CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Ecologically Based Treatment (EBT) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01193114
NCT01193114N/ACompleted

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

Ohio State University·interventional·Posted Sep 1, 2010·Updated Mar 1, 2013

In Brief

A clinical study evaluating Ecologically Based Treatment (EBT) and Treatment as Usual (TAU) for Substance Abuse. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubstance Abuse
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 1, 2010
Enrollment StartApr 1, 2009
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.8 years ago

Interventions

Ecologically Based Treatment (EBT)behavioral

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

Treatment as Usual (TAU)behavioral

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