Family and Adolescent Motivational Incentives for Leveraging Youth (FAMILY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Oregon Research Institute
Sponsor:
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT01736995
First received: November 5, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Substance-Related Disorders
Behavioral: Functional Family Therapy
Behavioral: Motivational Enhancement Tx/Cognitive Behavioral Tx
Behavioral: Contingency Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family and Adolescent Motivational Incentives for Leveraging Youth

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Urine Assays - NIDA 12 Test Panel [ Time Frame: Up to 12-months after randomization ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Timeline Followback semi-structured interview (TLFB) [ Time Frame: Up to 12-months after randomization ] [ Designated as safety issue: No ]
    The TLFB will be used to determine the percent days of substance use (primary measure), excluding tobacco, as well as abstinence days and binge drinking days.


Estimated Enrollment: 160
Study Start Date: July 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational/Cog Beh Tx-Contingency Mgmt
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
Other Name: CM
Experimental: Functional Family Tx- Contingency Mgmt
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 Therapy
Other Name: FFT
Behavioral: Contingency Management
Other Name: CM
Experimental: Motivational/Cog Beh Tx
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
Other Name: MET/CBT
Experimental: Functional Family Tx
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
Other Name: FFT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 13 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736995

Contacts
Contact: Michael S. Robbins, Ph.D. 541-484-2123 ext 2303 mrobbins@ori.org

Locations
United States, New Mexico
Oregon Research Institute Center for Family and Adolescent Research Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Janet L. Brody, Ph.D.    505-842-8932    jbrody@ori.org   
Sub-Investigator: Holly Waldron, Ph.D.         
Sub-Investigator: Charles W. Turner, Ph.D.         
Sub-Investigator: Janet L. Brody, Ph.D.         
Sub-Investigator: Catherine Stanger, Ph.D.         
Sponsors and Collaborators
Oregon Research Institute
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Michael Robbins, Ph.D. Oregon Research Institute; Functional Family Therapy, Inc.
  More Information

No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01736995     History of Changes
Other Study ID Numbers: 1R01DA032723-01A1
Study First Received: November 5, 2012
Last Updated: February 3, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Oregon Research Institute:
Substance Abuse
Adolescents
Families
Functional Family Therapy
Cognitive Behavioral Therapy
Motivational Therapy
Contingency Management

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014