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Home-based Continuing Care for Young Adults Leaving Residential Substance Abuse Treatment (HCC)

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ClinicalTrials.gov Identifier: NCT02152033
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : October 19, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Treatment Research Institute

Brief Summary:
The purpose of this project is to develop and test a Home-based Continuing Care intervention that will help parents support the recovery of their Young Adult (YA) child who is leaving residential substance abuse treatment. The two phase pilot study will 1) interview 50 parents and 50 YAs recruited from residential treatment programs and from parent groups to inform the development of the intervention and 2) conduct a two-arm pilot study that will recruit a maximum of 20 parents and their young adult children into one of two conditions (Home-based Continuing Care [HCC] intervention group or Services as Usual [SAU] comparison group) with the main goal of determining whether conducting such an intervention is acceptable and sustainable, and to collect preliminary efficacy data. We hypothesize that pilot testing will indicate that: (a) HCC is acceptable and potentially sustainable; (b) conducting a randomized clinical trial is feasible, and (c) the magnitude of outcomes from HCC will be clinically meaningful.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: Home-based Continuing Care Behavioral: Services as Usual Not Applicable

Detailed Description:

Several models of continuing care (CC) have been studied for adolescents and Young Adults (YAs) including online relapse prevention, brief telephone counseling and Assertive Continuing Care (ACC). Five sessions of in-person therapy or brief telephone counseling both have reduced relapse in youth completing treatment relative to a no CC condition, consistent with a growing body of research with adults supporting the efficacy of telephone-based CC (TCC). ACC has been thoroughly evaluated for adolescents. Some applications also have incorporated contingency management (CM) for engaging in activities including needed services; but ACC has not applied CM to biologically-verified abstinence -- an efficacious approach in adult CC. A significant drawback of ACC is that it is quite intensive, requiring extended clinician training and home visits. This increases the costs of the intervention and the difficulty of dissemination and implementation; therefore we plan to develop a less clinician-intensive continuing care model for YAs.

The two phase pilot study will 1) interview 50 parents and 50 YAs recruited from residential substance abuse treatment programs and from parent groups to inform the development of the intervention and 2) conduct a two-arm pilot study that will recruit a maximum of 20 parents and their YA children into one of two conditions (Home-based Continuing Care [HCC] intervention group or Services as Usual [SAU] comparison group) with the main goal of determining whether conducting such an intervention is acceptable and sustainable, and to collect preliminary efficacy data. We hypothesize that pilot testing will indicate that: (a) HCC is acceptable and potentially sustainable; (b) conducting a randomized clinical trial is feasible, and (c) the magnitude of outcomes from HCC will be clinically meaningful.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Acceptability of Home-based Continuing Care
Study Start Date : July 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Home-based Continuing Care
The components of Home-based Continuing Care (HCC) include brief parent training, brief Young Adult (YA) orientation and recovery planning, telephone-based continuing care (TCC) and home-based contingency management. Both parent and YA participants will attend sessions with a family specialist.
Behavioral: Home-based Continuing Care
All sessions will occur over the phone or Cisco WebEx meetings. Parents will participate in 5 individual sessions and 1 joint session with their child (45-50 min. each). Young Adults (YAs) will participate in 1-3 individual meetings (30- 45 min. each) and 1 joint session (45-50 min.). In addition, YAs will be contacted weekly for the first 8 weeks of HCC, then every other week for the remaining 24 weeks (20 calls total). He or she will be asked questions addressing risk and protective factors for relapse. Finally, parents will be trained to collect and test their child's urine sample and deliver incentives to the YA contingent upon biologically-verified abstinence and verified engagement in continuing service plan activities. Urine samples will be collected regularly over a 32 week period.

