Home-based Continuing Care for Young Adults Leaving Residential Substance Abuse Treatment (HCC)
Primary Purpose
Substance Use Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based Continuing Care
Services as Usual
Sponsored by
About this trial
This is an interventional supportive care trial for Substance Use Disorders focused on measuring Substance Abuse, Continuing Care, Recovery, Substance Abuse Treatment, Parent, Family, Young Adult
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
Sites / Locations
- Family Training Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Home-based Continuing Care
Services as Usual
Arm Description
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.
YAs completing residential care usually are referred to continuing outpatient services and/or self-help groups.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Parent and Young Adult Treatment Retention
Weeks of participation in the home-based continuing care intervention
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.
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.
Parent and Young Adult Treatment Acceptability
Participants will complete the Treatment Evaluation Inventory
Parent and Young Adult Research Retention
Follow-up rates
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.
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.
Full Information
NCT ID
NCT02152033
First Posted
May 20, 2014
Last Updated
March 27, 2023
Sponsor
Treatment Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02152033
Brief Title
Home-based Continuing Care for Young Adults Leaving Residential Substance Abuse Treatment
Acronym
HCC
Official Title
Feasibility and Acceptability of Home-based Continuing Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Substance Abuse, Continuing Care, Recovery, Substance Abuse Treatment, Parent, Family, Young Adult
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home-based Continuing Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Services as Usual
Arm Type
Other
Arm Description
YAs completing residential care usually are referred to continuing outpatient services and/or self-help groups.
Intervention Type
Behavioral
Intervention Name(s)
Home-based Continuing Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Services as Usual
Intervention Description
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 Measure Information:
Title
Change in Young Adult Drug Use from Baseline to 16 week and 32 week follow-ups
Description
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).
Time Frame
Baseline, Weekly, 16 week and 32 week follow-ups
Secondary Outcome Measure Information:
Title
Change in Parent and Young Adult Relationship Satisfaction from Baseline to 16 week and 32 week follow-ups
Description
Parent participants will complete the Parent Happiness with Youth Scale and young adult participants will complete the Youth Happiness with Parents scale.
Time Frame
Baseline, 16 week and 32 week follow-ups
Title
Parent and Young Adult Treatment Retention
Description
Weeks of participation in the home-based continuing care intervention
Time Frame
32 weeks post baseline
Title
Parent and Young Adult Recruitment Rate by percent approached
Description
We will measure the percent of young adults and parents that were approached and agreed to participate in the study.
Time Frame
10 month recruitment period
Title
Parent and Young Adult Engagement in HCC by urine sample collected
Description
We will measure the percent of urine samples the parent collects from the young adult.
Time Frame
32 week intervention period
Title
Parent and Young Adult Treatment Acceptability
Description
Participants will complete the Treatment Evaluation Inventory
Time Frame
16 week and 32 week follow-ups
Title
Parent and Young Adult Research Retention
Description
Follow-up rates
Time Frame
16 week and 32 week follow-ups
Title
Parent and Young Adult Engagement in HCC by number of calls completed
Description
We will measure the number of telephone counseling calls completed by the parent and young adult.
Time Frame
32 week intervention period
Title
Parent and Young Adult Recruitment Rate by monthly recruitment rate
Description
We will measure the mean number of parent and young adult participants that are recruited per month.
Time Frame
10 month recruitment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly C Kirby, Ph.D.
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Training Program
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Home-based Continuing Care for Young Adults Leaving Residential Substance Abuse Treatment
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