MedDataX Logo

Evaluation of EBT With Young, Substance Abusing Homeless Mothers

NCT ID: NCT02577666

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Substance Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Ecologically Based Therapy

Intervention Type BEHAVIORAL

6 months of community reinforcement approach and case management, 3 months of rental assistance for housing

Treatment as Usual

Intervention Type BEHAVIORAL

receives services as normally offered within the community

Housing Only + TAU

receives 3 months of rental assistance for housing only + TAU

Group Type EXPERIMENTAL

Housing Only

Intervention Type BEHAVIORAL

receives 3 months of project supported rental assistance

Treatment as Usual

Intervention Type BEHAVIORAL

receives services as normally offered within the community

treatment as usual (TAU)

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

Group Type OTHER

Treatment as Usual

Intervention Type BEHAVIORAL

receives services as normally offered within the community

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ecologically Based Therapy

6 months of community reinforcement approach and case management, 3 months of rental assistance for housing

Intervention Type BEHAVIORAL

Housing Only

receives 3 months of project supported rental assistance

Intervention Type BEHAVIORAL

Treatment as Usual

receives services as normally offered within the community

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Natasha Slesnick

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ohio State University Department of Human Development and Family Science

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DA023062

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014B0348

Identifier Type: -

Identifier Source: org_study_id