SET-Recovery/Healthy Home

Substance-Related Disorders Clinical Trial

— SET-R  

Official title:

Set-Enhanced Aftercare for Mothers in Substance Abuse Recovery and Their Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702193
• Other study ID #: 20111132
• Secondary ID: U54MD002266
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: August 2017

Study information

• Verified date: November 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 4, 8 and 12 months
Primary	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.	baseline, 4, 8 and 12 months
Secondary	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.	baseline, 4, 8 and 12 months
Secondary	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.	baseline, 4, 8 and 12 months
Secondary	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.	baseline, 4, 8 and 12 months
Secondary	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.	baseline, 4, 8 and 12 months
Secondary	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.	baseline, 4, 8 and 12 months
Secondary	Trajectory of Daily Smoking of Participants	Self-reported Daily Smoking as measured by the Addiction Severity Index.	baseline, 4, 8 and 12 months
Secondary	Trajectory of Alcohol Intoxication of Participants	Self-reported Alcohol Intoxication as measured by the Addiction Severity Index.	baseline, 4, 8 and 12 months
Secondary	Trajectory of Illicit Drug Use of Participants	Self-reported Illicit Drug Use as measured by the Addiction Severity Index.	baseline, 4, 8 and 12 months