Evaluation of EBT With Young, Substance Abusing Homeless Mothers

Substance Use Clinical Trial

Official title:

Evaluation of EBT With Young, Substance Abusing Homeless Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577666
• Other study ID #: 2014B0348
• Secondary ID: R01DA023062
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: October 30, 2019

Study information

• Verified date: December 2019
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. housing and support services (EBT) + Treatment as Usual (TAU) (N = 80),

2. housing only (HO) + TAU (N = 80), or

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 30, 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use

Intervention

Behavioral:
• Ecologically Based Therapy
6 months of community reinforcement approach and case management, 3 months of rental assistance for housing
• Housing Only
receives 3 months of project supported rental assistance
• Treatment as Usual
receives services as normally offered within the community

Locations

Country	Name	City	State
United States	The Ohio State University Department of Human Development and Family Science	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in substance use frequency	frequency of substance use is measured at baseline, 3, 6, 9 and 12-months post-baseline	12 months
Secondary	change in stable housing	number of days in own apartment paying rent is measured at baseline, 3, 6, 9 and 12 months post-baseline	12 months