Evaluation of EBT With Young, Substance Abusing Homeless Mothers

December 20, 2019 updated by: Natasha Slesnick, Ohio State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Department of Human Development and Family Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: Ecologically Based Therapy
6 months of community reinforcement approach and case management, 3 months of rental assistance for housing
Behavioral: Treatment as Usual
receives services as normally offered within the community
Experimental: Housing Only + TAU
receives 3 months of rental assistance for housing only + TAU
Behavioral: Treatment as Usual
receives services as normally offered within the community
Behavioral: Housing Only
receives 3 months of project supported rental assistance
Other: treatment as usual (TAU)
receives usual treatments/interventions (TAU) within in the community
Behavioral: Treatment as Usual
receives services as normally offered within the community

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014B0348
  • R01DA023062 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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