Transitional Treatment of Adolescents in Family Therapy (Transitions)

August 4, 2014 updated by: Oregon Research Institute
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Oregon Res. Inst. Center for Family & Adolescent Research (CFAR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least one parent, step-parent, or surrogate parent willing to participate in the study
  2. 13 to 18 years if age
  3. meets DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence
  4. Lives in the Albuquerque metropolitan area or surrounding communities with a parent, step-parent, or surrogate parent; AND
  5. Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1
Following 12 weeks of Functional Family Therapy (FFT), semi-weekly therapist phone calls for eight weeks.
Behavioral: MTI, Minimal Transitional Intervention
Following 12 weeks of Functional Family Therapy (FFT), semi-weekly phone calls from a therapist for eight weeks.
Active Comparator: 2
Following 12 weeks of FFT, weekly one-hour group therapy for eight weeks
Behavioral: GTI, Group Transitional Intervention
Following 12 weeks of FFT, weekly one-hour sessions of group therapy for eight weeks.
Active Comparator: 3
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Drug use levels for adolescents who have received family therapy and one of the three aftercare regimens
Time Frame: pretx and 6 wks, 4 , 7 and 12 mos. post initial therapy session
pretx and 6 wks, 4 , 7 and 12 mos. post initial therapy session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Holly B. Waldron, Ph.D., Oregon Research Institute Center for Family and Adolescent Research (ORI/CFAR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DA15762
  • R01DA015762 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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