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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD002266 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Trajectory of Fatigue of Participants |
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Inclusion Criteria:
Exclusion Criteria:
Persons who do not meet the inclusion criteria listed above will be excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21171773 | Background | 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. | |
| 20594207 | Background | 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. |
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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.
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Screening: 243 were screened of which there were 70 excluded (9 did not meet inclusion criteria; 32 declined participation; 29 were lost contacts)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Treatment As Usual (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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessment/Randomization |
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| 4 Month Follow up |
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| 8 Month Follow up |
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| 12 Month Follow up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to Treat analysis | Posted | Count of Participants | Participants | baseline, 4, 8 and 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Mitrani | University of Miami | 305 284-9139 | vmitrani@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2016 | Oct 2, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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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 |
| 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 |
| 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 |
| 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 |
| Trajectory of Daily Smoking of Participants | Self-reported Daily Smoking as measured by the Addiction Severity Index. | baseline, 4, 8 and 12 months |
| Trajectory of Alcohol Intoxication of Participants | Self-reported Alcohol Intoxication as measured by the Addiction Severity Index. | baseline, 4, 8 and 12 months |
| 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 |
| 20538417 | Background | 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. |
| 32102585 | Derived | 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. |
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| BG001 | Treatment as Usual (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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Treatment As Usual (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. |
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| 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. | Intent to Treat analysis | Posted | Count of Participants | Participants | baseline, 4, 8 and 12 months |
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| 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. | Intent to Treat analysis | Posted | Count of Participants | Participants | baseline, 4, 8 and 12 months |
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| 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. | Intent to Treat analysis | Posted | Count of Participants | Participants | baseline, 4, 8 and 12 months |
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| 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. | Intent to Treat analysis | Posted | Count of Participants | Participants | baseline, 4, 8 and 12 months |
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| 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. | Intent to Treat analysis | Posted | Count of Participants | Participants | baseline, 4, 8 and 12 months |
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| 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. | Intent to Treat analysis | Posted | Count of Participants | Participants | baseline, 4, 8 and 12 months |
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| Secondary | Trajectory of Daily Smoking of Participants | Self-reported Daily Smoking as measured by the Addiction Severity Index. | Intent to Treat analysis | Posted | Count of Participants | Participants | baseline, 4, 8 and 12 months |
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| Secondary | Trajectory of Alcohol Intoxication of Participants | Self-reported Alcohol Intoxication as measured by the Addiction Severity Index. | Intent to Treat analysis | Posted | Count of Participants | Participants | baseline, 4, 8 and 12 months |
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| Secondary | Trajectory of Illicit Drug Use of Participants | Self-reported Illicit Drug Use as measured by the Addiction Severity Index. | Intent to Treat analysis | Posted | Count of Participants | Participants | baseline, 4, 8 and 12 months |
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| 0 |
| 86 |
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | Treatment As Usual (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. | 0 | 87 | 0 | 87 | 0 | 87 |
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| Participants Above Clinical Cutoff: 8 month |
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| Participants Above Clinical Cutoff: 12 month |
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| Participants Above Clinical Cutoff: 8 month |
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| Participants Above Clinical Cutoff: 12 month |
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| Participants Above Clinical Cutoff: 8 month |
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| Participants Above Clinical Cutoff: 12 month |
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| Participants Above Clinical Cutoff: 8 month |
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| Participants Above Clinical Cutoff: 12 month |
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| Participants Better than Clinical Cutoff: 8 month |
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| Participants Better than Clinical Cutoff: 12 month |
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| Participants with More than 2 Problems: 8 month |
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| Participants with More than 2 Problems: 12 month |
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| Participants who smoked in last 30 days: 8 month |
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| Participants who smoked in last 30 days: 12 month |
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| Number intoxicated in last 30 days: 8 month |
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| Number intoxicated in last 30 days: 12 month |
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| Number who used drugs in last 30 days: 8 month |
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| Number who used drugs in last 30 days: 12 month |
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