- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02577666
Evaluation of EBT With Young, Substance Abusing Homeless Mothers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Homeless mothers with young children in their care contend with high rates of substance use, HIV risk, physical and mental health problems and parenting stress. These struggles are in addition to homelessness and meeting the basic needs of themselves and their children. However, a very limited number of studies have examined mother and child outcomes associated with housing and supportive services. Even with increased focus on those experiencing homelessness, the number of homeless families continues to rise, with the demand for temporary shelter so high that many cities are unable to meet the needs of these families. A comprehensive intervention that can be offered outside the shelter setting may offer greater reach to those experiencing homelessness who do not make it in to the shelter system, and for those communities that do not have shelters available. Among the young homeless, those under age 25, research documents that the majority (70%) have never used shelter services. Research attention towards identifying efficacious interventions for this population which address the multiple needs of these families is thus considered an important focus. The proposed intervention (Ecologically-Based Treatment, EBT) includes housing and supportive services and utilizes an ecological systems approach as the theoretical base. It was rigorously developed in a Stage 1 treatment development study with substance use disordered homeless mothers who were engaged through a crisis shelter. EBT showed several outcomes superior to shelter services and is therefore considered a good fit for a population who avoids the shelter but is in great need of housing and support services. Two hundred forty (N = 240) substance use disordered homeless young women between the ages of 18 to 24 years with a biological child under the age of 6 years in their care will be randomly assigned to one of three conditions:
- housing and support services (EBT) + Treatment as Usual (TAU) (N = 80),
- housing only (HO) + TAU (N = 80), or
- TAU only (N=80).
EBT includes 6 months of supportive services (case management, HIV prevention and the Community Reinforcement Approach) in addition to 3 months of rental assistance. HO includes 3 months of rental assistance, but without supportive services. TAU is usual services offered by a homeless youth drop-in center. Participants will be re-assessed at 3, 6, 9 and 12 months post-baseline. Theoretically derived mediators of change as well as a formal economic evaluation will offer important policy implications. Since homeless substance use disordered mothers and their children are at increased risk for a variety of adverse outcomes, the intervention may produce substantial health-care benefits to their families and society at large.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Department of Human Development and Family Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- aged 18-24 years
- meets McKinney-Vento definition of homeless
- has physical custody of child under the age of 7
- meets DSM5 criteria for alcohol/drug use disorder
Exclusion Criteria:
- Evidence of unremitted psychosis or other condition which would impair mother's ability to understand or participate in the intervention or consent to the research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ecologically-Based Therapy + TAU
receives Ecologically-Based Therapy which includes the Community Reinforcement Approach, Strengths-Based Case Management (6 months) and rental assistance for housing (3 months) + TAU
|
6 months of community reinforcement approach and case management, 3 months of rental assistance for housing
receives services as normally offered within the community
|
|
Experimental: Housing Only + TAU
receives 3 months of rental assistance for housing only + TAU
|
receives services as normally offered within the community
receives 3 months of project supported rental assistance
|
|
Other: treatment as usual (TAU)
receives usual treatments/interventions (TAU) within in the community
|
receives services as normally offered within the community
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in substance use frequency
Time Frame: 12 months
|
frequency of substance use is measured at baseline, 3, 6, 9 and 12-months post-baseline
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in stable housing
Time Frame: 12 months
|
number of days in own apartment paying rent is measured at baseline, 3, 6, 9 and 12 months post-baseline
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014B0348
- R01DA023062 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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