NCT02577666

Brief Summary

A dearth of information is available regarding how best to intervene with substance use disordered homeless mothers and their young children. This proposal follows from the promising findings of a rigorously developed ecologically based treatment that offers a comprehensive intervention for the multiple needs of this vulnerable population. Such research attention is needed in order to effectively intervene in the substance use, HIV risk, mental/physical health and homeless trajectory of these women and their young children. Further, if successful, this intervention may be transportable to communities without crisis shelters and to homeless mothers who do not access shelter or residential treatment services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 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

February 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

3.7 years

First QC Date

October 10, 2015

Last Update Submit

December 20, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in substance use frequency

    frequency of substance use is measured at baseline, 3, 6, 9 and 12-months post-baseline

    12 months

Secondary Outcomes (1)

  • change in stable housing

    12 months

Study Arms (3)

Ecologically-Based Therapy + TAU

EXPERIMENTAL

receives Ecologically-Based Therapy which includes the Community Reinforcement Approach, Strengths-Based Case Management (6 months) and rental assistance for housing (3 months) + TAU

Behavioral: Ecologically Based TherapyBehavioral: Treatment as Usual

Housing Only + TAU

EXPERIMENTAL

receives 3 months of rental assistance for housing only + TAU

Behavioral: Housing OnlyBehavioral: Treatment as Usual

treatment as usual (TAU)

OTHER

receives usual treatments/interventions (TAU) within in the community

Behavioral: Treatment as Usual

Interventions

6 months of community reinforcement approach and case management, 3 months of rental assistance for housing

Ecologically-Based Therapy + TAU
Housing OnlyBEHAVIORAL

receives 3 months of project supported rental assistance

Housing Only + TAU

receives services as normally offered within the community

Ecologically-Based Therapy + TAUHousing Only + TAUtreatment as usual (TAU)

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18-24 years
  • meets McKinney-Vento definition of homeless
  • has physical custody of child under the age of 7
  • meets DSM5 criteria for alcohol/drug use disorder

You may not qualify if:

  • Evidence of unremitted psychosis or other condition which would impair mother's ability to understand or participate in the intervention or consent to the 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2015

First Posted

October 16, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 30, 2019

Last Updated

December 24, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations