Clinical trial NCT02152033: Home-based Continuing Care for Young Adults Leaving Residential Substance Abuse Treatment
Official title: Feasibility and Acceptability of Home-based Continuing Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Substance Abuse
Continuing Care
Recovery
Substance Abuse Treatment
Parent
Family
Young Adult
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Young Adult Drug Use from Baseline to 16 week and 32 week follow-ups
timeFrame: Baseline, Weekly, 16 week and 32 week follow-ups
Secondary outcomes:
measure: Change in Parent and Young Adult Relationship Satisfaction from Baseline to 16 week and 32 week follow-ups
timeFrame: Baseline, 16 week and 32 week follow-ups
measure: Parent and Young Adult Treatment Retention
timeFrame: 32 weeks post baseline
measure: Parent and Young Adult Recruitment Rate by percent approached
timeFrame: 10 month recruitment period
measure: Parent and Young Adult Engagement in HCC by urine sample collected
timeFrame: 32 week intervention period
measure: Parent and Young Adult Treatment Acceptability
timeFrame: 16 week and 32 week follow-ups
measure: Parent and Young Adult Research Retention
timeFrame: 16 week and 32 week follow-ups
measure: Parent and Young Adult Engagement in HCC by number of calls completed
timeFrame: 32 week intervention period
measure: Parent and Young Adult Recruitment Rate by monthly recruitment rate
timeFrame: 10 month recruitment period
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Family Training Program
state: Pennsylvania
Study officials:
affiliation: Treatment Research Institute
name: Kimberly C Kirby, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: