NCT02152033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

May 20, 2014

Last Update Submit

March 27, 2023

Conditions

Keywords

Substance AbuseContinuing CareRecoverySubstance Abuse TreatmentParentFamilyYoung Adult

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change in Parent and Young Adult Relationship Satisfaction from Baseline to 16 week and 32 week follow-ups

    Baseline, 16 week and 32 week follow-ups

  • Parent and Young Adult Treatment Retention

    32 weeks post baseline

  • Parent and Young Adult Recruitment Rate by percent approached

    10 month recruitment period

  • Parent and Young Adult Engagement in HCC by urine sample collected

    32 week intervention period

  • Parent and Young Adult Treatment Acceptability

    16 week and 32 week follow-ups

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Services as Usual

Interventions

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.

Home-based Continuing Care

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.

Services as Usual

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Training Program

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Kimberly C Kirby, Ph.D.

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

June 2, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations