NCT02702193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 20, 2018

Completed
Last Updated

December 20, 2018

Status Verified

November 1, 2018

Enrollment Period

4.1 years

First QC Date

March 2, 2016

Results QC Date

October 2, 2018

Last Update Submit

November 30, 2018

Conditions

Substance-Related DisordersMental Health

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (8)

  • Trajectory of Sleep Disturbance of Participants

    baseline, 4, 8 and 12 months

  • Trajectory of Fatigue of Participants

    baseline, 4, 8 and 12 months

  • Trajectory of Pain Experienced by Participants

    baseline, 4, 8 and 12 months

  • Trajectory of Physical Function of Participants

    baseline, 4, 8 and 12 months

  • Trajectory of Oral Health Problems of Participants

    baseline, 4, 8 and 12 months

  • +3 more secondary outcomes

Study Arms (2)

SET-R/Healthy Home

EXPERIMENTAL

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

TAU

NO INTERVENTION

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.

Interventions

SET-R/Healthy HomeBEHAVIORAL

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.

SET-R/Healthy Home

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

Related Publications (4)

  • 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.

    PMID: 21171773BACKGROUND

  • 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.

    PMID: 20594207BACKGROUND

  • 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.

    PMID: 20538417BACKGROUND

  • 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.

    PMID: 32102585DERIVED

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonal SatisfactionBehavior

Results Point of Contact

Title
Victoria Mitrani
Organization
University of Miami
vmitrani@miami.edu
305 284-9139

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 8, 2016

Study Start

July 1, 2013

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

December 20, 2018

Results First Posted

December 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)