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Individual vs. Group Community Reinforcement Training to Help Parents of Substance-using Treatment-refusing Youth (POP)

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ClinicalTrials.gov Identifier: NCT01829789
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute

Tracking Information
First Submitted Date  ICMJE April 9, 2013
First Posted Date  ICMJE April 11, 2013
Last Update Posted Date September 30, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2013)
Adolescent treatment engagement [ Time Frame: 4 months ]
An adolescent may enter the CBT treatment program ("treatment engagement") at any point during the 4-month time period after his or her parents begin I-CRT or G-CRT therapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2013)
Timeline Followback (TLFB) interview [ Time Frame: 9 months ]
The TLFB is an interview to assess the quantity, frequency, and pattern of illicit substance use. Parents provide collateral data on their adolescents' substance use in the 3 months prior to enrollment. Adolescents report on their own substance use for the 3 months prior to their parents' enrollment through 6 months after enrollment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 9, 2013)
Medical Outcome Studies Social Support Survey [ Time Frame: 9 months ]
The MOS consists of four support subscales (Emotional/Informational, Tangible, Affectionate, and Positive Social) and an overall functional social support index. This measure will be completed by parents at baseline (about the 3 months prior to enrollment) and at 3- and 6-month follow-up points. It will be used to compare perceived social support for parents in the G-CRT versus I-CRT interventions.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Individual vs. Group Community Reinforcement Training to Help Parents of Substance-using Treatment-refusing Youth
Official Title  ICMJE Group Community Reinforcement Training for Parents of Treatment-Elusive Youth
Brief Summary The purpose of this study is to test the efficacy and cost-effectiveness of Community Reinforcement Training (CRT) provided in a group therapy format. The goals of CRT are to teach parents behavioral and communication skills to influence their youth's drug use and encourage them to enter treatment. Thirty parents will be randomly assigned to Group CRT and 30 will be randomly assigned to traditional, Individual CRT. Youth engaged in treatment will receive individual Cognitive Behavioral Therapy. Families are assessed for adolescent substance use and other areas of individual and family functioning. It is expected that Group CRT will be more effective for encouraging youth entry into treatment and improving parental functioning.
Detailed Description

Very few youth with drug abuse or dependence in the United States receive treatment. This population of untreated youth represents a massive "treatment gap" in adolescent health care that renders impotent a potentially important avenue for preventing chronic drug abuse and related difficulties. The lack of motivation for treatment characterizing most adolescent drug abusers significantly decreases the likelihood these youth will enter treatment, barring mandates from the legal system or other social institutions. Efficacy studies have demonstrated that Community Reinforcement Training (CRT), an approach that involves teaching parents how to engage their youth into treatment, can work to recruit 60-80% of these treatment-elusive youth. CRT is traditionally provided in an individual therapy format to one or both parents. This study will improve upon our prior work by using a group format to provide a less costly procedure for engaging youth into treatment and to make it more portable to treatment agencies, schools, juvenile justice, and other community organizations seeking to offer support to parents or engage youth in treatment, thus significantly increasing the adoption and sustainability of the approach.

This study will examine the efficacy of the group format (G-CRT) for helping parents engage their unmotivated, resistant youth in treatment compared to the traditional individual format (I-CRT). Parents (n = 60) will be randomly assigned to G-CRT or to I-CRT. We will evaluate the differential efficacy of G-CRT, relative to I-CRT, on rates of adolescent engagement in treatment. We expect that G-CRT, compared to I-CRT, will also be associated with greater parent encouragement of adolescent sobriety, perceived social support, and family functioning. We also predict that changes on these process variables will predict increased success in engaging adolescents. We will also examine treatment outcomes for youth engaged in Cognitive Behavioral Therapy as a function of parental involvement in G-CRT or I-CRT. We predict enhanced support received by parents in G-CRT will result in greater reductions in drug use and lower levels of HIV-risk behaviors, outcomes hypothesized to be mediated by motivation to change and sessions attendance. Finally, we will conduct an informal cost-effectiveness analysis to derive preliminary estimates of the relative costs of each treatment modality per outcome unit and hypothesize that G-CRT will be more cost effective than I-CRT by virtue of having higher clinical effectiveness and lower costs. Successful outcomes here will provide the basis for a full clinical trial with larger samples.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Substance Use Disorders
  • Treatment Refusal
Intervention  ICMJE
  • Behavioral: Group Community Reinforcement Training for Parents
    Other Name: G-CRT
  • Behavioral: Individual Community Reinforcement Training for Parents
    Other Name: I-CRT
Study Arms  ICMJE
  • Experimental: G-CRT
    Group Community Reinforcement Training for parents
    Intervention: Behavioral: Group Community Reinforcement Training for Parents
  • Active Comparator: I-CRT
    Individual Community Reinforcement Training for parents
    Intervention: Behavioral: Individual Community Reinforcement Training for Parents
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Parents have an adolescent between 15-20 years
  • Parents have had contact with the adolescent on at least 40% of the past 12 weeks
  • Parents have some knowledge or evidence that the adolescent would meet DSM-IV diagnostic criteria for a substance use disorder
  • Adolescent has explicitly refused to attend any intake or therapy sessions
  • Adolescent is not under a current court mandate for treatment or has refused to comply with the mandate
  • English-speaking capability (parents and adolescents)

Exclusion Criteria:

  • Evidence of adolescent psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures
  • Adolescent had received drug treatment (except detoxification) in the past 12 weeks.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01829789
Other Study ID Numbers  ICMJE 1R34DA034301( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oregon Research Institute
Study Sponsor  ICMJE Oregon Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erica M Finstad, Ph.D. Oregon Research Institute
PRS Account Oregon Research Institute
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP