NCT01736995

Brief Summary

Research has provided support for the efficacy of cognitive-behavioral and family interventions for adolescent substance use disorders (SUD), HIV-risk behaviors, and related problems. Despite support for these interventions, substantial heterogeneity in treatment outcomes and high relapse rates has been consistently found across studies. Such variability highlights the need for innovative strategies to broaden the impact and strengthen the durability of effects of adolescent substance abuse treatments. Over the past two decades, research has shown the positive effects of contingency management (CM) methods on reductions in substance use and other problem behaviors. When combined with evidence-based practices, emerging research suggests that CM integration may also be effective for adolescent substance abusers. The proposed Stage II efficacy trial examines the integration of CM with two empirically-supported interventions: group MET/CBT and FFT. By comparing two intervention modalities (group vs. family, the study provides a unique opportunity to examine the robustness of the effects of CM across established adolescent treatments, and to compare change mechanisms that may account for treatment outcomes. In the proposed research, substance abusing adolescents (n = 160) will be randomly assigned either to FFT or group MET/CBT. Random assignment will also be used to determine whether or not youth will receive a CM condition that provides incentives for abstinence (i.e., clean urine screens) and treatment participation. The primary aim of the study is to examine the efficacy of an integrated CM intervention for the two evidence-based treatments for adolescents, MET/CBT and FFT, compared to these treatments without CM on drug abuse abstinence (a) during treatment (i.e., speed of effects) and (b) at post-treatment follow-up assessments (i.e., durability of effects). A second aim of the study is to evaluate the effects of CM on hypothesized mediators of the intervention effects in the MET/CBT and the FFT conditions. The investigators anticipate that the CM conditions, compared to the nonCM conditions, are more likely to accelerate the adolescent's motivation (1) to achieve abstinence, to attend and participate in treatment, and to complete homework assignments. The investigators will also examine the effects of the interventions on HIV-risk behaviors and expect that CM will demonstrate the largest reductions in HIV-risk behaviors compared to the nonCM conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

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

July 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

5.8 years

First QC Date

November 5, 2012

Last Update Submit

May 1, 2018

Conditions

Keywords

Substance AbuseAdolescentsFamiliesFunctional Family TherapyCognitive Behavioral TherapyMotivational TherapyContingency Management

Outcome Measures

Primary Outcomes (1)

  • Urine Assays - NIDA 12 Test Panel

    The NIDA 12 Test Panel is a card device with 12 finger-like prongs, dipped in a urine sample to screen for the presence or absence of illegal substances including AMP (amphetamine), BAR (barbiturates), BZO (benzodiazepines), COC (cocaine), M-AMP/MDMA (methamphetamine, ice, speed, ecstasy), MTD (methadone), MOR (morphine), OXY (Oxycodone), PCP, PPX (Propoxyphene), OPI (Opiates), THC (marijuana). Alcohol use will be measured using Saliva Screens (Alco-Screen 02), a simple, non-invasive, one-step test that provides results in four minutes and detects alcohol levels of .02 or greater.

    Up to 12-months after randomization

Secondary Outcomes (1)

  • Timeline Followback semi-structured interview (TLFB)

    Up to 12-months after randomization

Study Arms (4)

Motivational/Cog Beh Tx-Contingency Mgmt

EXPERIMENTAL

The group Motivational Enhancement Tx/Cognitive Behavioral Tx (MET/CBT) treatment is a peer-focused, multi-component intervention involving 2 initial individual motivational sessions followed by 12 group sessions that includes a functional analysis of behavior to identify antecedents and consequences of drug use and skills training for coping with cravings, enhancing assertive communication, drug refusal, managing negative moods, problem-solving, decision-making, and relapse prevention. The additional inclusion of contingency management (CM) methods will provide immediate, tangible reinforcers as a consequence delivered contingently upon evidence of abstinence from substance use or other desirable behavior.

Behavioral: Contingency Management

Functional Family Tx- Contingency Mgmt

EXPERIMENTAL

Functional Family Therapy (FFT) is a brief treatment for youth with problem behaviors, including substance abuse that consists of 12 to 14 weekly family sessions. The FFT treatment is applied in five distinct phases: Engagement, Motivation, Relational Assessment, Behavior Change, and Generalization and each phase has specific goals, techniques, and therapist skills. The additional inclusion of contingency management (CM) methods will provide immediate, tangible reinforcers to the family as a consequence delivered contingently upon evidence of abstinence from substance use or other desirable behavior.

Behavioral: Functional Family TherapyBehavioral: Contingency Management

Motivational/Cog Beh Tx

EXPERIMENTAL

The group Motivational Enhancement Tx/Cognitive Behavioral Tx (MET/CBT) treatment is a peer-focused, multi-component intervention involving 2 initial individual motivational sessions followed by 12 group sessions that includes a functional analysis of behavior to identify antecedents and consequences of drug use and skills training for coping with cravings, enhancing assertive communication, drug refusal, managing negative moods, problem-solving, decision-making, and relapse prevention.

Behavioral: Motivational Enhancement Tx/Cognitive Behavioral Tx

Functional Family Tx

EXPERIMENTAL

Functional Family Therapy (FFT) is a brief treatment for youth with problem behaviors, including substance abuse that consists of 12 to 14 weekly family sessions. The FFT treatment is applied in five distinct phases: Engagement, Motivation, Relational Assessment, Behavior Change, and Generalization and each phase has specific goals, techniques, and therapist skills.

Behavioral: Functional Family Therapy

Interventions

Also known as: FFT
Functional Family TxFunctional Family Tx- Contingency Mgmt
Also known as: MET/CBT
Motivational/Cog Beh Tx
Also known as: CM
Functional Family Tx- Contingency MgmtMotivational/Cog Beh Tx-Contingency Mgmt

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 17 years of age
  • Meets DSM-IV diagnostic criteria for substance abuse or dependence
  • Living at home with the participating parent
  • 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 the understanding of study instruments and procedures
  • Deemed dangerous to self or others at intake
  • Services other than outpatient treatment are required for the youth (e.g., inpatient, detoxification)
  • Marijuana use is reported as being less than 13% of the previous 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute Center for Family and Adolescent Research

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Michael Robbins, Ph.D.

    Oregon Research Institute; Functional Family Therapy, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 29, 2012

Study Start

July 1, 2012

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations