

    The National Center on Addiction and Substance Abuse at Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Adolescent and Family Research

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 28, 2009

Study Start

January 1, 2006

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations