N/A Completed N=60 Randomized Treatment

Stage 1 Treatment Development With Homeless Mothers

Substance Abuse

Source: ClinicalTrials.gov NCT01193114 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcomePrimary: Percent Days of Substance Use in the Prior 3 Months. — 45.40; 49.17 percent days of substance use

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Days of Substance Use in the Prior 3 Months.	41.74; 44.54	—
SECONDARY BDI Depression Score	13.21; 13.38	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01193114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.