Clinical trial NCT02702193: SET-Recovery/Healthy Home
Official title: Set-Enhanced Aftercare for Mothers in Substance Abuse Recovery and Their Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Mental Health
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2016-03-08
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Trajectory of Depression of Participants
timeFrame: baseline, 4, 8 and 12 months
measure: Trajectory of Anxiety of Participants
timeFrame: baseline, 4, 8 and 12 months
Secondary outcomes:
measure: Trajectory of Sleep Disturbance of Participants
timeFrame: baseline, 4, 8 and 12 months
measure: Trajectory of Fatigue of Participants
timeFrame: baseline, 4, 8 and 12 months
measure: Trajectory of Pain Experienced by Participants
timeFrame: baseline, 4, 8 and 12 months
measure: Trajectory of Physical Function of Participants
timeFrame: baseline, 4, 8 and 12 months
measure: Trajectory of Oral Health Problems of Participants
timeFrame: baseline, 4, 8 and 12 months
measure: Trajectory of Daily Smoking of Participants
timeFrame: baseline, 4, 8 and 12 months
measure: Trajectory of Alcohol Intoxication of Participants
timeFrame: baseline, 4, 8 and 12 months
measure: Trajectory of Illicit Drug Use of Participants
timeFrame: baseline, 4, 8 and 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
References:
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.
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.
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.
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.