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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Substance Use Disorders, Treatment Refusal
- 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 group | Role | What they receive |
|---|---|---|
| G-CRT | Experimental | Group Community Reinforcement Training for parents Receives: Behavioral: Group Community Reinforcement Training for Parents |
| I-CRT | Active comparator | Individual 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.
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)
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.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica M Finstad, Ph.D., Principal investigator, Oregon Research Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Community Reinforcement Training for Parents of Treatment-Elusive Youth
- ClinicalTrials.gov ID
- NCT01829789
- Acronym / sponsor ID
- POP / 1R34DA034301
- Conditions
- Substance Use Disorders, Treatment Refusal
- Keywords
- Adolescents, Teens, Parents, Parenting, Substance Abuse, Treatment Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CRT | Experimental | Behavioral: Group Community Reinforcement Training for ParentsGroup Community Reinforcement Training for parents |
| I-CRT | Active comparator | Behavioral: Individual Community Reinforcement Training for ParentsIndividual Community Reinforcement Training for parents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Community Reinforcement Training for ParentsAlso: G-CRT | Behavioural | G-CRT |
| Individual Community Reinforcement Training for ParentsAlso: I-CRT | Behavioural | I-CRT |
Primary outcome
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.
1 secondary outcome
Timeline Followback (TLFB) interview
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica M Finstad, Ph.D. principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
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.