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SET-Recovery/Healthy Home (SET-R)

Primary Purpose

Substance-Related Disorders, Mental Health

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SET-R/Healthy Home
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance-Related Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Enrolled in outpatient substance abuse or mental health treatment (or treatment for substance abuse as a co-occurring disorder) or case management for mental health or substance abuse problems,
  2. have at least one child age 0-17 with whom she has at least monthly contact
  3. be age 18 or above,
  4. capable of giving informed consent and comprehending either English or Spanish,
  5. willing and able to participate fully in the protocol

Exclusion Criteria:

Persons who do not meet the inclusion criteria listed above will be excluded.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SET-R/Healthy Home

TAU

Arm Description

SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers.

Treatment as usual - the usual outpatient substance abuse or mental health services received by the mothers with no additional services provided by the study team.

Outcomes

Primary Outcome Measures

Trajectory of Depression of Participants
Self-reported experience with depressive symptoms as measured by the PROMIS depression scale over the past 7 days. Each item is scored 1-5 (1 = Never; 5 = Always), yielding a total between 8 and 40.
Trajectory of Anxiety of Participants
Self-reported experience with anxiety symptoms as measured by the PROMIS anxiety scale over the past 7 days. Each item is scored 1-5 (1 = Never; 5 = Always), yielding a total between 8 and 40.

Secondary Outcome Measures

Trajectory of Sleep Disturbance of Participants
Self-reported experience with sleep disturbance over the past 7 days as measured by the PROMIS 29 sleep disturbance subscale . Each item is scored 1-5, yielding a total between 4 and 20.
Trajectory of Fatigue of Participants
Self-reported experience with fatigue over the past 7 days as measured by the PROMIS 29 fatigue subscale. Each item is scored 1-5, yielding a total between 5 and 20.
Trajectory of Pain Experienced by Participants
Self-reported experience with pain over the past 7 days as measured by the PROMIS 29 pain subscale. Each item is scored 1-5, yielding a total between 5 and 25.
Trajectory of Physical Function of Participants
Self-reported physical function over the past 7 days as measured by the PROMIS 29 physical function subscale. Each item is scored 1-5, yielding a total between 4 and 20, with higher scores indicating better physical function.
Trajectory of Oral Health Problems of Participants
Self-reported oral health as measured by the Oral Health Impact Profile. Each item is scored 1-5, yielding a total between 14 and 70.
Trajectory of Daily Smoking of Participants
Self-reported Daily Smoking as measured by the Addiction Severity Index.
Trajectory of Alcohol Intoxication of Participants
Self-reported Alcohol Intoxication as measured by the Addiction Severity Index.
Trajectory of Illicit Drug Use of Participants
Self-reported Illicit Drug Use as measured by the Addiction Severity Index.

