Set-Enhanced Aftercare for Mothers in Substance Abuse Recovery and Their Children
Phase: NA
Conditions: Substance-Related Disorders, Mental Health
Sponsor: University of Miami

 
 
 
University of Miami - Miller School of Medicine 
Set-Enhanced Aftercare for Mothers 
in Substance Abuse Recovery and 
Their Children 
Version Date 6-7-2016 
National Clinical Trial Number: NCT02702193 
Victoria Mitrani 
 
 

 
4. Description of Study 
Study Protocol 
4.1. * Abstract and Specific Aims  
Include a brief summary of the significance, purpose or research question, specific 
aims, and risks/benefits. Specific aims include hypotheses you will investigate. 
The study will conduct a translational 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 non-Hispanic mothers enrolled in outpatient substance abuse, mental 
health or substance abuse as a co-occurring condition treatment. The study will be conducted 
with a community partner, Banyan Health Systems (also known as Miami Behavioral Health and 
Spectrum Programs), that delivers integrated substance abuse/mental health treatment and 
primary care. Agency staff will conduct data collection and agency nurses will deliver Healthy 
Home. Data will be collected at baseline and 4, 8, and 12 months post-randomization.  
 
The Specific Aims of the proposed study are to:  
1) test the effectiveness of SET for improving physical and mental health and reducing relapse 
of mothers in substance abuse/mental health recovery;  
2) test the effectiveness of SET for improving health and mental health outcomes of children of 
mothers in recovery;  
3) test mechanisms of action of SET (self care, environmental risk, family functioning and 
stigma);  
4) assess SET implementation and sustainability factors and the relationship between fidelity 
and outcomes; and  
5) examine the interactions of ethnicity and ethnicity-related factors on outcomes.  
 
SET is a manualized, strength-based, directive and process-oriented family-ecosystemic 
intervention developed to address the needs of minority women. SET targets the woman’s 
social environment by building on existing adaptive interactions and reducing maladaptive 
interactions within the family and between the woman, family and supportive resources. A 
recently completed randomized trial with minority women in drug recovery who were also HIV+ 
found that for women who were raising children, SET resulted in reduced relapse and 
psychological distress in the mothers, and reduced symptoms of depression, anxiety and 
behavioral problems in the children.  
 
The proposed study will aim to demonstrate SET's effectiveness, acceptability and feasibility for 
implementation in a community setting. The partnership between El Centro and Banyan Health 
Systems, a substance abuse, mental health and primary care provider with considerable 
research experience, provides a unique opportunity to rigorously test substance abuse/mental 
health treatment enhanced by SET in a real-world setting.  
4.2. * Research Background  
Provide background and previous studies supporting the study rationale.  Include a 
brief summary of existing knowledge relevant to the research.  Explain how the 
research may contribute to the advancement of knowledge.  
Substance abuse is a chronic condition, with high rates of relapse following treatment (Hser, 
Longshore, & Anglin, 2007; Moos, Moos, & Timko, 2006; Scott, Dennis, & Foss, 2005). The 
proportion of women in substance abuse treatment has increased over the last few decades. In 
2002, according to the Treatment Episode Data Set (TEDS), about 30% (565,000) of 
admissions to substance abuse treatment facilities were females, up from 28% in 1992 (Brady 
et al., 2005). Women with substance abuse disorders are more likely than men to experience 
mood, anxiety, and eating disorders, as well as post-traumatic stress disorder (Greenfield et al., 
2007). Women develop medical and social consequences of addiction faster than men, and are 

more susceptible to relapse (Addiction in women, 2010). Major factors contributing to women’s 
relapse include low self-worth, interpersonal conflicts which interfere with treatment, an 
inability to sever ties with her using network and environment, and a lack of knowledge and 
relapse prevention coping skills (Sun, 2007).  
 
Women with substance use disorders are more likely than women without substance use 
disorders to suffer physical and mental health conditions such as hypertension (Kataoka et al., 
2001; McCabe et al., 2002; Wechsberg, Craddock, & Hubbard, 1998), sexually transmitted 
infections (Binswanger et al., 2010), mood disorders (Kataoka et al., 2001), diabetes and other 
chronic medical disorders (Binswanger et al., 2010). They also experience higher morbidity 
from these conditions than their non-substance abusing counterparts (Wu et al., 2009) due to 
the effects of substance abuse (Albright & Rayburn, 2009; Greenfield et al., 2007) and 
suboptimal utilization of health care (Owens, 2008). Further, the stigma associated with 
substance abuse can lead to limited help-seeking behaviors and isolation, reducing access to 
support systems, a critical component for women in substance abuse recovery (Walker, 2002). 
The prevalence of health conditions upon entering or while in care among women at the 
substance abuse treatment agency in this proposal highlights the health vulnerability of this 
group: 68% with a mental health diagnosis, 50% with a sexually transmitted infection, 50% 
with dental problems, 15% with high cholesterol, 10% with hypertension, and 10% with 
diabetes.  
 
Indicators of family functioning that predict substance abuse relapse include emotional distance, 
lack of open communication (Lavee & Altus, 2001), and lack of support from male partners 
(Laudet, Magura, Furst et al., 1999). Outcome studies have demonstrated that family support is 
associated with fewer depressive symptoms and lower alcohol consumption two years after 
treatment (Finney, Moos, & Newborn, 1980). As compared to men in recovery, women have 
greater involvement with family, and thus have the potential for more problematic relationships 
with family members and substance using partners that challenge sobriety (Boyd, Blow, & 
Orgain, 1993; Grella et al., 2003; Knight, Logan, & Simpson, 2001; Westermeyer & Boedicker, 
2000), as well as greater potential for involvement in supportive family relationships that foster 
sobriety (Hunt & Seeman, 1990). Further, because psychosocial factors such as family stress, 
problematic romantic relationships, and psychological distress have been linked to substance 
abuse and dependence (Aneshensel, 1999), reducing these stressors may prevent relapse.  
 
Substance abuse affects the entire family and is associated with disruptions in parenting 
(Boland, Czarniecki & Haiken,1992; Smith, 1996; Williams & O'Connor,1995) and violence in 
couples (e.g., Gondolf & Foster,1991; O'Farrell & Murphy,1995). The substance abuse of a 
mother can increase a range of risks to her children from environmental (such as unsafe living 
conditions), psychological, and physical causes (Johnson & Leff, 1999). Children of substance 
users are at high risk for developing substance use disorders, lives characterized by high parent 
and family conflict, frequent moves, household financial troubles, and family legal conflicts 
(Haggerty et al., 2008). When mothers experience mental health issues, substance use, or 
domestic violence, their children have greater risk of mental health issues, substance use, or 
domestic violence (Whitaker, Orzol, & Kahn, 2006). Despite these challenges, mothers with 
substance abuse disorders can be particularly motivated to receive and remain in substance 
abuse treatment as a means of regaining child custody and being better mothers (McComish et 
al. 2003; Scott-Lennox et al. 2000).  
 
Given these reciprocal and intertwined effects between family functioning and substance abuse, 
mobilizing family protective factors and reducing family risk factors can be a promising 
approach for preventing relapse, and by extension, improving health for mothers in recovery 
and buffering children against the negative effects of maternal substance abuse.  
 
Preliminary Data. 
SET has been tested in three randomized trials funded by the NIH that focused either 
exclusively or predominantly on persons from minority groups (Hispanic or African American) 
with substance use disorders.  
 

SET for substance-abusing African American and Hispanic adolescents (R01DA10574, José 
Szapocznik, PI). SET was originally developed for adolescents with substance abuse disorders 
and involved with the juvenile justice system. A randomized trial compared SET with family 
therapy as usual and community services control with 190 African American and Hispanic 
adolescents with substance use disorders. Follow-up assessments were conducted at 3, 6, 12, 
and 18 months post-randomization. SET was more efficacious than the other two conditions in 
reducing drug use among Hispanic adolescents, B = 3.34, t(160) = 2.15, p < .05, and in 
improving family interactions (conflict, cohesion, and parenting ) in both ethnic groups (Robbins 
et al., 2008). 
 
SET for HIV seropositive African American mothers (MH55796, José Szapocznik, PI). SET was 
adapted and tested in comparison to an individual person-centered intervention and to a 
community control group with 209 African American HIV seropositive mothers. Follow-up 
assessments were conducted at 3, 6, 9, and 18 months post-randomization. SET was superior 
to both of the other conditions in reducing family hassles, F(6, 472) = 2.53, p <.05, and 
psychological distress, F(6, 472) = 2.19, p <.05, (Szapocznik et al., 2004). Moreover, SET was 
superior to the person-centered intervention in reducing drug relapse, χ²(1) = 5.35, p <.05, 
among the 68% of the sample with drug use history. Relapse prevention was mediated by 
reductions in family hassles. t(120) = 2.59, p <.01 (Feaster, Burns, et al., 2010).  
 
SET for HIV seropositive women in drug abuse recovery (R01DA15004, Daniel Feaster, PI; 
R01DA16543, Victoria Mitrani, PI). In response to the findings described above regarding the 
potential of SET for reducing drug relapse, the SET model was adapted to focus specifically on 
women in recovery. SET was compared with a supportive psychoeducational health group in a 
randomized trial with 126 predominantly African American HIV seropositive women in recovery. 
Follow-up assessments were conducted at 4, 8, and 12 months post-randomization. Women in 
SET showed improvement in CD4T-cell count, B = 77.02, SE = 30.18, p < .05, and in 
theoretical mechanisms of action on drug relapse including accessing substance abuse services 
in response to relapse, B = -.74, SE = .25, p < .01, and separating from drug-using household 
members, B = -.35, SE = .12, p < .01 (Feaster, Mitrani, et al, 2010). A companion study 
enrolled the women’s family members to examine the family mechanisms SET; SET prevented 
the deterioration of family functioning, B = -0.05, SE = 0.02, p < .01, that was evident in the 
families of women in the health group and of those who did not participate in their respective 
interventions (Mitrani et al., under review). In a subgroup analysis of women (n=25) raising 
children (n=42) SET was more efficacious than the control in decreasing children’s internalizing, 
B = -1.94, SE = 0.73, p < .01, and externalizing, B = -2.17, SE = 0.58, p < .001, behaviors, 
reducing mothers’ psychological distress, B = -0.25, SE = 0.09, p < .01, and preventing 
mothers’ relapse, B = -.29, SE = 0.15, p < .05. Children in SET reported improvements in 
parenting, B = 0.15, SE = 0.07, p < .05, compared to the children of mothers in the control 
(Mitrani, McCabe et al., 2010). Women raising children were more likely to engage in SET and 
the control condition B = 1.25, SE = 0.58, p < .05, (Mitrani, Feaster, Weiss-Laxer and McCabe, 
2010) indicating that mothers in recovery are particularly motivated to participate in 
psychosocial interventions.  
 
Mother’s in recovery qualitative study. Thirteen mothers currently or recently discharged from 
substance abuse treatment at Banyan were interviewed regarding family influence on 
treatment, recovery and relapse, and attitudes/preferences regarding family aftercare. 
Preliminary review (formal content analysis is ongoing) suggests the following themes: 1) 
Children and family are the major motivation to remain substance-free; 2) Partner 
relationships, stress, family problems, shame/guilt, depression and environmental cues are the 
most challenging for abstinence; 3) Mothers want to involve supportive family members 
(especially children) in a home-based family aftercare intervention to address family healing, 
improve communication and support, establish family boundaries, re-establish maternal roles 
and repair parent-child relationships.  
 
 

4.3. If you have cited references above, please attach a bibliography, including 
title, full author list, journal, date and pages.  This bibliography should 
include only those articles referenced above. 
 
Name 
Description 
Version 
SET R Refs for IRB.docx 
  
0.01 
 
  
4a. Description of Study (cont'd) 
Rationale and Methodology 
4.4. * In non-technical, lay language, describe the study design and all study procedures, 
in order of sequence and timing.  Include length of subject participation, what tasks 
are involved in the study, what tests or procedures subjects will be asked to complete 
or undergo, specific measures to be used, etc.  If applicable, include frequency of 
visits, duration of visits, and study procedure calendar.  
Study design: The study uses a mixed design in which mothers who are enrolled in outpatient 
substance abuse/mental health treatment (or treatment for substance abuse as a co-occurring 
condition) will be randomized to outpatient substance abuse/mental health (or co-occurring) 
treatment enhanced by Healthy Home (TAU + Healthy Home) or outpatient substance 
abuse/mental health (or co-occurring) treatment as usual (TAU). Mothers and their minor 
children enrolled in the study (ages 2-17) will be assessed 4 times at 4 month intervals: 
Baseline, 4 months, 8 months, and 12 months (with a window for final assessment up to 18 
months). Randomization will take place after the baseline assessment.  
 
Study Setting: Participant recruitment, outreach, consent and data collection, as well as the 
interventions, will be conducted by staff of the Banyan Health Systems (Banyan), a joint 
venture between Spectrum Programs, Inc. and Miami Behavioral Health Center, Inc. which 
joined forces 6 years ago to integrate mental health and substance abuse treatment services.  
 
Screening, Recruitment and Retention: Study staff employed by Banyan will invite all women 
who are enrolled in outpatient substance abuse, mental health (or co-occurring) treatment or 
case management at Banyan and who have minor children to participate in the study. Study 
staff will also accept referrals from women receiving outpatient substance abuse, mental health 
(or co-occurring) treatment at other centers. Study staff will ask local agencies that serve 
women who receive mental health or substance abuse treatment to provide contact information 
for their clients who have consented to be called regarding the study. Those women will be 
called by study staff for recruitment to the study. The study will also be promoted via social 
media (e.g., Craigslist); potential participants will be instructed to call the study number - there 
will be no direct communication with individual study candidates via social media.  For purposes 
of participant recruitment and retention, communication with participants includes email and 
text messages. The body of the messages will not include any mentions of private health 
information. Participants also receive greeting cards (e.g., mother's day, birthday, holiday) from 
the study team. 

After the baseline assessment, the mother will be given a postcard indicating her treatment 
conditions (uploaded in section 6.2a). Staff will call enrolled women monthly to check in 
regarding plans to relocate, changes in contact information and to remind them of their next 
assessment appointment. Mothers who are unavailable for in-person assessments (e.g., if they 
have relocated out of town) may have their assessments by phone.  
 
Pilot Phase: There will be a period used for piloting, refining and manualizing procedures, 
training the study team, translation of materials to Spanish as needed, and to apply for a 
Certificate of Confidentiality. The research procedures including recruiting, screening, 
consenting/assenting and data collection will be pilot tested with up to four sets of mothers and 
children at up to two time-points. [This portion of the study has been completed]. 
 
Measures:  
A table listing each construct, instrument and translation information is attached. Most of the 
measures have Spanish versions – either published or used in previous protocols, if not they 
will be translated using translation/back-translation methods. The following measures are 
planned to be used with mothers and children. No additional instruments or measures will be 
used without seeking IRB approval.  
 
Mother Outcome Measures 
-Mental Health will be assessed using the Hospital Anxiety and Depression Scale (Zigmond & 
Snaith, 1983) .  
-Physical Health will be assessed using the PROMIS Global Health Scale (Hays, Bjorner, Revicki, 
Spritzer, & Cella, 2009). Clinical measurement of height and weight (i.e., body mass index) and 
waist circumference will be indicators of obesity.  
-Dental Health will be assessed using the Oral Health Impact Profile short form (OHIP-14) 
(Slade, 1997).  
-Substance Use will be assessed using the Addiction Severity Index Lite Alcohol and Drug Scale 
(McGahan, Griffith, Parente, McLellan, 1986), and a urine drug toxicology test.  
 
Child Outcome Measures 
-Mental health will be assessed using the Youth Self-Report (Achenbach & Rescorla, 2001) and 
Child Behavior Checklist (CBCL; Achenbach, 2009).  
-Physical Health will be assessed with the Child Health Questionnaire (Landgraf & Abtez, 1997). 
Additionally, height and weight will be obtained to calculate BMI. No urine or blood samples will 
be taken from children.  
-Dental Health will be assessed using the Oral Health Impact Profile-14 (Slade, 1997) and three 
items from the Florida Dental Health Survey (Gilbert & Litaker, 2007).  
Child medical condition Measure. This measure combines items from the Caregiver Strain 
Questionnaire (Brannan, Heflinger, & Brickman, 1997) and modified items from the Early 
Childhood Longitudinal Survey-Birth Cohort questionnaires. The measure with Spanish and 
English items is attached in Supporting documents.  For this study, 1 item will assess whether a 
child has any medical condition, and what condition, if one exists.  9 items will assess the strain 
associated with the condition on a 5-point Likert scale. 2 items will assess whether the child 
receives services for the condition (e.g., speech therapy), and where services are received 
(e.g., school, home). 1 item asks for the number of hours received on average per week. The 
Caregiver Strain measure was used, in Spanish and English, in a previous IRB-Approved study 
(20070334) and the other items were translated from English into Spanish using a translation-
back translation process for this study (statements attached in supporting documents).  
The measure will be administered at baseline. If enrolled mothers have already completed the 
baseline, they will complete the form at one of the follow-up assessments. If participants have 
already completed all of the assessments, then study staff will attempt to contact the 
participant to complete the measure by phone. 

We are requesting a Waiver of Signed Consent for this measure for the only participants who 
have already completed their baseline and all other assessments. They will answer these 
questions by phone to complete this measure. The Waiver is requested to avoid burdening 
participants who have already signed consent forms for this study, and would have to schedule 
an additional meeting to complete the consent form for this measure. 
Mediator variables. 
-Mother Self-care: Health Care Use will be assessed using the Stanford Health Care Utilization 
(Lorig, Stewart, Ritter, Gonzalez, Laurent, & Lynch, 1996) plus items from El Centro 
Demographics Scale and using two questions about recency of physical check-up and Pap test. 
Dental Care Use will be assessed using the Florida Dental Health Survey (Gilbert & Litaker, 
2007). Form 90 Treatment/Living Experiences subscale (Tonigan, Miller, & Brown, 1997) and 
substance abuse treatment attendance records from Banyan will assess use of substance abuse 
services and self-help groups. 
-Family Functioning will be measured with the family cohesion subscale of the Family 
Environment Scale (Moos & Moos, 1981). Family Coping will be measured with two subscales 
from the Family-Crisis Oriented Evaluation Scales (F-COPES; McCubbin, Larsen, & Olsen, 
1996).  
-Social Support will be assessed using the Important People Interview (Clifford & Langabuagh, 
1991) .  
-Stigma will be measured using a version of a Stigma scale (Ahern, Stuber, & Galea, 2007). 
-Maternal Parenting Functioning will be assessed using the Parenting Practices Questionnaire 
(Gorman-Smith, Tolan, Zelli, & Huesmann, 1996) and Parenting Self Agency (Dumka, 
Stoerzinger, Jackson & Roosa; 1996) . 
 
Moderator Measures 
-Ethnicity (Black, Hispanic, White non-Hispanic), Socio-economic Status and general 
demographic information will be collected using demographics items from El Centro and other 
UM IRB-approved studies.  
-Household Composition and Stability will be collected using a Household Composition Form.  
-Mother’s Stress will be assessed using the Hassles Scale (DeLongis, Folkman, & Lazarus, 
1988)  
- Mother’s Abuse and History of Abuse will be measured using the Violence Scale (Peragallo, 
2005).  
-Mother’s Sleep will be assessed with 4 items regarding sleep from the PROMIS-29 Health 
Scale.  
We will be extracting some information from our intervention clinical forms to capture some of 
our research constructs. This information includes data related to health assessments, 
recommendations/referrals, treatment/services rendered, follow-up plan of care, and education. 
The data collection form has been created in RedCap (Research electronic data capture), an 
electronic data capture software. A table demonstrating items extracted from the clinical forms 
is uploaded to the eprost protocol. These clinical forms are kept in the locked research vault at 
the School of Nursing and Health Studies and will be protected at all times. RedCap data will be 
kept in password protected files.      
Nurse Progress Notes. These measures take information from clinical progress notes completed 
by nurses in the Healthy Home condition. There are 2 parts of this measure. First, the nursing 
intake note will be transcribed into an electronic format. Second, clinical progress notes for 
each nurse visit will also be transcribed into an electronic format. The transcription is similar to 
a chart review process, and will be completed for each family member’s health status using 
clinical forms based on the standard documents used as clinical progress notes by Banyan. 
We are requesting a waiver of consent for this data extraction. All subjects involved sign 
consent for the parent study.  This data will be analyzed using secondary analysis. 
 
Follow-up for positive clinical indicators. Mothers or children who report suicidal thoughts or 
intention to hurt others will be interviewed by a licensed health professional on site or by 

telephone, or staff will call the Crisis Stabilization Unit or 911 as indicated. Reports of child 
abuse or neglect will be reported to the authorities as per Florida law and to corresponding SET 
or TAU clinical supervisor for follow-up.  
 
Contacts with mother/family participants will be conducted in the candidate/participants’ 
preferred language (English or Spanish). Data will typically be obtained in interviewer format as 
follows. The data collector will meet with the participant in a private room, read the questions 
and the participant will have the items and responses to read along. The assessor will enter the 
participant’s responses on a computer. Children will complete questionnaires appropriate to 
their age. Younger children will have the clinical measures only. Data will typically be collected 
at the sites where the mothers receive substance abuse treatment. Home-based assessments 
will be offered. It is estimated that data collection procedures will take 90 minutes for mothers 
(+30 minutes x number of children) and 50 minutes for children. Breaks will be offered and 
snacks may be offered.  
 
Interventions. The study intervention period is scheduled for 4 months. Healthy Home and 
substance abuse treatment services received by mothers in both conditions will be tracked to 
compare intervention exposure across conditions. Mothers in both conditions will be free to 
access any health or substance abuse services offered in their communities.  
 
- The Healthy Home intervention integrates a family therapy approach, Structural Ecosystems 
Therapy (SET), with health services for mothers in substance abuse treatment and their 
children. Healthy Home is delivered by nurses through family visits. The nurse sees the family 
all at once, so that nursing care strengthens family unity. Visits take place approximately once 
every two weeks for a period of four months in the mother’s home or other sites that are 
private and convenient to the family. Visits are ordinarily planned to include the mother, her 
children and some person(s) from the family and/or ecosystem (e.g., neighbor, friend).  
 
During family visits the nurse attends to the health of the mother, children and other family 
members who are present. The nurse assesses family members’ health needs, provides 
recommendations and education, and assists with referrals and access to services. The referrals 
for services may be to the nurse’s own facility or to other service agencies. In between visits 
the nurse interacts with other service providers – e.g., the substance abuse counselor and 
mother and children’s health care providers – to help optimize the family’s use of these services 
and to help coordinate care. The nurse incorporates SET techniques into the delivery of these 
nursing functions as a means of strengthening family functioning. The family functions we are 
particularly interested are those that support the mother’s substance abuse recovery, the 
mother’s health and the care of the children.  
 
The three basic techniques in SET are joining, structural diagnosis, and restructuring. Joining 
refers to the process of establishing therapeutic alliances. Diagnosing refers to the identification 
of interactional patterns that contribute to the problems experienced by the mother, and thus 
need to be changed, as well as those that are sources of support and thus should be reinforced. 
Restructuring involves orchestrating opportunities for individuals to interact in ways that 
reinforce strengths and change maladaptive interactional patterns. Each Healthy Home case is 
tailored to the particular needs of the mother and her family. Healthy Home consists of three 
phases of treatment: initiation, treatment, and termination. Specific focus areas include: 
Substance abuse contexts, support and family status, couple relationships, parenting, and 
health/self-care. Healthy Home training will be conducted by Dr Mitrani and another trainer. 
Healthy Home supervision will be ongoing and conducted by Dr Mitrani and Banyan clinical 
supervisors.  
 
-TAU consists of substance abuse outpatient treatment services normally offered by Banyan and 
other agencies where the women are receiving substance abuse or mental health services.  
 
In addition to collecting measures from mothers and children, staff of the Banyan Health 
System will complete measures for assessment of study implementation factors. We do not 
believe that these measures constitute human subjects research and therefore do not consider 

staff to be study participants. Measures are as follows:  
 
- Healthy Home Treatment Fidelity. Healthy Home nurses will typically complete a fidelity 
checklist after each family visit. 
- Implementation Costs will be obtained from invoices completed by agency administrators that 
cover the full range of costs involved in implementing Healthy Home, salaries (training, 
supervision, and delivery), materials, etc. Nurses will log all contacts with participants (phone 
calls, visits, time/location, purpose, etc.). Nurses will log the amount of time spent each week 
on cases that does not involve contact with participants, e.g., documentation, preparation, 
discussing cases with colleagues, training, etc.  
- Satisfaction with Implementation will be assessed using a measure adapted from a previous 
substance use intervention study (Santisteban, 2008). Nurses, supervisors and agency 
administrators will rate their satisfaction with training, supervision, interventon, and impact on 
delivery of usual services. 
 
  
4.4.A. Standard Measures: Click the "Add" button to open the search window, then click 
the "Find" button to browse and select measures. 
 
