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Substance Use DisordersPOPNCT01829789

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

A study testing Group Community Reinforcement Training for Parents and Individual Community Reinforcement Training for Parents in people with Substance Use Disorders and Treatment Refusal, run by Oregon Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Substance Use Disorders, Treatment Refusal
What is being tested?
Group Community Reinforcement Training for Parents and Individual Community Reinforcement Training for Parents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Apr 2013to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Family and Adolescent Research

    Portland, Oregon, 97232

Other trials in United States

About this study

Official title: Group Community Reinforcement Training for Parents of Treatment-Elusive Youth

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.

Read the 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.

Being tested
Group Community Reinforcement Training for Parents, Individual Community Reinforcement Training for Parents
Keywords
Adolescents, Teens, Parents, Parenting, Substance Abuse, Treatment Efficacy
Medical subject headings
Substance-Related Disorders, Treatment Refusal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group Community Reinforcement Training for ParentsBehavioural

    Also called G-CRT

  • Individual Community Reinforcement Training for ParentsBehavioural

    Also called I-CRT

Study groups in NCT01829789
Study groupRoleWhat they receive
G-CRTExperimentalGroup Community Reinforcement Training for parents
Receives: Behavioral: Group Community Reinforcement Training for Parents
I-CRTActive comparatorIndividual Community Reinforcement Training for parents
Receives: Behavioral: Individual Community Reinforcement Training for Parents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 months

Secondary outcomes (1)
  1. 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.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionNov 2015
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01829789
Sponsor's protocol ID
1R34DA034301
Acronym
POP
Status last verified
Sep 2016
First submitted
9 Apr 2013
Last updated
30 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Group Community Reinforcement Training for Parents and Individual Community Reinforcement Training for Parents in people with Substance Use Disorders and Treatment Refusal, run by Oregon Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adolescent treatment engagement (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.

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