Mental Health, Substance-Related Disorders
Conditions
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.
Interventions
BEHAVIORALSET-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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trajectory of Depression of Participants | 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. |
| Trajectory of Anxiety of Participants | 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
| Measure | Time frame | Description |
|---|---|---|
| Trajectory of Pain Experienced by Participants | 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. |
| Trajectory of Physical Function of Participants | 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. |
| Trajectory of Oral Health Problems of Participants | 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. |
| Trajectory of Sleep Disturbance of Participants | 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. |
| Trajectory of Alcohol Intoxication of Participants | baseline, 4, 8 and 12 months | Self-reported Alcohol Intoxication as measured by the Addiction Severity Index. |
| Trajectory of Illicit Drug Use of Participants | baseline, 4, 8 and 12 months | Self-reported Illicit Drug Use as measured by the Addiction Severity Index. |
| Trajectory of Daily Smoking of Participants | baseline, 4, 8 and 12 months | Self-reported Daily Smoking as measured by the Addiction Severity Index. |
| Trajectory of Fatigue of Participants | 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. |
Countries
United States
Participant flow
Pre-assignment details
Screening: 243 were screened of which there were 70 excluded (9 did not meet inclusion criteria; 32 declined participation; 29 were lost contacts)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 85 |
| 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. | 87 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Month Follow up | Lost to Follow-up | 16 | 18 |
| 12 Month Follow up | Withdrawal by Subject | 1 | 0 |
| 4 Month Follow up | Lost to Follow-up | 17 | 18 |
| 4 Month Follow up | Withdrawal by Subject | 1 | 0 |
| 8 Month Follow up | Lost to Follow-up | 14 | 18 |
| 8 Month Follow up | Withdrawal by Subject | 1 | 0 |
| Baseline Assessment/Randomization | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | SET-R/Healthy Home | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants | 87 Participants | 172 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 13 Participants | 9 Participants | 22 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 65 Participants | 72 Participants | 137 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White Non Hispanic | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Female | 85 Participants | 87 Participants | 172 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 87 |
| other Total, other adverse events | 0 / 86 | 0 / 87 |
| serious Total, serious adverse events | 0 / 86 | 0 / 87 |
Outcome results
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.
Time frame: baseline, 4, 8 and 12 months
Population: Intent to Treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SET-R/Healthy Home | Trajectory of Anxiety of Participants | Participants Above Clinical Cutoff: Baseline | 49 Participants |
| SET-R/Healthy Home | Trajectory of Anxiety of Participants | Participants Above Clinical Cutoff: 4 month | 37 Participants |
| SET-R/Healthy Home | Trajectory of Anxiety of Participants | Participants Above Clinical Cutoff: 8 month | 32 Participants |
| SET-R/Healthy Home | Trajectory of Anxiety of Participants | Participants Above Clinical Cutoff: 12 month | 26 Participants |
| Treatment As Usual (TAU) | Trajectory of Anxiety of Participants | Participants Above Clinical Cutoff: 12 month | 32 Participants |
| Treatment As Usual (TAU) | Trajectory of Anxiety of Participants | Participants Above Clinical Cutoff: Baseline | 48 Participants |
| Treatment As Usual (TAU) | Trajectory of Anxiety of Participants | Participants Above Clinical Cutoff: 8 month | 31 Participants |
| Treatment As Usual (TAU) | Trajectory of Anxiety of Participants | Participants Above Clinical Cutoff: 4 month | 36 Participants |
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.
Time frame: baseline, 4, 8 and 12 months
Population: Intent to Treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SET-R/Healthy Home | Trajectory of Depression of Participants | Participants Above Clinical Cutoff: Baseline | 40 Participants |
| SET-R/Healthy Home | Trajectory of Depression of Participants | Participants Above Clinical Cutoff: 4 month | 18 Participants |
| SET-R/Healthy Home | Trajectory of Depression of Participants | Participants Above Clinical Cutoff: 8 month | 25 Participants |
| SET-R/Healthy Home | Trajectory of Depression of Participants | Participants Above Clinical Cutoff: 12 month | 21 Participants |
| Treatment As Usual (TAU) | Trajectory of Depression of Participants | Participants Above Clinical Cutoff: 12 month | 23 Participants |
| Treatment As Usual (TAU) | Trajectory of Depression of Participants | Participants Above Clinical Cutoff: Baseline | 28 Participants |
| Treatment As Usual (TAU) | Trajectory of Depression of Participants | Participants Above Clinical Cutoff: 8 month | 23 Participants |
| Treatment As Usual (TAU) | Trajectory of Depression of Participants | Participants Above Clinical Cutoff: 4 month | 27 Participants |
Comparison: To determine sample size for the grant proposal we conducted simulation studies in Mplus (Muthén \& Muthén, 2010) following the procedure described by Muthén and Muthén (2002). Each simulation created 10,000 datasets, assuming a medium-size (d = .5) intervention effect, and attrition of 10% at each assessment. For α= .05, the power estimate was at or above 80% with a sample of 172 mothers.p-value: <0.05Generalized Estimating Equations (GEE)
Secondary
Trajectory of Alcohol Intoxication of Participants
Self-reported Alcohol Intoxication as measured by the Addiction Severity Index.
Time frame: baseline, 4, 8 and 12 months
Population: Intent to Treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SET-R/Healthy Home | Trajectory of Alcohol Intoxication of Participants | Number intoxicated in last 30 days: Baseline | 4 Participants |
| SET-R/Healthy Home | Trajectory of Alcohol Intoxication of Participants | Number intoxicated in last 30 days: 4 month | 4 Participants |
| SET-R/Healthy Home | Trajectory of Alcohol Intoxication of Participants | Number intoxicated in last 30 days: 8 month | 7 Participants |
| SET-R/Healthy Home | Trajectory of Alcohol Intoxication of Participants | Number intoxicated in last 30 days: 12 month | 4 Participants |
| Treatment As Usual (TAU) | Trajectory of Alcohol Intoxication of Participants | Number intoxicated in last 30 days: 12 month | 7 Participants |
| Treatment As Usual (TAU) | Trajectory of Alcohol Intoxication of Participants | Number intoxicated in last 30 days: Baseline | 3 Participants |
| Treatment As Usual (TAU) | Trajectory of Alcohol Intoxication of Participants | Number intoxicated in last 30 days: 8 month | 4 Participants |
| Treatment As Usual (TAU) | Trajectory of Alcohol Intoxication of Participants | Number intoxicated in last 30 days: 4 month | 4 Participants |
Secondary
Trajectory of Daily Smoking of Participants
Self-reported Daily Smoking as measured by the Addiction Severity Index.
Time frame: baseline, 4, 8 and 12 months
Population: Intent to Treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SET-R/Healthy Home | Trajectory of Daily Smoking of Participants | Participants who smoked in last 30 days: Baseline | 21 Participants |
| SET-R/Healthy Home | Trajectory of Daily Smoking of Participants | Participants who smoked in last 30 days: 4 month | 16 Participants |
| SET-R/Healthy Home | Trajectory of Daily Smoking of Participants | Participants who smoked in last 30 days: 8 month | 16 Participants |
| SET-R/Healthy Home | Trajectory of Daily Smoking of Participants | Participants who smoked in last 30 days: 12 month | 14 Participants |
| Treatment As Usual (TAU) | Trajectory of Daily Smoking of Participants | Participants who smoked in last 30 days: 12 month | 18 Participants |
| Treatment As Usual (TAU) | Trajectory of Daily Smoking of Participants | Participants who smoked in last 30 days: Baseline | 21 Participants |
| Treatment As Usual (TAU) | Trajectory of Daily Smoking of Participants | Participants who smoked in last 30 days: 8 month | 16 Participants |
| Treatment As Usual (TAU) | Trajectory of Daily Smoking of Participants | Participants who smoked in last 30 days: 4 month | 17 Participants |
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.
Time frame: baseline, 4, 8 and 12 months
Population: Intent to Treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SET-R/Healthy Home | Trajectory of Fatigue of Participants | Participants Above Clinical Cutoff: Baseline | 25 Participants |
| SET-R/Healthy Home | Trajectory of Fatigue of Participants | Participants Above Clinical Cutoff: 4 month | 20 Participants |
| SET-R/Healthy Home | Trajectory of Fatigue of Participants | Participants Above Clinical Cutoff: 8 month | 24 Participants |
| SET-R/Healthy Home | Trajectory of Fatigue of Participants | Participants Above Clinical Cutoff: 12 month | 16 Participants |
| Treatment As Usual (TAU) | Trajectory of Fatigue of Participants | Participants Above Clinical Cutoff: 12 month | 20 Participants |
| Treatment As Usual (TAU) | Trajectory of Fatigue of Participants | Participants Above Clinical Cutoff: Baseline | 27 Participants |
| Treatment As Usual (TAU) | Trajectory of Fatigue of Participants | Participants Above Clinical Cutoff: 8 month | 18 Participants |
| Treatment As Usual (TAU) | Trajectory of Fatigue of Participants | Participants Above Clinical Cutoff: 4 month | 24 Participants |
Secondary
Trajectory of Illicit Drug Use of Participants
Self-reported Illicit Drug Use as measured by the Addiction Severity Index.
Time frame: baseline, 4, 8 and 12 months
Population: Intent to Treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SET-R/Healthy Home | Trajectory of Illicit Drug Use of Participants | Number who used drugs in last 30 days: Baseline | 12 Participants |
| SET-R/Healthy Home | Trajectory of Illicit Drug Use of Participants | Number who used drugs in last 30 days: 4 month | 7 Participants |
| SET-R/Healthy Home | Trajectory of Illicit Drug Use of Participants | Number who used drugs in last 30 days: 8 month | 7 Participants |
| SET-R/Healthy Home | Trajectory of Illicit Drug Use of Participants | Number who used drugs in last 30 days: 12 month | 9 Participants |
| Treatment As Usual (TAU) | Trajectory of Illicit Drug Use of Participants | Number who used drugs in last 30 days: 12 month | 4 Participants |
| Treatment As Usual (TAU) | Trajectory of Illicit Drug Use of Participants | Number who used drugs in last 30 days: Baseline | 8 Participants |
| Treatment As Usual (TAU) | Trajectory of Illicit Drug Use of Participants | Number who used drugs in last 30 days: 8 month | 3 Participants |
| Treatment As Usual (TAU) | Trajectory of Illicit Drug Use of Participants | Number who used drugs in last 30 days: 4 month | 5 Participants |
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.
Time frame: baseline, 4, 8 and 12 months
Population: Intent to Treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SET-R/Healthy Home | Trajectory of Oral Health Problems of Participants | Participants with More than 2 Problems: Baseline | 44 Participants |
| SET-R/Healthy Home | Trajectory of Oral Health Problems of Participants | Participants with More than 2 Problems: 4 month | 33 Participants |
| SET-R/Healthy Home | Trajectory of Oral Health Problems of Participants | Participants with More than 2 Problems: 8 month | 30 Participants |
| SET-R/Healthy Home | Trajectory of Oral Health Problems of Participants | Participants with More than 2 Problems: 12 month | 26 Participants |
| Treatment As Usual (TAU) | Trajectory of Oral Health Problems of Participants | Participants with More than 2 Problems: 12 month | 19 Participants |
| Treatment As Usual (TAU) | Trajectory of Oral Health Problems of Participants | Participants with More than 2 Problems: Baseline | 45 Participants |
| Treatment As Usual (TAU) | Trajectory of Oral Health Problems of Participants | Participants with More than 2 Problems: 8 month | 28 Participants |
| Treatment As Usual (TAU) | Trajectory of Oral Health Problems of Participants | Participants with More than 2 Problems: 4 month | 33 Participants |
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.