Name of Measure 
Brief Description 
Type of Measure 
There are no items to display 
 
 
NOTE: A copy of the first page of each standard measure is provided in the Library of Standard 
Measures for verification. Ensure that the version being used in this study is the same as the version 
that has been selected. 
Upload any questionnaires and/or assessment tools to be used that are not 
listed above: 
 
Name 
Description Version 
Child Behavior Checklist Preschool CBCP.040813.docx 
  
0.01 
Child Behavior Checklist Schoolage CBCS.040813.docx 
  
0.01 
CHILD DEMOGRAPHIC INTAKE FORM CDIM.docx 
  
0.03 
Child Health Questionnaire Physical and Fam Scales Child Report 
CHQC.041013.docx 
  
0.01 
Child Health Questionnaire Physical CG and Family Scales Mother 
Report CHQM. 041013.docx 
  
0.01 
Child's BMI BMIC.040913.docx 
  
0.01 
Family Environment Scale Cohesion FES.040913.docx 
  
0.01 
FCO FCOPES bilingual.docx 
  
0.01 
Fl Dental Care Study Child Rating FDSC.040813.docx 
  
0.01 
FL Dental Care Study Mother Rating Child FDSM.040813.docx 
  
0.01 
FL Dental Care Study Mother rating herself FDSW.040813.docx 
  
0.01 
Healthy Home Hassles Scale (HHH).docx 
  
0.01 
Healthy Home Important People Interview (IPI) English.docx 
  
0.01 
Healthy Home Important People Interview (IPI) Spanish.docx 
  
0.01 
HLF Health Literacy Screener HLF.041513.docx 
  
0.01 
Household Composition Form HCF.040913.docx 
  
0.01 
 

MDIF Mother Demographic-Translation v2.doc 
  
0.05 
Measures_Table_for IRB protocol.04-16-2013.docx 
  
0.01 
Modified Stigma Scale with Alcohol MSS.040913.docx 
  
0.02 
MSF (Mother Screening Form) with mental health.010914. 
  
0.01 
Oral Health Impact Scale Mother rating self OHIP.040913.docx 
  
0.01 
Pap Smear Last Check Form LCF.040913.docx 
  
0.01 
Parenting Practices Child Report PPC.041013.docx 
  
0.01 
Parenting Practices Parent Report PPP.040813.docx 
  
0.01 
Parenting Self Agency PSA.040813.docx 
  
0.01 
PER--Parent Relationship With Peer Group-Parent (English).doc 
  
0.01 
PER--Parent Relationship With Peer Group-Parent (Espanol) 
(DD).doc 
  
0.01 
PROMIS SF v1.0 - ED-Anxiety-SF8a Spanish.pdf 
  
0.01 
PROMIS SF v1.0 - ED-Anxiety-SF8a.pdf 
  
0.01 
PROMIS SF v1.0 - ED-Depression-SF8a Spanish.pdf 
  
0.01 
PROMIS SF v1.0 - ED-Depression-SF8a.pdf 
  
0.01 
SET-R Addiction Severity Index LITE (ASI).RX accomodation.docx   
0.01 
SET-R Form 90 (F90).doc 
  
0.01 
SET-R PROMIS 29 Profile ENGLISH.docx 
  
0.01 
SET-R PROMIS 29 Profile SPANISH.docx 
  
0.01 
SET-R Stanford Health care Utilization (SHU).doc 
  
0.02 
SET-R Violence (VIL).doc 
  
0.01 
Urine Drug Screen UDS.041013.docx 
  
0.01 
Youth Self Report YSR.040813.docx 
  
0.01 
4.5. Identify and distinguish between those procedures that are standard treatment 
versus those that are experimental/research-specific. 
 Not applicable 
The control condition, TAU, consists of the substance abuse/mental health outpatient treatment 
(or treatment for substance abuse as a co-occurring condition) routinely offered at the 
participants' treatment program. The Healthy Home condition consists of Healthy Home in 
addition to outpatient treatment routinely offered at the participants' treatment center. 
Therefore all participants are assigned to receive the standard of care, at minimum.The study 
intervention period is scheduled for 4 months. The outpatient program does not have a time 
limit.  
4.6. Describe any therapeutic alternatives that may exist for the study population. 
 Not applicable 
Participants who do not enroll in the study are offered the standard outpatient substance 
abuse/mental health services. 
4b. Description of Study (cont'd) 
Risk/Benefit Assessment 
4.7. * Describe the nature, degree, and if available, expected frequency of all potential 
economic/financial, legal, physical, psychological, social or other risks to which 
research participants may be exposed as a result of their participation in this 
research.  If applicable, please describe the risk of investigational agents or devices 
(side effects). 
No side effects have been noted in the current literature in association with the behavioral 

questionnaires or interviews used in this study, although as with many assessment batteries, 
some people may experience mild fatigue or momentary concern about their ability to do well. 
There is a minimal risk of distress or family strife and of family members learning about the 
mother's substance abuse/mental health problems associated with the family intervention, 
Healthy Home. We have extensive experience in delivering SET, the precursor of Healthy 
Home, and have not found it to induce lasting family stress. The control condition, TAU, 
consists of the substance abuse/mental health outpatient treatment routinely offered at the 
participants' substance abuse treatment program. Therefore all participants are assigned to 
receive the standard of care, at minimum. 
4.8. * Are there potential direct benefits of this research to the subjects? 
  
Yes 
No 
 4.8.A. If yes, provide a description of the potential direct benefits and indicate if all, 
or only some, of the subject groups may derive this potential benefit. 
The potential for benefit for all participants include: 1) They may spend some pleasant 
family time (at assessments), 2) they may gain satisfaction in knowing that they are 
helping to advance the science of family health. The additional potential benefit for 
participants randomized to the Healthy Home condition is improved health and family 
relationships that can positively impact the women and their children as well as of 
other participating family members.  
4.9. * Are there potential benefits of this research to society? 
  
Yes 
No 
 4.9.A. * Please explain: 
Women in substance abuse/mental health recovery and their children are at high risk 
for significant health consequences and there is a need for culturally-informed 
interventions tailored to address their unique needs. The proposed outpatient 
treatment enhancement approach is unique, innovative, and well suited to the needs of 
mothers in recovery. There are no existing substance abuse/mental health approaches 
that integrate family therapy with the entire family, parenting practices, and primary 
care in home-based and culturally tailored intervention. The information obtained in 
this project will aid in the development of strategies to serve women in recovery and 
their children.  
4.10. * Explain why the risk/benefit ratio supports conducting this research. 
We anticipate that this study poses a relatively low level of risk to participants. There are 
some potential benefits for participants as well as to society. 
4c. Description of Study (cont'd) 
Data 
4.11. * Describe follow-up, data storage methods, data security, authorized access to 
records and record retention, including site name and address. 
All data will be collected using Velos eResearch, paper-based questionnaires or lab reports. 
Hard-copy forms will also be used if the electronic systems are unavailable. All hard-copy data 
will be stored in locked facilities. Data will only be accessible by IRB approved protocol 
personnel or designated system administrators and only for studies and functions for which 
those individuals are specifically authorized. The database will be programmed with 
appropriate across form logic checks.  
 
QA monitoring will be conducted by staff of El Centro according to the standard procedures 
which include a QA review prior to initiation, upon conducting baseline procedures with the 

first few study participants, and then for interim reviews.  
 
4.12. * Support the study validity by describing the statistical design, including 
quantitative and qualitative methods used to analyze data. 
The following is the planed data analysis procedure as submitted in the grant application.  
 
-Testing of data quality and distributional assumptions.  
Distributions and frequencies of all measures will be examined for non-normality and 
transformed as needed. If transformation is not sufficient, other distributions (Poisson, 
Negative Binomial) or nonparametric analyses will be used. Internal consistency will be 
reported for all measures with Cronbach's alpha. If any scale alphas are below .70, item total 
correlations and/or factor analysis will be employed to diagnose the psychometric problems 
and new scales with higher internal consistency will be considered.  
 
-Evaluating the effectiveness of randomization will be accomplished by use of ANOVA and Chi-
square of baseline variables. Although not anticipated, if variables with theoretical importance 
to outcomes show baseline differences by condition, hypotheses tests will statistically control 
for (baseline) differences. 
 
-Growth curve analysis. Latent growth modeling (LGM) in Mplus 6 (Muthén & Muthén, 2010) 
will examine change over time in the outcomes. LGM involves creating latent variables 
representing growth parameters (the baseline or intercept; the linear slope or rate of change, 
the quadratic slope, etc.). It allows for the simultaneous estimation of multiple growth 
functions with growth parameters of one function related to growth parameters of another. 
Mplus allows for outcome variables with distributions that are not continuous (e.g., Poisson for 
skewed variables or logistic for binary outcomes), which is particularly important with 
substance use and health outcomes. LGM can generate effect sizes for rate of change or the 
difference at a single time between the two conditions, i.e., Cohen’s d (Cohen, 1992), 
Following Cohen's (1992) guidelines, we will interpret our effect sizes using the convention of 
"small" (d =.2), "medium" (d =.5), and "large" (d =.8). 
 
-Testing hypothesized differences between experimental and control groups will use an intent- 
to-treat analysis that includes all participants randomized. LGM will examine the effect of 
treatment condition on trajectories of change separately for each of the outcomes over the 
one-year follow-up. To test Hypothesis 1, we will assess the trajectories of the mothers’ 
outcomes (mental health, physical health, substance abuse, etc.) and predict of the trajectory 
of change by intervention condition (Healthy Home vs. TAU). Controlling for the effects of 
socio-demographic variables and pretest levels of the dependent variables is possible in LGM, 
if these variables are found to differ by randomization group. To test Hypothesis 2, a similar 
procedure will consider children’s outcomes (mental health, physical health, behavior 
problems, etc.). 
 
- Testing mechanisms of action. Using Mplus 6, this set of analyses will investigate links 
between trajectories of change (growth curves) for the hypothesized mechanism of action 
variables (mediators) and trajectories of mothers’ outcomes or children’s outcomes following 
MacKinnon, Lockwood, Hoffman, West and Sheets’ ( 2002) procedures. This method is more 
powerful than the classic (Baron & Kenny, 1986) method, particularly for binary outcomes. 
LGM can also test multiple indirect paths or mediators (i.e., Hypothesis 3c) with this method.  
 
- Clinically significant change procedures (Jacobson & Traux, 1991) can also investigate 
efficacy of an intervention. These procedures: 1) determining whether participants have made 
statistically reliable change and 2) categorizing subjects according to clinically meaningful cut-
points, e.g., recovered (statistically reliable change that moves a client out of clinical range), 
improved (statistically reliable improvement, but still in the clinical range), and 
unimproved/deteriorated.  
 
-Implementation analysis will be used to determine the feasibility of adapting Healthy Home 
for other agencies. Using cost logs for training and service delivery, the total cost of 

implementing Healthy Home can be determined. Therapist and agency satisfaction as well as 
therapist fidelity to Healthy Home will be assessed to determine if changes to the Healthy 
Home implementation protocol are needed. 
 
-Mothers will have additional data from baseline assessments administered by the treatment 
agency: a GAIN-I administered at treatment intake and a GAIN-M90 administered 90 days into 
treatment. As noted in the measures section, several variables (e.g., demographics, history of 
abuse) will be taken from the GAIN-I. There are a number of follow-up analyses that may 
provide greater understanding of the direct and interactive relationships between symptoms, 
intervention, and post-treatment substance use, including adding to growth models of mental 
or physical health and examining moderators of treatment effects. [The GAIN is no longer 
being used in the study] 
 
- Proposed moderators will be used in two types of analyses. The variables might predict 
trajectories of change of the mothers’ and children’s outcomes, only. For example, does poor 
sleep contribute to early relapse for mothers in recovery? The moderators might also interact 
with treatment. For example, do mothers from different ethnic groups respond differently to 
Healthy Home? Effect sizes will be generated for future intervention development/refinement 
from the results of these exploratory analyses.  
- Secondary data analysis will be used to examine data extracted from clinical intervention 
forms related to health assessments, recommendations/referrals, treatment/services 
rendered, follow-up plan of care, and education provided to individuals during home health 
visits.  
 
- Missing data and attrition patterns will be examined. In research with samples of individuals 
in substance use recovery some loss to follow-up is expected. Our proposed methods allow the 
inclusion of cases with randomly missing data, we will test for non-randomness, i.e., a non-
ignorable or informative missing data pattern (Little & Rubin, 1987). If there is differential 
attrition by condition, alternative models will be examined (in addition to the proposed) which 
account for or model the attrition mechanism (Angrist, 1997; Heckman, 1979; Idson & 
Feaster, 1990) to produce a more robust range of estimates. 
 
Privacy/Confidentiality Agreements 
4.13. Describe any privacy agreements or certificates of confidentiality, if applicable.   
We have received a certificate of confidentiality from NIH. 
4d. Description of Study (cont'd) 
Deception 
4.14. * Is the use of deception part of the study design? 
  
Yes 
No 
If yes, please answer the following 3 questions: 
  
4.14.A. Describe in detail the nature of the deception and explain why this is 
necessary for the research. 
 
  
4.14.B. State how, when, and by whom the research subjects will be debriefed. 
 
  
4.14.C. Upload a copy of the debriefing script. 
 

5. Study Participants 
Per 45 CFR 46, human subjects (participants) means a living individual about whom an investigator 
(whether professional or student) conducting research obtains: 
1. data through intervention or interaction with the individual; or 
2. identifiable private information (i.e. pathological specimens, medical records, etc.) 
5.1. * Participant Age:  
 
  
Check all that 
apply 
Notes 
0-6 
Parent Permission/Consent required for each participant 
 
7-17 
Parent Permission/Consent & Child Assent required for each 
participant 
 
18-65 
Consent required for each participant unless a waiver of consent is 
approved by the IRB 
 
65+ 
Consent required for each participant unless a waiver of consent is 
approved by the IRB 
 
  
5.2. For the following questions, please use integers for your responses.  For any question 
that is not applicable, please enter the number 0.  
(Do not enter commas, decimal points or special characters) 
5.2.A. * Maximum number of subjects in the Protocol to be screened at all sites 
(regardless of PI): 
1000 
5.2.B. * Total number of subjects in the Protocol to be studied at all sites(regardless 
of PI):  
800 
University of Miami 
5.2.C. * Maximum number of subjects to be screened by this PI at UM: 
0 
  * Maximum number of subjects to be enrolled by this PI at UM:  
0 
* From the above, how many are expected to complete this study (participate 
in the study beyond initial enrollment?  
0 
Jackson Health Systems 
5.2.D. * Maximum number of subjects to be screened by this PI at Jackson Health 
Systems (JHS): 
0 
 
* Maximum number of subjects to be enrolled by this PI at Jackson Health 
Systems (JHS):  
0 

* From the above, how many are expected to complete this study (participate 
in the study beyond initial enrollment)? 
0 
Miami VA Medical Center 
5.2.E. * Maximum number of subjects to be screened by this PI at Miami VA Medical 
Center: 
0 
  * Maximum number of subjects to be enrolled by this PI at Miami VA Medical 
Center: 
0 
 
* From the above, how many are expected to complete this study (participate 
in the study beyond initial enrollment)? 
0 
5a. Study Populations 
5.3. * Study populations to be included in this study where PI will be conducting research 
and those sites where the UM IRB will have oversight responsibility:  
 
Check all that apply Notes 
Normal, healthy 
volunteers 
  
Children/minors 
(under 18 years of 
age) 
  
Poor/uninsured 
  
Pregnant 
women/fetuses 
Specific Florida statutes apply to prohibit the use of any live fetus or live, 
premature infant for any type of scientific, research, laboratory or other 
kind of experimentation except as necessary to protect or preserve the 
life and health of such fetus or premature infant. 
Outpatients 
  
Wards of the state 
Specific Florida statutes apply to prohibit the enrollment of a minor/adult, 
for whom a guardian has been appointed by the court, in a research 
study without first acquiring the approval of the court having jurisdiction 
of the ward. 
 
  
  
  
5.3.A. If other, please specify: 
 
  
  
5.3.B. Describe below any additional safeguards that have been included to protect 
vulnerable subjects: 
Study candidates will be told that their participation is voluntary, that they may 
withdraw consent at any time, and that their decisions regarding participation will not 
affect their relationship with Banyan or UM.  
 
This study population includes children. With IRB approval and following legally-
established procedures, we plan to enroll children who are wards of the state.  
 
We do not anticipate enrolling prisoners, and subjects who become incarcerated after 
the study begins will not be involved in human subjects activities during their 

incarceration. Participants are also told that if they are on probation or parole there will 
be no special privileges given by the courts because of their participation in the study.  
 
Pregnant women may be enrolled in the study. Interventions are behavioral with some 
minimal physical procedures for assessment, and data collection involves minor physical 
procedures the most invasive of which are collection of urine samples, which pose no 
foreseeable risks to pregnant women, fetuses or neonates. It is possible that some 
pregnant minors (children of the index women) may be enrolled. Children do not have 
any physical procedures in the assessment portion of the study and physical procedures 
in the intervention portion are limited to minimally invasive physical procedures. 
Children age 7 or above will be assented.  
 
We have received a certificate of confidentiality.  
  
5b. Inclusions/Exclusions 
5.4. * Is the population being enrolled in this study at high risk for incarceration? 
  
Yes 
No 
  
  
5.4.A. If yes, will the subjects be withdrawn from the study once they are 
incarcerated? 
  
Yes 
No 
  
  
  
5.4.A.(i) If the above answer (question 5.4.A.) is no, describe how re-
contacting/re-consenting, treatment, and/or follow-up will occur: 
We will not conduct study procedures with participants while they are 
incarcerated but will not withdraw them from the study as they may be 
available to conduct study procedures upon release if they are still within the 
study timepoint windows. If a mother is incarcerated we will attempt to 
conduct follow-up assessments within the appropriate timepoint windows with 
children enrolled in the study if they can be accompanied by an adult family 
member.  
  
NOTE: If a subject becomes incarcerated while enrolled in a study, all research interactions and 
interventions with that subject, and the obtaining of identifiable private information about the 
subject, must cease until the requirements of subpart C have been satisfied with respect to the 
relevant protocol.  
If notified that a previously enrolled research subject has become a prisoner, the principal 
investigator must promptly seek IRB re-review of the protocol in accordance with the 
requirements of subpart C if the principal investigator wishes to have the prisoner-subject 
continue to participate in the research.  In special circumstances in which the principal 
investigator asserts that it is in the best interests of the subject to remain in the 
research study while incarcerated, the IRB Chairperson may determine that the 
subject may continue to participate in the research until the requirements of subpart 
C are satisfied. 
  
