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Stage 1 Treatment Development With Homeless Mothers

Primary Purpose

Substance Abuse

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

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring substance abuse, homeless mothers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • residing at a homeless shelter for families
  • meet diagnostic criteria for psychoactive substance use or alcohol disorder
  • has physical custody of a biological child between the ages of 2 to 6 years old

Exclusion Criteria:

  • evidence of unremitted psychosis or other condition that would impair the mothers' ability to understand and participate in the intervention research.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ecologically-Based Behavioral Treatment

Treatment as Usual

Arm Description

Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.

The Mothers were offered services provided through the family shelter.

Outcomes

Primary Outcome Measures

Percent Days of Substance Use in the Prior 3 Months.
Percent Days of Substance Use in the Prior 3 Months.
Percent Days of Substance Use in the Prior 3 Months.

Secondary Outcome Measures

BDI Depression Score
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
BDI Depression Score
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
BDI Depression Score
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)

Full Information

First Posted
February 2, 2010
Last Updated
January 26, 2013
Sponsor
Ohio State University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01193114
Brief Title
Stage 1 Treatment Development With Homeless Mothers
Official Title
Stage 1 Treatment Development With Homeless Mothers and Their 2-6 Year Old Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (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
Aim 1. Identify specific targets and processes of intervention among homeless substance abusing mothers with children between the ages of 2 and 6 years from information collected in focus groups and assessment interviews. Translate that information for the refinement of the ecologically based treatment manual. Aim 2. Test the efficacy of the treatment in a nonrandomized pilot study and revise the manual based upon those findings. Aim 3. Test the efficacy of the experimental intervention compared to treatment as usual (TAU) in a randomized pilot, with the goal to improve maternal substance abuse problems, social stability, and mental health. It is expected that the experimental intervention will be associated with lower substance use and related problem behaviors than TAU. Aim 4. Test whether intended change processes (mediators) associated with the intervention produce the desired change in mother's substance use, social stability, and mental health. It is expected that self-efficacy will mediate substance use outcomes. Aim 5. Explore how length of homelessness, age and ethnicity of the mother predict treatment response (moderators). Aim 6. Explore the impact of the experimental intervention (Ecologically-Based Therapy)on interpersonal stress and child's mental health.
Detailed Description
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. The majority of these families are headed by single mothers, many of whom struggle with substance use and mental health issues. These struggles are in addition to meeting the basic needs of themselves and their children. No study has documented an effective approach for intervening with homeless substance abusing mothers with children. Research attention towards identifying efficacious interventions for this population which address the multiple needs of these families is thus considered an important focus for reducing significant individual and social costs associated with substance use and homelessness. The current study utilizes an ecological systems approach as the theoretical base for the proposed treatment. The overarching goals of the current treatment development study are to first identify targets and processes of intervention desired by homeless mothers and then pilot test a novel manualized intervention focused on improving treatment success of this special population. In Stage 1a, information from the multi-method assessment and focus groups with N=30 homeless mothers will guide modifications to an integrated intervention that includes housing, case management and the Community Reinforcement Approach. The final manual resulting from this important study will address the multiple needs of homeless mothers, including basic needs and substance use/mental health problems. The intervention will be tested in a nonrandomized pilot (N = 15) in which interview and self-report methods will be used for data gathering. Follow-up will be conducted at 3 and 6 months post baseline and the intervention will be modified based upon the process and outcome analyses. Finally, the revised intervention will be tested in Stage 1b in a randomized pilot study involving 60 women and children assigned to the project intervention (N = 30) or treatment as usual (N=30) and followed at 3, 6, and 9 months post-baseline. In the randomized pilot study an effect size will be computed for use in informing a larger, randomized Stage II trial. This project utilizes existing efficacious models of drug abuse treatment to generate valuable new information critical to treatment services delivery for a special population of substance abusers. Since homeless substance abusing women and their children are at increased risk for a variety of adverse outcomes, improved maternal and child outcomes may produce substantial health-care benefits to the women, their children, and society at large. The findings from this study will serve as the foundation for the refinement and implementation of a promising intervention for drug-addicted homeless women and children that can then be tested for efficacy in a Stage II trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
substance abuse, homeless mothers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ecologically-Based Behavioral Treatment
Arm Type
Experimental
Arm Description
Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
The Mothers were offered services provided through the family shelter.
Intervention Type
Behavioral
Intervention Name(s)
Ecologically Based Treatment (EBT)
Intervention Description
Substance abuse treatment (the Community Reinforcement Approach), case management and housing.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
Treatment/intervention as normally provided by community service agencies that service substance abusing homeless families.
Primary Outcome Measure Information:
Title
Percent Days of Substance Use in the Prior 3 Months.
Time Frame
3 months post-baseline measure
Title
Percent Days of Substance Use in the Prior 3 Months.
Time Frame
6 months post-baseline measure
Title
Percent Days of Substance Use in the Prior 3 Months.
Time Frame
9 months post-baseline measure
Secondary Outcome Measure Information:
Title
BDI Depression Score
Description
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
Time Frame
3 months post-baseline measure
Title
BDI Depression Score
Description
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
Time Frame
6 months post-baseline measure
Title
BDI Depression Score
Description
Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
Time Frame
9 months post-baseline measure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: residing at a homeless shelter for families meet diagnostic criteria for psychoactive substance use or alcohol disorder has physical custody of a biological child between the ages of 2 to 6 years old Exclusion Criteria: evidence of unremitted psychosis or other condition that would impair the mothers' ability to understand and participate in the intervention research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natasha Slesnick, Ph.D.
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
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

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Stage 1 Treatment Development With Homeless Mothers

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