SET-Recovery/Healthy Home (SET-R)

• ClinicalTrials.gov Identifier: NCT02702193
• Recruitment Status: Completed
• First Posted: March 8, 2016
• Results First Posted: December 20, 2018
• Last Update Posted: December 20, 2018
• Sponsor: University of Miami
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Victoria Mitrani, University of Miami

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.

Condition or disease	Intervention/treatment	Phase
Substance-Related Disorders; Mental Health	Behavioral: SET-R/Healthy Home	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 173 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Set-Enhanced Aftercare for Mothers in Substance Abuse Recovery and Their Children
• Actual Study Start Date: July 2013
• Actual Primary Completion Date: August 2017
• Actual Study Completion Date: August 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: SET-R/Healthy Home; 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.	Behavioral: SET-R/Healthy Home; 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.
No Intervention: TAU; 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.

Outcome Measures

Primary Outcome Measures :

1. Trajectory of Depression of Participants [ Time Frame: baseline, 4, 8 and 12 months ]
   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.
2. Trajectory of Anxiety of Participants [ Time Frame: baseline, 4, 8 and 12 months ]
   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 :

1. Trajectory of Sleep Disturbance of Participants [ Time Frame: baseline, 4, 8 and 12 months ]
   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.
2. Trajectory of Fatigue of Participants [ Time Frame: baseline, 4, 8 and 12 months ]
   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.
3. Trajectory of Pain Experienced by Participants [ Time Frame: baseline, 4, 8 and 12 months ]
   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.
4. Trajectory of Physical Function of Participants [ Time Frame: baseline, 4, 8 and 12 months ]
   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.
5. Trajectory of Oral Health Problems of Participants [ Time Frame: baseline, 4, 8 and 12 months ]
   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.
6. Trajectory of Daily Smoking of Participants [ Time Frame: baseline, 4, 8 and 12 months ]
   Self-reported Daily Smoking as measured by the Addiction Severity Index.
7. Trajectory of Alcohol Intoxication of Participants [ Time Frame: baseline, 4, 8 and 12 months ]
   Self-reported Alcohol Intoxication as measured by the Addiction Severity Index.
8. Trajectory of Illicit Drug Use of Participants [ Time Frame: baseline, 4, 8 and 12 months ]
   Self-reported Illicit Drug Use as measured by the Addiction Severity Index.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Florida

University of Miami

Miami, Florida, United States, 33146

Sponsors and Collaborators

University of Miami

National Institute on Minority Health and Health Disparities (NIMHD)

  Study Documents (Full-Text)

Documents provided by Victoria Mitrani, University of Miami:

Study Protocol and Statistical Analysis Plan  [PDF] June 7, 2016

More Information

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Victoria Mitrani, Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT02702193
• Other Study ID Numbers: 20111132; U54MD002266 ( U.S. NIH Grant/Contract )
• First Posted: March 8, 2016
• Results First Posted: December 20, 2018
• Last Update Posted: December 20, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders