Steps to Effective Problem Solving in Group Homes for Individuals With Intellectual Disabilities
Phase: NA
Conditions: Problem Behavior
Sponsor: Rush University Medical Center

Study Protocol and Statistical Analysis Plan 
 
For 
 
Steps to Effective Problem-solving (R01HD086211) 
 
NCT02855008 
 
April 8, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. RESEARCH STRATEGY 
B1. Significance 
Intellectual disability (ID) affects 1%-3% of the 312 million U.S. population (3-10 million),23,24
 
over 85% of 
whom have mild to moderate ID. 
 
Members of this population often have aggressive/challenging behaviors 
(A/CBs)15.
 
A/CBs (including physically or verbally aggressive, destructive, socially offensive, or other 
behaviors) pose a risk to the health and safety or negatively affect the quality of life of individuals with ID or 
others and require management.26
 
Epidemiologic studies show that, among individuals with ID, A/CBs are 
more of a problem among males. 27A/CBs also may be an atypical feature of depression in this 
population.28Rates of depressive symptoms are as high as 28%-39% in individuals with ID,29-31
 
and more 
common among females.32
 
A/CBs are also associated with adverse life events common among residents of 
group homes such as the death of a parent, family member, or an individual important in one’s life.33-34
 
Despite their cognitive deficits, evidence indicates that A/CBs are modifiable for persons with this disability. 
B1a. Deficits in social problem solving. Evidence suggests that individuals with ID are susceptible to 
A/CBs due to deficits in social problem solving (SPS).7,27
 
SPS is the process of finding solutions to problems. It 
includes the cognitive and behavioral activities one uses to recognize, cope with, and find solutions to 
problems. SPS is made up of two independent but interrelated dimensions: attitude and style.6
 
The dimension 
of attitude includes positive and negative attitudes. Positive attitude involves recognizing problems and their 
sources, and believing in one’s ability to manage or solve problems. Negative attitude involves thinking of 
problems as a threat, inaccurately describing their sources, and believing that one is unable to solve or 
manage the problems.6 Individuals with ID who have A/CBs tend to have a negative attitude; they are more 
likely to view interpersonal situations as hostile.7,27 
The three SPS styles are rational, avoidant, and impulsive. Defining problems, generating and thinking 
through alternatives, and systematically carrying out and verifying solutions are part of the rational problem- 
solving style.6
 
Inaction, dependence, and passivity toward problems are part of the avoidant style. Immediate 
emotional responses to problems are part of the incomplete, hurried, and careless impulsive style of SPS. 
Individuals without aggression problems use more assertive responses (rational style)7,27.
 
Individuals with ID 
who have A/CBs respond to situations with hostile actions more frequently than non-aggressive individuals 
with ID,7 and, in stressful situations, use more aggressive responses (impulsive style)27 
B1b. AC/Bs and the group home. A/CBs of individuals with ID living in group homes represent an 
important public health issue in an under-researched and under-treated vulnerable population. A/CBs 
directed to self, other residents, and staff are reportedly common in group homes and a major concern for 
residential staff,18,36
 
who report witnessing A/CBs at least several times a week.18,36
 
Also, 20%-24.5% of 
individuals with ID in group homes report experiencing distress from other residents’ A/CBs.16,37 Such 
behaviors increase problematic interactions, perpetuating the problem.16,37
 
Punitive means of handling A/CBs 
(e.g., physical and/or chemical restraints, timeouts) can be as dangerous and are unacceptable in terms of 
human rights.38.39
 
To reduce and eliminate the use of such methods, agencies providing residential services 
for individuals with ID are encouraged to follow a system of positive behavioral support.40 SPS interventions 
show effects in reducing problem behaviors, but have never been tested in a clinical trial as a preventive 
intervention in the community, including group homes and work settings. A critical need exists for evidence-
based behavioral interventions that can be implemented as part of positive behavior support to reduce A/CBs. 
B1c. Lessons learned from SPS interventions. Our pilot intervention used SPS training among 
individuals with ID and their residential staff as a preventive intervention to address A/CBs in a community 
setting. The intervention systematically involved support staff and the group environment to enhance the 
intervention. Our pilot was specifically designed to incorporate strengths found in previous research and to 
address gaps in previous efforts. (1) Over the past 25 years, almost all SPS studies were conducted in clinical 
and forensic settings and with individuals with ID referred for severe behavior and anger management 
problems, necessitating delivery by highly trained psychologists and graduate students, making the 
interventions expensive41-47
 
Studies found improvement in SPS skills, including use of rational style 
(specifically generation and quality of alternative solutions) and a decrease in impulsive style and anger 
provocation.41-47 Improved SPS was demonstrated by self-report and coded digital audio- and videotapes,
 
and 
reduced A/CBs were demonstrated by self-report, caregiver report, and role-play measures.41-47Reductions 
were maintained for up to 12 months. Our pilot developed a SPS intervention specifically as a preventive 
intervention. (2) Two studies suggested that outcomes were better for individuals who had a staff member 
accompany them, but staff were not included as an integral part of the interventions.
 
Our study systematically 
involved staff. (3) The support environment for SPS is an important consideration.42,47 In addition to residential 
staff support, group training in SPS skills may encourage individuals with ID to think about the point of view of 
others and identify alternatives for problem solutions.48
 
Research showed that when individuals with mild or 
moderate ID living in residential facilities made decisions as a group about common problems, the decision-
making skills of the individuals improved.49 Factors in the group environment, such as group cohesiveness, 
have been shown to affect outcomes.50 Our pilot intervention specifically used the support environment of the 

group home to help individuals with ID maintain and use social problem-solving skills and thus prevent 
problem behaviors. Previous studies did not provide a path to sustainability. Our interventionists have 
qualifications similar to qualified ID professionals (QIDPs), who currently provide services to individuals with ID 
in group homes. QIDPs have bachelor's degrees in a human services field (e.g., sociology, special education, 
rehabilitation counseling) and at least one year of experience with individuals with ID.51This will provide 
evidence about whether QIDPs could carry out the STEPS intervention in practice. 
Additional gaps in the current literature were identified in a recent Cochrane review of randomized or 
quasi- randomized interventions for outwardly aggressive behavior among individuals with ID.52
 
Only four 
studies met the review criteria; of these, three included SPS training.42,44,45
 
The review concluded that 
previous studies all had a moderate risk of selection bias and lacked intent-to-treat analysis. The review 
recommended larger randomized trials with objective outcome measures of aggressive behavior and cost-
effectiveness analysis.52
 
Other gaps included that no studies assessed outcomes across community and 
work settings. 
We will address prior gaps by conducting a randomized clinical trial in a community setting (group home) 
with objective outcome measures of A/CBs in the group homes and in work settings. We also will conduct a 
cost-effectiveness analysis. We will implement the STEPS intervention in group homes with residents with ID 
and residential staff and investigate the mediating effect of the support environment for SPS (residential staff 
SPS, group SPS, and group cohesiveness) on the intervention outcomes. We will use an intent-to-treat 
approach, will evaluate efficacy using multiple measures of A/CBs, including objective measures. By 
addressing these gaps, we will provide empirical data on the efficacy of SPS training and effects in the 
prevention of A/CBs in individuals with ID. 
B1d. Conceptual framework. We will use the STEPS Framework, developed in our pilot study (B3a).
21,22 
The STEPS Framework (Figure 1) is based on the Interaction Model of Client Health Behavior
53,54 
and the 
Relational/Social Problem-Solving Model.
6 
These models are grounded in the broad philosophic construct of 
human agency that addresses the capacity of humans to adapt, change, make choices, and make things 
happen by their own actions.
55 
The STEPS Framework allows one to examine explanatory relationships 
among determinants of the A/CBs of individuals with ID, intervention strategies, the support environment for 
SPS,   and subsequent outcomes (SPS skills and A/CBs). A/CB determinants are characterized by 
background characteristics (demographics, past life events, environment, and current health). A/CBs are 
associated with SPS attitude and style, specifically negative attitude and impulsive style. STEPS intervention 
strategies are targeted to SPS skills, specifically to increase positive attitude and rational SPS style. The 
STEPS intervention 
affects relationships between background 
characteristics and outcomes of SPS skills 
and A/CBs. Targeting SPS skills for 
improvement can reduce A/CB outcomes. 
The support environment for SPS mediates 
the relationship between the intervention and 
individuals with ID outcomes. The framework 
specifies that participant outcomes (i.e., SPS 
and A/CBs) are dynamically related: the 
greater the improvement of SPS skills, the 
greater the likelihood of decreased A/CBs. 
B2. Innovation 
The STEPS intervention is a prevention- 
oriented approach to reducing A/CBs for individuals with ID. We created a unique adaptation of an existing  
SPS skills-building program by translating it from the clinical setting to group homes in the community, an 
environment ideal for preventive interventions. Our proposed study takes this further by using interventionists 
with similar backgrounds to QIDPs who work providing residential services. We will conduct cost-effectiveness 
analysis providing a new means to quantify the costs of A/CBs to individuals with ID, their support systems, 
and society. We will provide a robust means to address the impact of the intervention on costs. If the 
intervention proves successful, next will be conducting implementation research to address whether QIDPs 
can conduct SPS training with individuals with ID and residential staff in group homes with the support of 
agency management. Doing so will demonstrate a mechanism for delivering STEPS in the community in a way 
that relies on staff usually in these settings rather than requiring additional professionals. If these innovations 
are successful, it will provide an innovative model of sustainable cost-effective care for this population. 
B3. Approach 
B3a. Preliminary Studies 
Developing a SPS program for the group-home environment (PI Ailey, S., Co-I Miller, A. Rush CON 
Pilot Funding, 2010-2011).21,22The purpose of this study was: (1) Phase 1: modify and tailor Nezu and 
colleagues’ Attitude, Define, Alternatives, Predict and Try-out (ADAPT) social problem-solving program 6so 
that it was understandable and acceptable for individuals with ID in group homes and their residential staff, 
Support Environment for SPS 
•Residential staff  •Group SPS 
SPS 
•Group cohesiveness 
STEPS 
Training in SPS 
skills to Increase 
attitude 
•Positive attitude 
•Rational style 
Aggressive/Challenging 
Behavior Determinants 
SPS 
•Attitude 
Positive 
Negativ
e 
•Style 
Impulsiv
e
Participan
t 
SPS skills 
•Attitude 
•Style 
 