5.5. * What are the criteria for exclusion of participants from the research? 
Persons who do not meet the inclusion criteria listed below will be excluded.  

5.6. * Will any population be systematically excluded in this study? 
  
Yes 
No 
  
  
5.6.A. If yes, provide rationale/justification for this exclusion: 
 
 
  
5.7. * What are the criteria for inclusion of participants in the research? 
To be eligible for the study Mothers must meet all of the following 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 (e.g., to accept assignment to either 
condition, to provide sufficient locator information for follow-up, to allow their treatment 
sessions to be monitored for fidelity/process assessment and supervision). 
 
To be eligible for the study Children must meet all of the following criteria: (1) biological, step 
or adopted child of a mother enrolled in the study and with whom the mother has at least 
monthly contact (2) age 2-17, (3) has the signed permission of a legal guardian to enroll in the 
study, (4) gives assent to participate in the study if age 7 or above. 
 
5.8. * Will only one group of individuals be systematically selected and recruited for this 
study (e.g., welfare patients, racial and/or ethnic minorities, persons confined to 
institutions or persons determined to be incapacitated)? 
  
Yes 
No 
  
  
5.8.A. If yes, please state how this participant group will benefit from the results of 
the research and provide the reasons and justifications to target this group: 
This study focuses on women in substance abuse/mental health treatment and their 
children. These groups are at high risk for significant health consequences and there is a 
need for culturally-informed interventions tailored to address their unique needs.  
  
5c. Research Involving Pregnant Women or Fetuses 
Pregnant woman or fetuses may be involved in research if ALL of the following conditions are met 
(all items must be justified): 
  
(a) Where scientifically appropriate, preclinical studies, including studies on pregnant 
animals, and clinical studies, including studies on nonpregnant women, have been 
conducted and provide data for assessing potential risks to pregnant women and 
fetuses. 
* Justification: 
Pregnant women may be enrolled in the study although the study does not specifically target 
pregnant women. Interventions are behavioral with some minimal physical procedures for 
assessment, and data collection involves minor physical procedures the most invasive of which 
are collection of urine samples, which pose no foreseeable risks to pregnant women, fetuses or 
neonates. It is possible that some pregnant minors (children of the index women) may be 
enrolled. Children do not have any physical procedures in the assessment portion of the study 

and physical procedures in the intervention portion are limited to minimally invasive physical 
procedures. 
  
(b) The risk to the fetus is caused solely by interventions or procedures that hold out the 
prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of 
benefit, the risk to the fetus is not greater than minimal and the purpose of the 
research is the development of important biomedical knowledge which cannot be 
obtained by any other means. 
* Justification: 
Interventions are behavioral with some minimal physical procedures for assessment and data 
collection involves minor physical procedures the most invasive of which are collection of urine 
samples, which pose no foreseeable risks to pregnant women, fetuses or neonates. 
 
 
  
(c) Any risk is the least possible for achieving the objectives of the research. 
* Justification: 
Interventions are behavioral with some minimal physical procedures for assessment and data 
collection involves minor physical procedures the most invasive of which are collection of urine 
samples, which pose no foreseeable risks to pregnant women, fetuses or neonates. 
  
(d) If the research holds out the prospect of direct benefit to the pregnant woman, the 
prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect 
of benefit for the woman nor the fetus when risk to the fetus is not greater than 
minimal and the purpose of the research is the development of important biomedical 
knowledge that cannot be obtained by any other means, her consent is obtained in 
accord with the informed consent provisions of subpart A of this part. 
* Justification: 
Interventions are behavioral with some minimal physical procedures for assessment and data 
collection involves minor physical procedures the most invasive of which are collection of urine 
samples, which pose no foreseeable risks to pregnant women, fetuses or neonates. 
  
(e) If the research holds out the prospect of direct benefit solely to the fetus then the 
consent of the pregnant woman and the father is obtained in accord with the informed 
consent provisions of subpart A of this part, except that the father's consent need not 
be obtained if he is unable to consent because of unavailability, incompetence, or 
temporary incapacity or the pregnancy resulted from rape or incest. 
* Justification: 
NA 
  
(f) Each individual providing consent under paragraph (d) or (e) of this section is fully 
informed regarding the reasonably foreseeable impact of the research on the fetus or 
neonate. 

* Justification: 
NA. Interventions are behavioral with some minimal physical procedures for assessment and 
data collection involves minor physical procedures the most invasive of which are collection of 
urine samples, which pose no foreseeable risks to pregnant women, fetuses or neonates. 
  
(g) For children as defined in §46.402(a) who are pregnant, assent and permission are 
obtained in accord with the provisions of subpart D of this part. 
* Justification: 
Children who are pregnant may be enrolled if they are the child of the index mother. Children do 
not have any physical procedures in the assessment portion of the study and physical 
procedures in the intervention portion are limited to minimally invasive physical procedures. 
Assent and parental or guardian permission will be obtained. 
  
(h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy. 
* Justification: 
No inducements whatsoever will be offered to terminate a pregnancy. 
  
(i) Individuals engaged in the research will have no part in any decisions as to the timing, 
method, or procedures used to terminate a pregnancy. 
* Justification: 
Research staff will have no part in any decisions as to the timing, method, or procedures used to 
terminate a pregnancy. 
  
(j) Individuals engaged in the research will have no part in determining the viability of a 
neonate. 
* Justification: 
Research staff will have no part in determining the viability of a neonate. 
5f. Research Involving Minors 
* Pick ONE category below:  
 
  
Select one 
 
§46.404 Research not involving greater than minimal risk. 
HHS will conduct or fund research in which the IRB finds that no greater than 
minimal risk to children is presented, only if the IRB finds that adequate provisions 
are made for soliciting the assent of the children and the permission of their parents 
or guardians. 
 
§46.405 Research involving greater than minimal risk but presenting the prospect of 
direct benefit to the individual subjects. 
HHS will conduct or fund research in which the IRB finds that more than minimal risk to 
children is presented by an intervention or procedure that holds out the prospect of direct 

benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the 
subject's well-being, only if the IRB finds that: 
a. The risk is justified by the anticipated benefit to the subjects; 
b. The relation of the anticipated benefit to the risk is at least as favorable to the subjects 
as that presented by available alternative approaches; 
c. 
 
Adequate provisions are made for soliciting the assent of the children and permission of 
their parents or guardians. 
 
§46.406 Research involving greater than minimal risk and no prospect of direct 
benefit to individual subjects, but likely to yield generalizable knowledge about the 
subject's disorder or condition. 
HHS will conduct or fund research in which the IRB finds that more than minimal risk to 
children is presented by an intervention or procedure that does not hold out the prospect of 
direct benefit for the individual subject, or by a monitoring procedure which is not likely to 
contribute to the well-being of the subject, only if the IRB finds that: 
a. The risk represents a minor increase over minimal risk; 
b. The intervention or procedure presents experiences to subjects that are reasonably 
commensurate with those inherent in their actual or expected medical, dental, 
psychological, social or educational situations; 
c. 
The intervention or procedure is likely to yield generalizable knowledge about the 
subjects' disorder or condition which is of vital importance for the understanding or 
amelioration of the subjects' disorder or condition; 
d. Adequate provisions are made for soliciting assent of the children and permission of 
their parents or guardians. 
 
§46.407 Research not otherwise approvable which presents an opportunity to 
understand, prevent, or alleviate a serious problem affecting the health or welfare of 
children. 
 
 
  
* Justify each criterion within the category chosen above: 
Children do not have any physical procedures in the assessment portion of the study and physical 
procedures in the intervention portion are limited to minimally invasive physical procedures which 
pose no foreseeable risks. Procedures with children do not constitute risk above and beyond what 
children encounter in everyday life. 
NOTE: HHS will conduct or fund research that the IRB does not believe meets the requirements of 
§46.404, §46.405, or §46.406 only if: 
A. The IRB finds that the research presents a reasonable opportunity to further the 
understanding, prevention, or alleviation of a serious problem affecting the health or welfare 
of children; and 
B. The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: 
science, medicine, education, ethics, law) and following opportunity for public review and 
comment, has determined either: 
1. that the research in fact satisfies the conditions of §46.404, §46.405, or §46.406, as 
applicable, or 
2. the following: 

i. 
The research presents a reasonable opportunity to further the understanding, 
prevention, or alleviation of a serious problem affecting the health or welfare 
of children; 
ii. 
The research will be conducted in accordance with sound ethical principles; 
iii. 
Adequate provisions are made for soliciting the assent of children and the 
permission of their parents or guardians, as set forth in §46.408. 
6. Subject Recruitment 
6.1. * From what sources or by what methods will subjects be recruited? 
 
Check all that apply 
Flyers/newsletters 
Internet (web postings) 
Contact letters (physicians, teachers, etc.) 
Outpatients/clinics 
Medical records 
Direct contact 
Mass e-mail solicitation 
Telephone 
 
   
  
6.1.A. If postings within hospital, please indicate name of facility: 
 
  
  
6.1.B. If emergency room, please indicate name of facility: 
 
  
  
6.1.C. If other, please specify: 
 
6a. Subject Recruitment (cont'd) 
6.2. * Provide a step-by-step description of the recruitment procedures used to identify 
and/or contact prospective participants: 
Mothers will be recruited from substance abuse/mental health treatment sites run by Banyan. 
Study staff employed by Banyan will invite all women who are enrolled in outpatient substance 
abuse, mental health (or co-occurring) treatment and who have children ages 0-17 to 
participate in the study. Study staff will contact candidates up to 4 times to offer study 
enrollment. Candidates who express interest in participating will be administered a screening 
interview by phone or in person. Study staff will explain the study and if the mother agrees to 
participate she will be read and asked to provide signed consent and permission for her children 
to participate.  
 
In addition, study personnel will reach out to personnel from sites that refer women to Banyan 
for outpatient substance abuse or mental health treatment. This includes Banyan-affiliated 
residential substance abuse treatment sites, Family Intervention Services, the drug courts and 
other venues. The study team members will talk to personnel of those sites about the study and 

provide them with IRB-approved study flyers and pamphlets and ask them to distribute these 
materials to mothers who might be referred to Banyan for outpatient substance abuse 
treatment. Study staff will ask local agencies that serve women who receive mental health or substance abuse 
treatment to provide contact information for their clients who have consented to be called regarding the study. Those 
women will be called by study staff for recruitment to the study. We will also use social media (e.g., 
Craigslist) to broadcast information about the study as a means of promoting recruitment. 
Potential participants will have to call the study number - there will be no direct communication 
with individual study candidates via social media. 
 
In addition, the study will accept self-referrals from women who are receiving substance abuse, 
mental health (or co-occurring) treatment at other centers (besides Banyan). Study staff will 
inform staff at substance abuse/mental health treatment center about the study and will 
provide them with flyers and pamphlets. Staff from the substance abuse/mental health 
treatment center will post/distribute flyers/pamphlets and those clients who are interested will 
contact the study.  
 
After obtaining the mother's informed consent to enroll in the study, study staff will administer 
the Child ID Form to identify children who are eligible to participate.  
  
  
6.2.A. Please upload copies of scripts, recruiting materials, and advertisements: 
 
Name 
Description 
Version 
20111132_ADV_IRBApp_HealthyHomeFlyer_ENG 
  
0.04 
20111132_ADV_IRBApp_HealthyHomeFlyer_SPA 
  
0.03 
20111132_ADV_IRBApp_HHBrochure_ENG 
  
0.05 
20111132_ADV_IRBApp_HHBrochure_SPA 
  
0.04 
ChildID_translation.doc 
  
0.02 
Healthy Home Tear Off Flyer English.docx 
  
0.03 
Healthy Home Tear Off Flyer Spanish.docx 
  
0.03 
Mother's Screening Form_translation.doc 
  
0.02 
Treatment assignment Postcard with Translation.docx 
  
0.01 
 
  
 
NOTE:  Any materials that will be given to or seen by potential subjects must be 
reviewed and approved by the IRB.  This includes assessments, instruments, diaries, 
questionnaires, and all screening and recruitment materials, including advertisements, 
web postings, letters, and telephone scripts. Only IRB approved versions of these 
materials may be used during the course of the study. 
6.3. * What measures will be taken during the recruitment process to safeguard against 
the potential coercion or the appearance of coercion of participants, particularly 
vulnerable populations? 
Study candidates will be told (verbally and in writing) that their participation is voluntary, that 
they may withdraw consent at any time, and that their decisions regarding participation will not 
affect their relationship with Banyan.  
6.4. * Are there specific criteria to prematurely end a particular subject's participation in 
the study (e.g., predetermined safety endpoints, unexpected clinically significant 

findings, distress or serious adverse events, etc.)? 
 
  
Select one 
Yes 
No 
Not Applicable 
 
 
  
6.4.A. If yes, please describe: 
 
6.5. * Will subjects be remunerated for their participation in the study in any way other 
than credit toward a course requirement? 
  
Yes 
No 
  
6b. Remuneration 
6.5.A. * List type, frequency, interval, and total value of remuneration: 
 
  
Type of 
Remuneration Frequency Total Value 
View Cash 
4 
Mothers will be paid $50 per assessment interview. Mothers 
will receive a $20 bonus if all of her enrolled children attend. 
View Gift 
Certificates 
4 
Children will receive a $10 (age 10-12) or $20 (age 13-17) gift 
card. Mothers will receive a giftcard with a value of $20. to 
encourage participation in the first intervention visit. Those 
mothers who are assigned to the Healthy Home condition will 
receive the gift card at their first home visit. Those who are 
assigned to TAU will receive the gift card at their next follow up 
assessment. For participants who enrolled in the study before 
the gift card procedure was approved, those in Healthy Home 
who have already been terminated from the intervention will 
receive the gift card at their next assessment.  
 
  
6.5.B. * If a subject withdraws from the study early, will remuneration be prorated? 
yes 
  
  
6.5.B.(i) If yes, describe plan for prorating payments and ensure that this plan is 
defined in consent forms: 
Participants will be remunerated for assessments that they attend and 
complete.  
  
  
  
6.5.B.(ii) If no, justify why prorated payment is not being offered: 
 
  

6c. Financial Liability 
6.6. * Financial Liability for Study Participants: 
Complete the table below, indicating the responsible party for payment of research activities 
and procedures. 
Not applicable 
  Procedure or Activity 
Frequency 
 There are no items to display 
 
  
6.7. * Select all categories indicating costs which participants or their insurance 
companies will be responsible for: 
 
  
Check all that apply 
Participants will have no costs associated with this study 
Study-related procedures which would be done under standard care 
Study-related procedures not associated with standard care 
Administration of drugs/devices 
Study drugs 
Study devices 
Other 
  
6.7.A. If other, please specify: 
The study does not cover costs to participants for the outpatient substance 
abuse treatment (they are already enrolled in substance abuse treatment 
when they enroll in the study) or costs associated with referrals made by the 
Healthy Home nurse.  
6.8. * In the event of study-related subject injury, who will be responsible for 
compensation? 
Not Applicable 
  
6.8.A. If Other 3rd Party, please specify: 
 
7. Informed Consent 
7.1. * Is an alteration of the consent process being requested? 
  
Yes 
No 
 
NOTE:  "Alteration of consent" is when the consent procedure does not include, or alters, some 
of the required elements of informed consent.  This only applies to studies conducted by state 
or local government on public benefit or service 
programs.  See http://www.hhs.gov/ohrp/humansubjects/assurance/consentckls.htm 

7.2. * Is a waiver of informed consent being requested? 
  
Yes 
No 
 
NOTE: This indicates there is no consent process; waiver criteria need to be justified. 
7.3. * Is a waiver of signed consent being requested? 
  
Yes 
No 
NOTE: This indicates that the consent process will occur, but there is no signed consent (i.e., 
verbal script or consent letter). 
7b. Informed Consent (cont'd) 
7.8. * Under which of the following criteria does this research qualify for Waiver of Signed 
Consent? 
 
  
Check one Description 
 
45 CFR 
46.117 (c) 
(1) 
The only records linking the subject and the research would be the consent 
document, and the principal risk would be the potential harm resulting from a 
breach of confidentiality. Each subject will be asked whether the subject wants 
documentation linking the subject with the research, and the subject’s wishes 
will govern. 
 
45 CFR 
46.117 
(c) (2) 
This research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written consent is normally 
required outside of the research context. 
 
 
 
  
  
7.8.A. * Please state the justification for the criterion selected above: 
We are requesting a waiver of signed consent for screening. The questions asked for 
the mother's screening are innocuous - e.g., her age, whether she has minor children, 
whether she has monthly contact with any of those children.  
  
7c. Informed Consent (cont'd) 
7.9. * Describe the specific steps for obtaining informed consent (e.g., by whom, his/her 
credentials, language, where, when, etc.): 
Not applicable 
CITI certified study staff will explain the study to the mother and if she agrees to participate 
she will be asked to provide signed consent and permission for her eligible children to 
participate.  
7.10. Consent may be required from a parent, legal guardian, legal representative, court-
appointed representative, or health care surrogate where research involves 
children/minors, wards of the state, cognitively or developmentally impaired 
individuals, comatose or traumatized or emergency subjects, as well as any other 
subjects lacking capacity to consent. Such surrogate/representative/guardian can 
only consent if the IRB has approved the research under HHS or FDA regulations. For 
court-appointed guardians, court assent is required. 

