Stage 1 Treatment Development With Homeless Mothers

Substance Abuse Clinical Trial

Official title:

Stage 1 Treatment Development With Homeless Mothers and Their 2-6 Year Old Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193114
• Other study ID #: 2008B0309
• Secondary ID: R01DA023908
• Status: Completed
• Phase: N/A
• First received: February 2, 2010
• Last updated: January 26, 2013
• Start date: April 2009
• Est. completion date: February 2012

Study information

• Verified date: January 2013
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Abuse

Intervention

Behavioral:
• Ecologically Based Treatment (EBT)
Substance abuse treatment (the Community Reinforcement Approach), case management and housing.
• Treatment as Usual (TAU)
Treatment/intervention as normally provided by community service agencies that service substance abusing homeless families.

Locations

Country	Name	City	State
United States	The Ohio State University Department of Human Development and Family Science	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Days of Substance Use in the Prior 3 Months.		3 months post-baseline measure	No
Primary	Percent Days of Substance Use in the Prior 3 Months.		6 months post-baseline measure	No
Primary	Percent Days of Substance Use in the Prior 3 Months.		9 months post-baseline measure	No
Secondary	BDI Depression Score	Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)	3 months post-baseline measure	No
Secondary	BDI Depression Score	Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)	6 months post-baseline measure	No
Secondary	BDI Depression Score	Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)	9 months post-baseline measure	No