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Completed

NCT Number: NCT02702193

SET-Recovery/Healthy Home

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.

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Key information

Conditions

Substance-related Disorders Behavior Chemically-Induced Disorders Mental Disorders Mental Health Personal Satisfaction Psychological Well-Being

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SET-R/Healthy Home

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Acronym: SET-R

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2016
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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