If your study involves any of these groups, please specify below whether consent 
will be obtained from such surrogate/representative/guardian and describe the 
process for obtaining such consent: 
Mothers will be asked to provide permission for their childrens' participation. In cases where a 
person other than the mother has legal custody of the child, that person will be asked for 
signed permission. If there are wards of the state, the court-appointed designee would have to 
provide legally effective consent. Children age 7 or above will have the study explained and 
asked to give assent when they attend the baseline appointment. 
7.11. * What protections will be offered to persons with cognitive impairment or to 
persons determined to be incapacitated?  Describe how capacity for consent will be 
determined, whether cognitive capacity is expected to change significantly during 
the study, whether a legally authorized representative or health surrogate  has been 
designated for purposes of obtaining informed consent, and whether court approval 
has been obtained (for court-appointed guardians).  Describe plans to re-consent 
subjects after a change in the subject's cognitive capacity. 
Not applicable 
 
7.12. * How will informed assent for children and parental consent/permission be 
obtained? 
Not applicable 
Mothers will be asked to provide permission for their childrens' participation. In cases where a 
person other than the mother has legal custody of the child, that person will be asked for 
signed permission. Children age 7 or above will have the study explained and asked to give 
assent when they attend the baseline appointment. 
   
7.13. * Describe plans to re-assent or obtain consent for child subjects during the study if 
the subject reaches the age of majority (18 years) or if there is a significant change 
in cognitive capacity (i.e. gets older or regains consciousness). 
Not applicable 
Children who reach age 18 during the study will be consented at the next study visit.  
   
  
7.14. * How will non-English speaking participants be consented?  (Federal regulations 
require the equitable selection of minorities as research subjects to assure that they receive 
an equal share of the benefits of research and to ensure that they do not bear a 
disproportionate burden.) 
 
  
Check one 
Notes 
Not Applicable 
  
 
A translated written informed 
consent document in a language 
understandable to the participant 
This should be an accurate translation of the 
IRB-approved English version of the full 
informed consent document. Translations of 
IRB-approved informed consent documents 
must be made by a certified translator. 
Click here for list of certified translators. 

 
Orally, using a qualified translator to 
translate the English informed 
consent document to the participant, 
and a translated short form in a 
language understandable to the 
participant. 
See IRB Policy IV.B. "Documentation of Informed 
Consent" 
 
 
7.15. * Informed Consent Document Templates 
Not applicable 
 
Please attach all consent and assent templates associated with this study.  (This 
includes genetic consent, HIV consent, tissue banking consent, etc.) 
 
Name 
Description Version 
20111132_ICF_IRBApp_Assent_Main_ENG 
  
0.01 
20111132_ICF_IRBApp_Assent_Main_SPA.doc 
  
0.06 
20111132_ICF_IRBApp_Assent_Pilot_ENG.doc 
  
0.01 
20111132_ICF_IRBApp_Assent_Pilot_SPA.doc 
  
0.01 
20111132_ICF_IRBApp_ConsentMotherNotLegalGuardian_SPA.doc 
  
0.02 
20111132_ICF_IRBApp_ConsentParentalPermission_Main_SPA.doc 
  
0.02 
20111132_ICF_IRBApp_ConsentParentalPermission_Pilot_ENG.doc 
  
0.02 
20111132_ICF_IRBApp_ConsentParentalPermission_Pilot_SPA.doc 
  
0.02 
20111132_ICF_IRBApp_FamilyVisits_SPA.doc 
  
0.02 
20111132_ICF_IRBPApp_ConsentMotherNotLegalGuardian_Main_ENG.doc   
0.01 
20111132_ICF_IRBPApp_ConsentParentalPermission_Main_ENG.doc 
  
0.01 
20111132_ICF_IRBPApp_FamilyVisits_ENG.doc 
  
0.01 
 
  
  
8. Protected Health Information 
Protected health information (PHI) is individually identifiable health information that is or has been 
collected or maintained by the University of Miami or JHS or created for purposes of providing 
medical care/treatment and can be linked back to the individual participant. 
  
8.1.(a) * Will Protected Health Information (PHI) be accessed (used or created for 
treatment) prior to contact with subjects in this research? 
  
Yes 
No 
  
  
 8.1.(b) * Will PHI be accessed (used or created for treatment) during the course of the 
proposed research? 
  
Yes 
No  

11. Use of Human Biological Samples 
11.1. * List all samples to be used in this research: 
 
  
Type of sample 
View Urine samples will be used to test for drug toxicology analysis. 
 
  
  
11.2. * Will it be possible, if so requested, to provide the participant with the sample/data 
for this study? 
no 
  
11.2.A. If no, please explain: 
We are not retaining any biological samples, therefore we will not be able to 
provide them to the participants.  
11.3. * Will you allow participants to request the samples/data in this study be destroyed? 
no 
  
11.3.A. If no, please explain: 
We are not retaining any biological samples, therefore this is NA. 
15. Conflict of Interest 
As the Principal Investigator, you must be aware of any conflict of interest of the protocol team or 
institution.  Please note that the thresholds of ownership described below apply to the aggregate 
ownership of each individual investigator (or other key personnel, to the best of their knowledge) 
and their immediate family. The immediate family includes each investigator's spouse, domestic 
partner and dependent children (e.g., if an investigator together with his/her spouse, domestic 
partner and dependent children own a total of $10,000 or 5% worth of equities in the sponsor, it 
should be reported below). 
"Conflicts of interest" apply to each investigator or other individuals listed as key personnel. Do not 
consider the combined ownership of all investigators/key personnel.  Do not consider compensation 
for the % effort on a study. 
 
15.1. * Does any person obtaining consent have any existing relationship (family, social, 
or professional, including physician-patient or student-teacher) with the 
subject(s)? 
  
Yes 
No 
  
  
15.1.A. If yes, describe the relationship(s) and how subjects will be protected 
against undue influence or coercion: 
 
 
  
15.2. * Will there be any programs, bonuses, rewards or other incentives that may be 
offered to this site and/or its faculty or staff by the sponsor or others for rapid 
enrollment?  
  
Yes 
No 
  

  
15.2.A. If yes, please describe: 
 
 
Note: Before accepting any awards, the IRB must be informed of the nature and value of these 
incentives. 
 
  
15.3. * Do any of the investigators or members of their immediate families receive from 
the sponsoring entity salaries, consulting fees, or other compensation for services 
that exceed $10,000 in any twelve month period? (Note: if the sponsoring entity is 
the full time employer of the investigator, co-investigator or key personnel (i.e. UM or JHS) 
then answer "No."   Do not consider compensation for the % effort on a study.") 
  
Yes 
No 
 
  
15.4. * Do any of the investigators or members of their immediate families serve as an 
officer, director, or as a member of any advisory board with the sponsoring entity? 
  
Yes 
No 
 
  
15.5. * Do any of the investigators or members of their immediate families have an 
equity interest that exceeds $10,000 in value or represents more than 5% 
ownership in the sponsoring entity? 
  
Yes 
No 
 
  
15.6. * Do any of the investigators or members of their immediate families have any 
intellectual property rights (patents, copyrights, royalties) in any article(s), 
product(s), drug(s), device(s) or other material(s) that will be involved in this 
research? 
  
Yes 
No 
 
  
15.7. * Do any of the investigators or members of their immediate families have any 
other financial interest or relationship that would reasonably be affected by this 
research? 
  
Yes 
No 
 
  
15.8. * Do any of the investigators or others know of any institutional conflict of interest 
pertaining to this study? 
  
Yes 
No 
  
15.8.A. If yes, please describe: 
 
15.9. * Has any of the technology used in the study been developed in whole or in part 
at the University of Miami? 
  
Yes 
No 

16. Monitoring Plans 
16.1. * Select the item below that most accurately reflects the plan for data and safety 
monitoring for this study: 
 
  
Select one 
The study will be monitored only by the study investigators and/or sponsor. 
 
The study will be monitored by at least one individual who is not associated 
with the study, but not by a formally constituted Data and Safety Monitoring 
Board (DSMB). 
A formally constituted Data and Safety Monitoring Board (DSMB) will monitor the study. 
Not applicable 
 
 
16.2. Has an internal (UM or JHS) data safety monitor or board/committee been 
established to provide additional oversight or monitoring of this study for safety and 
adherence to the study protocol?  
  
Yes 
No 
  
  
16.2.A. If yes, describe the composition of the committee and how they will 
communicate findings to the IRB: 
 
  
16.3. Has an external (non-UM or JHS) data safety monitor or board/committee been 
established to provide additional oversight or monitoring of this study for safety and 
adherence to the study protocol?  
  
Yes 
No 
  
  
16.3.A. If yes, describe the composition of the committee and how they will 
communicate findings to the IRB: