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Evaluation of EBT With Young, Substance Abusing Homeless Mothers

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ecologically Based Therapy
Housing Only
Treatment as Usual
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use

Eligibility Criteria

18 Years - 24 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • The Ohio State University Department of Human Development and Family Science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Ecologically-Based Therapy + TAU

Housing Only + TAU

treatment as usual (TAU)

Arm Description

receives Ecologically-Based Therapy which includes the Community Reinforcement Approach, Strengths-Based Case Management (6 months) and rental assistance for housing (3 months) + TAU

receives 3 months of rental assistance for housing only + TAU

receives usual treatments/interventions (TAU) within in the community

Outcomes

Primary Outcome Measures

Change in substance use frequency
frequency of substance use is measured at baseline, 3, 6, 9 and 12-months post-baseline

Secondary Outcome Measures

change in stable housing
number of days in own apartment paying rent is measured at baseline, 3, 6, 9 and 12 months post-baseline

Full Information

First Posted
October 10, 2015
Last Updated
December 20, 2019
Sponsor
Ohio State University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02577666
Brief Title
Evaluation of EBT With Young, Substance Abusing Homeless Mothers
Official Title
Evaluation of EBT With Young, Substance Abusing Homeless Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A dearth of information is available regarding how best to intervene with substance use disordered homeless mothers and their young children. This proposal follows from the promising findings of a rigorously developed ecologically based treatment that offers a comprehensive intervention for the multiple needs of this vulnerable population. Such research attention is needed in order to effectively intervene in the substance use, HIV risk, mental/physical health and homeless trajectory of these women and their young children. Further, if successful, this intervention may be transportable to communities without crisis shelters and to homeless mothers who do not access shelter or residential treatment services.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ecologically-Based Therapy + TAU
Arm Type
Experimental
Arm Description
receives Ecologically-Based Therapy which includes the Community Reinforcement Approach, Strengths-Based Case Management (6 months) and rental assistance for housing (3 months) + TAU
Arm Title
Housing Only + TAU
Arm Type
Experimental
Arm Description
receives 3 months of rental assistance for housing only + TAU
Arm Title
treatment as usual (TAU)
Arm Type
Other
Arm Description
receives usual treatments/interventions (TAU) within in the community
Intervention Type
Behavioral
Intervention Name(s)
Ecologically Based Therapy
Intervention Description
6 months of community reinforcement approach and case management, 3 months of rental assistance for housing
Intervention Type
Behavioral
Intervention Name(s)
Housing Only
Intervention Description
receives 3 months of project supported rental assistance
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
receives services as normally offered within the community
Primary Outcome Measure Information:
Title
Change in substance use frequency
Description
frequency of substance use is measured at baseline, 3, 6, 9 and 12-months post-baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
change in stable housing
Description
number of days in own apartment paying rent is measured at baseline, 3, 6, 9 and 12 months post-baseline
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The Ohio State University Department of Human Development and Family Science
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of EBT With Young, Substance Abusing Homeless Mothers

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