Services as Usual
YAs completing residential care usually are referred to continuing outpatient services and/or self-help groups.
Behavioral: Services as Usual
Young Adults (YAs) will be told to follow the continuing service plan recommended by the residential treatment program. Parents will be told to support this and be sent information on continuing care developed by the Treatment Research Institute and the Partnership @ Drugfree.org (http://continuingcare.drugfree.org). We will provide no supplemental services during the study. We will train parents; however, on how to collect urine samples for research purposes only. They will not be trained on how to test the urine sample, only how to collect it and mail the sample to our staff for testing. We will offer separate 4 hour-workshops to parents and YAs after they have completed participation as an added study participation incentive for this group.




Primary Outcome Measures :
  1. Change in Young Adult Drug Use from Baseline to 16 week and 32 week follow-ups [ Time Frame: Baseline, Weekly, 16 week and 32 week follow-ups ]
    Young Adult participants will complete a Timeline Follow Back (Baseline, 16 week and 32 week follow-ups) and provide a urine sample to be tested for drug and alcohol use (Baseline, Weekly, 16 week and 32 week follow-ups).


Secondary Outcome Measures :
  1. Change in Parent and Young Adult Relationship Satisfaction from Baseline to 16 week and 32 week follow-ups [ Time Frame: Baseline, 16 week and 32 week follow-ups ]
    Parent participants will complete the Parent Happiness with Youth Scale and young adult participants will complete the Youth Happiness with Parents scale.

  2. Parent and Young Adult Treatment Retention [ Time Frame: 32 weeks post baseline ]
    Weeks of participation in the home-based continuing care intervention

  3. Parent and Young Adult Recruitment Rate by percent approached [ Time Frame: 10 month recruitment period ]
    We will measure the percent of young adults and parents that were approached and agreed to participate in the study.

  4. Parent and Young Adult Engagement in HCC by urine sample collected [ Time Frame: 32 week intervention period ]
    We will measure the percent of urine samples the parent collects from the young adult.

  5. Parent and Young Adult Treatment Acceptability [ Time Frame: 16 week and 32 week follow-ups ]
    Participants will complete the Treatment Evaluation Inventory

  6. Parent and Young Adult Research Retention [ Time Frame: 16 week and 32 week follow-ups ]
    Follow-up rates

  7. Parent and Young Adult Engagement in HCC by number of calls completed [ Time Frame: 32 week intervention period ]
    We will measure the number of telephone counseling calls completed by the parent and young adult.

  8. Parent and Young Adult Recruitment Rate by monthly recruitment rate [ Time Frame: 10 month recruitment period ]
    We will measure the mean number of parent and young adult participants that are recruited per month.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parent is 21 years of age or older
  • Young Adult (YA) is 18-25 years of age
  • YA's primary drug of abuse is prescription or other opiates
  • Parent must be the custodial parent or former guardian or other caretaker of the YA
  • YA is in residential treatment
  • Parent and YA plan to live in the same residence during the intervention (32 weeks)
  • Both Parent and YA provide written informed consent and pass the consent quiz testing knowledge of basic elements of informed consent and study requirements (including home urine testing).

Exclusion Criteria:

  • Parent currently has a substance use disorder (SUD) as determined via DSM-IV-TR criteria or a history of SUD and in recovery for less than 2 years
  • Parent or YA has been diagnosed as having, or behaves in, a manner consistent with having significant cognitive impairment (e.g., an unrelieved psychosis or other serious mental illness)
  • YA reports suicidal ideation with a plan, or engaged in suicidal behavior during residential treatment
  • YA has a recent history of severe violence toward the parent (e.g., involving weapons or hospitalization)
  • YA's residential program provides comprehensive continuing services
  • YA does not consent to participation within 2 weeks of discharge

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152033


Locations
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United States, Pennsylvania
Family Training Program
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Treatment Research Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kimberly C Kirby, Ph.D. Treatment Research Institute

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Responsible Party: Treatment Research Institute
ClinicalTrials.gov Identifier: NCT02152033     History of Changes
Other Study ID Numbers: R21DA036818 ( U.S. NIH Grant/Contract )
R21DA036818 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Keywords provided by Treatment Research Institute:
Substance Abuse
Continuing Care
Recovery
Substance Abuse Treatment
Parent
Family
Young Adult
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders