search
Back to results

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

Primary Purpose

Substance Use Disorders, Treatment Refusal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Community Reinforcement Training for Parents
Individual Community Reinforcement Training for Parents
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Adolescents, Teens, Parents, Parenting, Substance Abuse, Treatment Efficacy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Center for Family and Adolescent Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

G-CRT

I-CRT

Arm Description

Group Community Reinforcement Training for parents

Individual Community Reinforcement Training for parents

Outcomes

Primary Outcome Measures

Adolescent treatment engagement
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.

Secondary Outcome Measures

Timeline Followback (TLFB) interview
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.

Full Information

First Posted
April 9, 2013
Last Updated
September 29, 2016
Sponsor
Oregon Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01829789
Brief Title
Individual vs. Group Community Reinforcement Training to Help Parents of Substance-using Treatment-refusing Youth
Acronym
POP
Official Title
Group Community Reinforcement Training for Parents of Treatment-Elusive Youth
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Treatment Refusal
Keywords
Adolescents, Teens, Parents, Parenting, Substance Abuse, Treatment Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G-CRT
Arm Type
Experimental
Arm Description
Group Community Reinforcement Training for parents
Arm Title
I-CRT
Arm Type
Active Comparator
Arm Description
Individual Community Reinforcement Training for parents
Intervention Type
Behavioral
Intervention Name(s)
Group Community Reinforcement Training for Parents
Other Intervention Name(s)
G-CRT
Intervention Type
Behavioral
Intervention Name(s)
Individual Community Reinforcement Training for Parents
Other Intervention Name(s)
I-CRT
Primary Outcome Measure Information:
Title
Adolescent treatment engagement
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Timeline Followback (TLFB) interview
Description
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.
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Medical Outcome Studies Social Support Survey
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica M Finstad, Ph.D.
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Family and Adolescent Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs