NCT00680381

Brief Summary

The purpose of this study is to test different treatments to reduce relapse for drug-abusing adolescents who have completed family therapy. Adolescents receive 12 weeks of family therapy, designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use. Then they are randomly assigned to receive one of three eight-week follow-up treatments: phone calls from a project therapist, group therapy, or a customized schedule of therapist visits with the adolescent, the adolescent's family and teachers, coaches, probation officers and others who can help the adolescent reach or maintain abstinence. Families are assessed using questionnaires and interviews before, during and after treatment, to provide information about family functioning, the adolescent's drug use, the adolescent's peers and other factors that may contribute to treatment success or failure. Adolescents also provide urine specimens for drug screening at assessment visits. Study investigators expect the study will show that a functional family environment and insulating adolescents from the influence of peers who use drugs will help prevent relapse for adolescents who have received family therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

10.5 years

First QC Date

May 16, 2008

Last Update Submit

August 4, 2014

Conditions

Keywords

adolescent substance abuse

Outcome Measures

Primary Outcomes (1)

  • Drug use levels for adolescents who have received family therapy and one of the three aftercare regimens

    pretx and 6 wks, 4 , 7 and 12 mos. post initial therapy session

Study Arms (3)

1

ACTIVE COMPARATOR

Following 12 weeks of Functional Family Therapy (FFT), semi-weekly therapist phone calls for eight weeks.

Behavioral: MTI, Minimal Transitional Intervention

2

ACTIVE COMPARATOR

Following 12 weeks of FFT, weekly one-hour group therapy for eight weeks

Behavioral: GTI, Group Transitional Intervention

3

ACTIVE COMPARATOR

Following 12 weeks of FFT, an eight-week, customized series of therapist visits with the adolescent, family, teachers, coaches and others who can support the adolescent's reduced level of drug use.

Behavioral: STI, Systems Transitions Intervention

Interventions

Following 12 weeks of Functional Family Therapy (FFT), semi-weekly phone calls from a therapist for eight weeks.

1

Following 12 weeks of FFT, weekly one-hour sessions of group therapy for eight weeks.

2

Following 12 weeks of FFT, an individualized eight-week series of therapist meetings with the adolescent, family, police, teachers, coaches and others who can support the adolescent's reduced drug use.

3

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • At least one parent, step-parent, or surrogate parent willing to participate in the study
  • to 18 years if age
  • meets DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence
  • Lives in the Albuquerque metropolitan area or surrounding communities with a parent, step-parent, or surrogate parent; AND
  • Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).

You may not qualify if:

  • Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures
  • Adolescent deemed dangerous to self or others during evaluation
  • Services other than outpatient treatment required for the adolescent (e.g., inpatient, detoxification)
  • Adolescent already has participated in treatment project at CFAR; AND
  • A sibling is already participating in project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Res. Inst. Center for Family & Adolescent Research (CFAR)

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Holly B. Waldron, Ph.D.

    Oregon Research Institute Center for Family and Adolescent Research (ORI/CFAR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

January 1, 2004

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations