Stage 1 Treatment Development With Homeless Mothers
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|ClinicalTrials.gov Identifier: NCT01193114|
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : March 1, 2013
Last Update Posted : March 1, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Substance Abuse||Behavioral: Ecologically Based Treatment (EBT) Behavioral: Treatment as Usual (TAU)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stage 1 Treatment Development With Homeless Mothers and Their 2-6 Year Old Children|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Experimental: Ecologically-Based Behavioral Treatment
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)
Substance abuse treatment (the Community Reinforcement Approach), case management and housing.
Active Comparator: Treatment as Usual
The Mothers were offered services provided through the family shelter.
Behavioral: Treatment as Usual (TAU)
Treatment/intervention as normally provided by community service agencies that service substance abusing homeless families.
- Percent Days of Substance Use in the Prior 3 Months. [ Time Frame: 3 months post-baseline measure ]
- Percent Days of Substance Use in the Prior 3 Months. [ Time Frame: 6 months post-baseline measure ]
- Percent Days of Substance Use in the Prior 3 Months. [ Time Frame: 9 months post-baseline measure ]
- BDI Depression Score [ Time Frame: 3 months post-baseline measure ]Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
- BDI Depression Score [ Time Frame: 6 months post-baseline measure ]Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
- BDI Depression Score [ Time Frame: 9 months post-baseline measure ]Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193114
|United States, Ohio|
|The Ohio State University Department of Human Development and Family Science|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Natasha Slesnick, Ph.D.||Ohio State University|