Substance Use DisordersHCCNCT02152033
Home-based Continuing Care for Young Adults Leaving Residential Substance Abuse Treatment
A study testing Home-based Continuing Care and Services as Usual in people with Substance Use Disorders, run by Treatment Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Home-based Continuing Care and Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Training Program
Philadelphia, Pennsylvania, 19103
About this study
Official title: Feasibility and Acceptability of Home-based Continuing Care
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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Home-based Continuing Care, Services as Usual
- Keywords
- Substance Abuse, Continuing Care, Recovery, Substance Abuse Treatment, Parent, Family, Young Adult
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Continuing CareBehavioural
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 UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based Continuing Care | Experimental | 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. Receives: Behavioral: Home-based Continuing Care |
| Services as Usual | Other | YAs completing residential care usually are referred to continuing outpatient services and/or self-help groups. Receives: Behavioral: Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Weekly, 16 week and 32 week follow-ups
Secondary outcomes (8)
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.
Measured: Baseline, 16 week and 32 week follow-ups
Parent and Young Adult Treatment Retention
Weeks of participation in the home-based continuing care intervention
Measured: 32 weeks post baseline
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.
Measured: 10 month recruitment period
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.
Measured: 32 week intervention period
Parent and Young Adult Treatment Acceptability
Participants will complete the Treatment Evaluation Inventory
Measured: 16 week and 32 week follow-ups
Parent and Young Adult Research Retention
Follow-up rates
Measured: 16 week and 32 week follow-ups
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.
Measured: 32 week intervention period
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.
Measured: 10 month recruitment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2016
- Study completionSep 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kimberly C Kirby, Ph.D., Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152033
- Sponsor's protocol ID
- R21DA036818
- Other IDs
- R21DA036818
- Acronym
- HCC
- Status last verified
- Mar 2023
- First submitted
- 20 May 2014
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Home-based Continuing Care
- ClinicalTrials.gov ID
- NCT02152033
- Acronym / sponsor ID
- HCC / R21DA036818
- Conditions
- Substance Use Disorders
- Keywords
- Substance Abuse, Continuing Care, Recovery, Substance Abuse Treatment, Parent, Family, Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Jun 2014 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based Continuing Care | Experimental | Behavioral: Home-based Continuing CareThe 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. |
| Services as Usual | Other | Behavioral: Services as UsualYAs completing residential care usually are referred to continuing outpatient services and/or self-help groups. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Home-based Continuing CareAll 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. | Behavioural | Home-based Continuing Care |
| Services as UsualYoung 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. | Behavioural | Services as Usual |
Primary outcome
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).
8 secondary outcomes
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 and Young Adult Treatment Retention
Time frame: 32 weeks post baseline
Parent and Young Adult Recruitment Rate by percent approached
Time frame: 10 month recruitment period
Parent and Young Adult Engagement in HCC by urine sample collected
Time frame: 32 week intervention period
Parent and Young Adult Treatment Acceptability
Time frame: 16 week and 32 week follow-ups
Parent and Young Adult Research Retention
Time frame: 16 week and 32 week follow-ups
Parent and Young Adult Engagement in HCC by number of calls completed
Time frame: 32 week intervention period
Parent and Young Adult Recruitment Rate by monthly recruitment rate
Time frame: 10 month recruitment period
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 28 Mar 2023.
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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.
Kimberly C Kirby, Ph.D. principal investigator
Treatment 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 Home-based Continuing Care and Services as Usual in people with Substance Use Disorders, run by Treatment 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 7 inclusion and 6 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 28 Mar 2023. 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?
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). 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 28 Mar 2023.