NCT01193114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 1, 2013

Completed
Last Updated

March 1, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

February 2, 2010

Results QC Date

December 13, 2012

Last Update Submit

January 26, 2013

Conditions

Substance Abuse

Keywords

substance abusehomeless mothers

Outcome Measures

Primary Outcomes (3)

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

    3 months post-baseline measure

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

    6 months post-baseline measure

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

    9 months post-baseline measure

Secondary Outcomes (3)

  • BDI Depression Score

    3 months post-baseline measure

  • BDI Depression Score

    6 months post-baseline measure

  • BDI Depression Score

    9 months post-baseline measure

Study Arms (2)

Ecologically-Based Behavioral Treatment

EXPERIMENTAL

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.

Behavioral: Ecologically Based Treatment (EBT)

Treatment as Usual

ACTIVE COMPARATOR

The Mothers were offered services provided through the family shelter.

Behavioral: Treatment as Usual (TAU)

Interventions

Ecologically Based Treatment (EBT)BEHAVIORAL

Substance abuse treatment (the Community Reinforcement Approach), case management and housing.

Ecologically-Based Behavioral Treatment
Treatment as Usual (TAU)BEHAVIORAL

Treatment/intervention as normally provided by community service agencies that service substance abusing homeless families.

Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Department of Human Development and Family Science

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Natasha Slesnick
Organization
The Ohio State University
slesnick.5@osu.edu
614 247-8469

Study Officials

  • Natasha Slesnick, Ph.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 2, 2010

First Posted

September 1, 2010

Study Start

April 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 1, 2013

Results First Posted

March 1, 2013

Record last verified: 2013-01

Locations

US(1)