Full Information

First Posted
March 2, 2016
Last Updated
November 30, 2018
Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02702193
Brief Title
SET-Recovery/Healthy Home
Acronym
SET-R
Official Title
Set-Enhanced Aftercare for Mothers in Substance Abuse Recovery and Their Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study conducts a community-based randomized trial comparing an adaptation of Structural Ecosystems Therapy (SET), "Healthy Home", as an enhancement of substance abuse or mental health outpatient treatment, to outpatient treatment as usual (TAU) among approximately 172 Black, Hispanic and White nonHispanic mothers enrolled in outpatient substance abuse or mental health services. The study is conducted with a community partner, Banyan Health Systems, that delivers substance abuse/mental health treatment and primary care. Data is collected at baseline and 4, 8, and 12 months postrandomization. The Specific Aims of the proposed study are to: 1) test the effectiveness of Healthy Home for improving physical and mental health and reducing relapse of mothers in substance abuse/mental health recovery; 2) test the effectiveness of Healthy Home for improving health and mental health outcomes of children of mothers in recovery; 3) test mechanisms of action of Healthy Home (self care, environmental risk, family functioning and stigma); 4) assess implementation and sustainability factors and the relationship between fidelity and outcomes; and 5) examine the interactions of ethnicity and ethnicity related factors on outcomes. Healthy Home is a manualized, strength-based, directive and process oriented family ecosystemic home health intervention developed to address the needs of mothers and their children affected by substance abuse and other mental health disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Mental Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SET-R/Healthy Home
Arm Type
Experimental
Arm Description
SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers.
Arm Title
TAU
Arm Type
No Intervention
Arm Description
Treatment as usual - the usual outpatient substance abuse or mental health services received by the mothers with no additional services provided by the study team.
Intervention Type
Behavioral
Intervention Name(s)
SET-R/Healthy Home
Intervention Description
SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.
Primary Outcome Measure Information:
Title
Trajectory of Depression of Participants
Description
Self-reported experience with depressive symptoms as measured by the PROMIS depression scale over the past 7 days. Each item is scored 1-5 (1 = Never; 5 = Always), yielding a total between 8 and 40.
Time Frame
baseline, 4, 8 and 12 months
Title
Trajectory of Anxiety of Participants
Description
Self-reported experience with anxiety symptoms as measured by the PROMIS anxiety scale over the past 7 days. Each item is scored 1-5 (1 = Never; 5 = Always), yielding a total between 8 and 40.
Time Frame
baseline, 4, 8 and 12 months
Secondary Outcome Measure Information:
Title
Trajectory of Sleep Disturbance of Participants
Description
Self-reported experience with sleep disturbance over the past 7 days as measured by the PROMIS 29 sleep disturbance subscale . Each item is scored 1-5, yielding a total between 4 and 20.
Time Frame
baseline, 4, 8 and 12 months
Title
Trajectory of Fatigue of Participants
Description
Self-reported experience with fatigue over the past 7 days as measured by the PROMIS 29 fatigue subscale. Each item is scored 1-5, yielding a total between 5 and 20.
Time Frame
baseline, 4, 8 and 12 months
Title
Trajectory of Pain Experienced by Participants
Description
Self-reported experience with pain over the past 7 days as measured by the PROMIS 29 pain subscale. Each item is scored 1-5, yielding a total between 5 and 25.
Time Frame
baseline, 4, 8 and 12 months
Title
Trajectory of Physical Function of Participants
Description
Self-reported physical function over the past 7 days as measured by the PROMIS 29 physical function subscale. Each item is scored 1-5, yielding a total between 4 and 20, with higher scores indicating better physical function.
Time Frame
baseline, 4, 8 and 12 months
Title
Trajectory of Oral Health Problems of Participants
Description
Self-reported oral health as measured by the Oral Health Impact Profile. Each item is scored 1-5, yielding a total between 14 and 70.
Time Frame
baseline, 4, 8 and 12 months
Title
Trajectory of Daily Smoking of Participants
Description
Self-reported Daily Smoking as measured by the Addiction Severity Index.
Time Frame
baseline, 4, 8 and 12 months
Title
Trajectory of Alcohol Intoxication of Participants
Description
Self-reported Alcohol Intoxication as measured by the Addiction Severity Index.
Time Frame
baseline, 4, 8 and 12 months
Title
Trajectory of Illicit Drug Use of Participants
Description
Self-reported Illicit Drug Use as measured by the Addiction Severity Index.
Time Frame
baseline, 4, 8 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Enrolled in outpatient substance abuse or mental health treatment (or treatment for substance abuse as a co-occurring disorder) or case management for mental health or substance abuse problems, have at least one child age 0-17 with whom she has at least monthly contact be age 18 or above, capable of giving informed consent and comprehending either English or Spanish, willing and able to participate fully in the protocol Exclusion Criteria: Persons who do not meet the inclusion criteria listed above will be excluded.
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The researcher will abide by NIH standards for sharing research resources developed through the study. Data will be made available no later than the date when the main findings are published. Upon request, electronic copies will be provided to researchers, along with data documentation. Data will not contain any personal identifiers. Researchers using these data will be asked to sign a data sharing agreement approved by the University of Miami. The primary purpose of this agreement will be to ensure that researchers using the dataset are aware of the potential risks to vulnerable groups, and take adequate protective steps.
Citations:
PubMed Identifier
21171773
Citation
Mitrani VB, McCabe BE, Robinson C, Weiss-Laxer NS, Feaster DJ. Structural Ecosystems Therapy for recovering HIV-positive women: child, mother, and parenting outcomes. J Fam Psychol. 2010 Dec;24(6):746-55. doi: 10.1037/a0021638.
Results Reference
background
PubMed Identifier
20594207
Citation
Feaster DJ, Burns MJ, Brincks AM, Prado G, Mitrani VB, Mauer MH, Szapocznik J. Structural Ecosystems Therapy for HIV+ African-American women and drug abuse relapse. Fam Process. 2010 Jun;49(2):204-19. doi: 10.1111/j.1545-5300.2010.01318.x.
Results Reference
background
PubMed Identifier
20538417
Citation
Feaster DJ, Mitrani VB, Burns MJ, McCabe BE, Brincks AM, Rodriguez AE, Asthana D, Robbins MS. A randomized controlled trial of Structural Ecosystems Therapy for HIV medication adherence and substance abuse relapse prevention. Drug Alcohol Depend. 2010 Oct 1;111(3):227-34. doi: 10.1016/j.drugalcdep.2010.04.017. Epub 2010 Jun 9.
Results Reference
background
PubMed Identifier
32102585
Citation
Matsuda Y, McCabe BE, Behar-Zusman V. Mothering in the Context of Mental Disorder: Effect of Caregiving Load on Maternal Health in a Predominantly Hispanic Sample. J Am Psychiatr Nurses Assoc. 2021 Sep-Oct;27(5):373-382. doi: 10.1177/1078390320907693. Epub 2020 Feb 26.
Results Reference
derived

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SET-Recovery/Healthy Home

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