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Substance AbuseNCT01193114

Stage 1 Treatment Development With Homeless Mothers

A study testing Ecologically Based Treatment (EBT) and Treatment as Usual (TAU) in people with Substance Abuse, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Substance Abuse
What is being tested?
Ecologically Based Treatment (EBT) and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Apr 2009to Feb 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • evidence of unremitted psychosis or other condition that would impair the mothers' ability to understand and participate in the intervention 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

Other trials in United States

About this study

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

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.

Read more

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.

Read the detailed 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.

Conditions
Substance Abuse
Being tested
Ecologically Based Treatment (EBT), Treatment as Usual (TAU)
Keywords
substance abuse, homeless mothers
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 Treatment (EBT)Behavioural

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

  • Treatment as Usual (TAU)Behavioural

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

Study groups in NCT01193114
Study groupRoleWhat they receive
Ecologically-Based Behavioral TreatmentExperimentalEcologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
Receives: Behavioral: Ecologically Based Treatment (EBT)
Treatment as UsualActive comparatorThe Mothers were offered services provided through the family shelter.
Receives: Behavioral: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Days of Substance Use in the Prior 3 Months.

    Measured: 3 months post-baseline measure

  2. Percent Days of Substance Use in the Prior 3 Months.

    Measured: 6 months post-baseline measure

  3. Percent Days of Substance Use in the Prior 3 Months.

    Measured: 9 months post-baseline measure

Secondary outcomes (3)
  1. BDI Depression Score

    Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)

    Measured: 3 months post-baseline measure

  2. BDI Depression Score

    Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)

    Measured: 6 months post-baseline measure

  3. BDI Depression Score

    Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)

    Measured: 9 months post-baseline measure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

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
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01193114
Sponsor's protocol ID
2008B0309
Other IDs
R01DA023908
Status last verified
Jan 2013
First submitted
2 Feb 2010
Last updated
1 Mar 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Ecologically Based Treatment (EBT) and Treatment as Usual (TAU) in people with Substance Abuse, 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 3 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 1 Mar 2013. 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?

Yes. Results are posted in the registry (first posted 1 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Days of Substance Use in the Prior 3 Months. (time frame: 3 months post-baseline measure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 Mar 2013.

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