Substance Use Disorders Clinical Trial
— HCCOfficial title:
Feasibility and Acceptability of Home-based Continuing Care
Verified date | March 2023 |
Source | Public Health Management Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Family Training Program | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Treatment Research Institute | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Young Adult Drug Use from Baseline to 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). | Baseline, Weekly, 16 week and 32 week follow-ups | |
Secondary | Change in Parent and Young Adult Relationship Satisfaction from Baseline to 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. | Baseline, 16 week and 32 week follow-ups | |
Secondary | Parent and Young Adult Treatment Retention | Weeks of participation in the home-based continuing care intervention | 32 weeks post baseline | |
Secondary | Parent and Young Adult Recruitment Rate by percent approached | We will measure the percent of young adults and parents that were approached and agreed to participate in the study. | 10 month recruitment period | |
Secondary | Parent and Young Adult Engagement in HCC by urine sample collected | We will measure the percent of urine samples the parent collects from the young adult. | 32 week intervention period | |
Secondary | Parent and Young Adult Treatment Acceptability | Participants will complete the Treatment Evaluation Inventory | 16 week and 32 week follow-ups | |
Secondary | Parent and Young Adult Research Retention | Follow-up rates | 16 week and 32 week follow-ups | |
Secondary | Parent and Young Adult Engagement in HCC by number of calls completed | We will measure the number of telephone counseling calls completed by the parent and young adult. | 32 week intervention period | |
Secondary | Parent and Young Adult Recruitment Rate by monthly recruitment rate | We will measure the mean number of parent and young adult participants that are recruited per month. | 10 month recruitment period |
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