Substance UseNCT02577666
Evaluation of EBT With Young, Substance Abusing Homeless Mothers
A study testing Ecologically Based Therapy, Housing Only and Treatment as Usual in people with Substance Use, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Ecologically Based Therapy, Housing Only and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Department of Human Development and Family Science
Columbus, Ohio, 43210
About this study
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.
Read the detailed description
Homeless mothers with young children in their care contend with high rates of substance use, HIV risk, physical and mental health problems and parenting stress. These struggles are in addition to homelessness and meeting the basic needs of themselves and their children. However, a very limited number of studies have examined mother and child outcomes associated with housing and supportive services. 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. A comprehensive intervention that can be offered outside the shelter setting may offer greater reach to those experiencing homelessness who do not make it in to the shelter system, and for those communities that do not have shelters available. Among the young homeless, those under age 25, research documents that the majority (70%) have never used shelter services. Research attention towards identifying efficacious interventions for this population which address the multiple needs of these families is thus considered an important focus. The proposed intervention (Ecologically-Based Treatment, EBT) includes housing and supportive services and utilizes an ecological systems approach as the theoretical base. It was rigorously developed in a Stage 1 treatment development study with substance use disordered homeless mothers who were engaged through a crisis shelter. EBT showed several outcomes superior to shelter services and is therefore considered a good fit for a population who avoids the shelter but is in great need of housing and support services. Two hundred forty (N = 240) substance use disordered homeless young women between the ages of 18 to 24 years with a biological child under the age of 6 years in their care will be randomly assigned to one of three conditions:
- housing and support services (EBT) + Treatment as Usual (TAU) (N = 80),
- housing only (HO) + TAU (N = 80), or
- TAU only (N=80).
EBT includes 6 months of supportive services (case management, HIV prevention and the Community Reinforcement Approach) in addition to 3 months of rental assistance. HO includes 3 months of rental assistance, but without supportive services. TAU is usual services offered by a homeless youth drop-in center. Participants will be re-assessed at 3, 6, 9 and 12 months post-baseline. Theoretically derived mediators of change as well as a formal economic evaluation will offer important policy implications. Since homeless substance use disordered mothers and their children are at increased risk for a variety of adverse outcomes, the intervention may produce substantial health-care benefits to their families and society at large.
- Conditions
- Substance Use
- Being tested
- Ecologically Based Therapy, Housing Only, Treatment as Usual
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecologically Based TherapyBehavioural
6 months of community reinforcement approach and case management, 3 months of rental assistance for housing
Housing OnlyBehavioural
receives 3 months of project supported rental assistance
Treatment as UsualBehavioural
receives services as normally offered within the community
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Ecologically Based Therapy; Behavioral: Treatment as Usual |
| Housing Only + TAU | Experimental | receives 3 months of rental assistance for housing only + TAU Receives: Behavioral: Housing Only; Behavioral: Treatment as Usual |
| treatment as usual (TAU) | Other | receives usual treatments/interventions (TAU) within in the community Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in substance use frequency
frequency of substance use is measured at baseline, 3, 6, 9 and 12-months post-baseline
Measured: 12 months
Secondary outcomes (1)
change in stable housing
number of days in own apartment paying rent is measured at baseline, 3, 6, 9 and 12 months post-baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2018
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Natasha Slesnick, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577666
- Sponsor's protocol ID
- 2014B0348
- Other IDs
- R01DA023062
- Status last verified
- Dec 2019
- First submitted
- 10 Oct 2015
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhang J, Slesnick N, Feng X. Housing intervention impacts on parenting stress and child problem behaviors among mothers experiencing homelessness. J Fam Psychol. 2026 Aug 31. doi: 10.1037/fam0001524. Online ahead of print.
PubMed 42671828
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of EBT With Young, Substance Abusing Homeless Mothers
- ClinicalTrials.gov ID
- NCT02577666
- Acronym / sponsor ID
- 2014B0348
- Conditions
- Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Homeless mothers with young children in their care contend with high rates of substance use, HIV risk, physical and mental health problems and parenting stress. These struggles are in addition to homelessness and meeting the basic needs of themselves and their children. However, a very limited number of studies have examined mother and child outcomes associated with housing and supportive services. 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. A comprehensive intervention that can be offered outside the shelter setting may offer greater reach to those experiencing homelessness who do not make it in to the shelter system, and for those communities that do not have shelters available. Among the young homeless, those under age 25, research documents that the majority (70%) have never used shelter services. Research attention towards identifying efficacious interventions for this population which address the multiple needs of these families is thus considered an important focus. The proposed intervention (Ecologically-Based Treatment, EBT) includes housing and supportive services and utilizes an ecological systems approach as the theoretical base. It was rigorously developed in a Stage 1 treatment development study with substance use disordered homeless mothers who were engaged through a crisis shelter. EBT showed several outcomes superior to shelter services and is therefore considered a good fit for a population who avoids the shelter but is in great need of housing and support services. Two hundred forty (N = 240) substance use disordered homeless young women between the ages of 18 to 24 years with a biological child under the age of 6 years in their care will be randomly assigned to one of three conditions:
- housing and support services (EBT) + Treatment as Usual (TAU) (N = 80),
- housing only (HO) + TAU (N = 80), or
- TAU only (N=80).
EBT includes 6 months of supportive services (case management, HIV prevention and the Community Reinforcement Approach) in addition to 3 months of rental assistance. HO includes 3 months of rental assistance, but without supportive services. TAU is usual services offered by a homeless youth drop-in center. Participants will be re-assessed at 3, 6, 9 and 12 months post-baseline. Theoretically derived mediators of change as well as a formal economic evaluation will offer important policy implications. Since homeless substance use disordered mothers and their children are at increased risk for a variety of adverse outcomes, the intervention may produce substantial health-care benefits to their families and society at large.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ecologically-Based Therapy + TAU | Experimental | Behavioral: Ecologically Based Therapy, Behavioral: Treatment as Usualreceives Ecologically-Based Therapy which includes the Community Reinforcement Approach, Strengths-Based Case Management (6 months) and rental assistance for housing (3 months) + TAU |
| Housing Only + TAU | Experimental | Behavioral: Housing Only, Behavioral: Treatment as Usualreceives 3 months of rental assistance for housing only + TAU |
| treatment as usual (TAU) | Other | Behavioral: Treatment as Usualreceives usual treatments/interventions (TAU) within in the community |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecologically Based Therapy6 months of community reinforcement approach and case management, 3 months of rental assistance for housing | Behavioural | Ecologically-Based Therapy + TAU |
| Housing Onlyreceives 3 months of project supported rental assistance | Behavioural | Housing Only + TAU |
| Treatment as Usualreceives services as normally offered within the community | Behavioural | Ecologically-Based Therapy + TAU, Housing Only + TAU, treatment as usual (TAU) |
Primary outcome
Change in substance use frequency
Time frame: 12 months
frequency of substance use is measured at baseline, 3, 6, 9 and 12-months post-baseline
1 secondary outcome
change in stable housing
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Derived from this study: PubMed 42671828Zhang J, Slesnick N, Feng X. Housing intervention impacts on parenting stress and child problem behaviors among mothers experiencing homelessness. J Fam Psychol. 2026 Aug 31. doi: 10.1037/fam0001524. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Substance Use
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecologically Based Therapy, Housing Only and Treatment as Usual in people with Substance Use, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in substance use frequency (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02577666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.