Time frame: baseline, 4, 8 and 12 months
Population: Intent to Treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SET-R/Healthy Home | Trajectory of Pain Experienced by Participants | Participants Above Clinical Cutoff: Baseline | 24 Participants |
| SET-R/Healthy Home | Trajectory of Pain Experienced by Participants | Participants Above Clinical Cutoff: 4 month | 18 Participants |
| SET-R/Healthy Home | Trajectory of Pain Experienced by Participants | Participants Above Clinical Cutoff: 8 month | 19 Participants |
| SET-R/Healthy Home | Trajectory of Pain Experienced by Participants | Participants Above Clinical Cutoff: 12 month | 17 Participants |
| Treatment As Usual (TAU) | Trajectory of Pain Experienced by Participants | Participants Above Clinical Cutoff: 12 month | 24 Participants |
| Treatment As Usual (TAU) | Trajectory of Pain Experienced by Participants | Participants Above Clinical Cutoff: Baseline | 30 Participants |
| Treatment As Usual (TAU) | Trajectory of Pain Experienced by Participants | Participants Above Clinical Cutoff: 8 month | 21 Participants |
| Treatment As Usual (TAU) | Trajectory of Pain Experienced by Participants | Participants Above Clinical Cutoff: 4 month | 26 Participants |
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.
Time frame: baseline, 4, 8 and 12 months
Population: Intent to Treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SET-R/Healthy Home | Trajectory of Physical Function of Participants | Participants Better than Clinical Cutoff: Baseline | 65 Participants |
| SET-R/Healthy Home | Trajectory of Physical Function of Participants | Participants Better than Clinical Cutoff: 4 month | 51 Participants |
| SET-R/Healthy Home | Trajectory of Physical Function of Participants | Participants Better than Clinical Cutoff: 8 month | 50 Participants |
| SET-R/Healthy Home | Trajectory of Physical Function of Participants | Participants Better than Clinical Cutoff: 12 month | 58 Participants |
| Treatment As Usual (TAU) | Trajectory of Physical Function of Participants | Participants Better than Clinical Cutoff: 12 month | 49 Participants |
| Treatment As Usual (TAU) | Trajectory of Physical Function of Participants | Participants Better than Clinical Cutoff: Baseline | 65 Participants |
| Treatment As Usual (TAU) | Trajectory of Physical Function of Participants | Participants Better than Clinical Cutoff: 8 month | 53 Participants |
| Treatment As Usual (TAU) | Trajectory of Physical Function of Participants | Participants Better than Clinical Cutoff: 4 month | 48 Participants |
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.
Time frame: baseline, 4, 8 and 12 months
Population: Intent to Treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SET-R/Healthy Home | Trajectory of Sleep Disturbance of Participants | Participants Above Clinical Cutoff: Baseline | 30 Participants |
| SET-R/Healthy Home | Trajectory of Sleep Disturbance of Participants | Participants Above Clinical Cutoff: 4 month | 24 Participants |
| SET-R/Healthy Home | Trajectory of Sleep Disturbance of Participants | Participants Above Clinical Cutoff: 8 month | 16 Participants |
| SET-R/Healthy Home | Trajectory of Sleep Disturbance of Participants | Participants Above Clinical Cutoff: 12 month | 13 Participants |
| Treatment As Usual (TAU) | Trajectory of Sleep Disturbance of Participants | Participants Above Clinical Cutoff: 12 month | 19 Participants |
| Treatment As Usual (TAU) | Trajectory of Sleep Disturbance of Participants | Participants Above Clinical Cutoff: Baseline | 28 Participants |
| Treatment As Usual (TAU) | Trajectory of Sleep Disturbance of Participants | Participants Above Clinical Cutoff: 8 month | 25 Participants |
| Treatment As Usual (TAU) | Trajectory of Sleep Disturbance of Participants | Participants Above Clinical Cutoff: 4 month | 17 Participants |