A/CBS 
Assessment 
Baseline 
Intervention 
0-12 
Outcomes 
Weeks12, 24, 
Background – Past and 
Current 
Demographi
Environment 
Current 
 
•Depressive symptoms 
•Medication management 
Figure 1: Steps to Effective Problem-Solving (STEPS) Framework 

and (2) Phase 2: pilot test feasibility of the newly adapted program (now called STEPS).21 
Methods Phase 1: In previous work, we found the views of individuals with ID differed from those of their 
support staff and caregivers.29,56.57
 
Also, translating clinical research to community settings includes obtaining 
input from community members on how they understand materials and how they would like interventions 
delivered.58
 
Thus, in this study we used multiple sequential methods and sought input from four groups of 
important stakeholders. First, a panel of experts, including the PI, co-I (a counseling psychologist), and Dr. 
Nezu, made modifications to the ADAPT program manual. Second, an advisory committee of six agency 
program directors (responsible for developing behavioral programs for individuals with ID) from four agencies 
providing residential services met with the PI to review the revised manual and recommend additional 
changes. Third, the new program manual was reviewed with three individuals with ID who lived in group homes 
and     had a history of A/CBs requiring behavior program plans. Cognitive interviewing was used.59,60
 
Fourth, 
the program was reviewed with three group-home residential staff using cognitive interviewing. After all 
cognitive interviews were complete, the expert panel and a methodological consultant (Dr. Janet Melby) met 
again to edit and approve the program that was used during the pilot in Phase 2. Based on experience during 
the pilot and satisfaction interviews with residents and residential staff who participated, further modifications 
were made     to the program. The same three individuals with ID who participated in the cognitive interviews 
reviewed the modifications. The STEPS program was then finalized. 
Results Phase 1:
21 
Reviewing the initial modification of the ADAPT program manual, the Advisory 
Committee of agency program directors recommended reducing the number of sessions from 12 in the 
original to 6. They also suggested the need for interactive group materials and activities to build group 
cohesiveness. The cognitive interviews with individuals with ID provided examples of problems likely to lead 
to A/CBs and ways the individuals might respond, alternative wording, and ideas for the logistics of the 
program. Residential staff expressed confidence in working with the program, provided suggestions for 
interactive games, and suggested the use of narrated PowerPoint slides to reinforce the material in the 
manual. The expert panel, in consultation with the advisory committee, made modifications to the program 
throughout the process. We distilled the program to the core elements (attitude, define, alternatives, predict, 
tryout). Further, we simplified language to be comprehended by persons with ID (aimed for 2
nd 
grade 
comprehension level). Group members knew one another so time to build familiarity was reduced. Thus, we 
could reduce the modules from 12 to 6.22 
 
Methods- Phase 2:
22 
A pre-post design was used to test STEPS. One agency identified two group homes 
(one male, one female) with a history of A/CBs. Of the 14 residents in the two homes, 12 agreed to 
participate; of these, 9 required consent of a legal guardian. Six residential staff signed consents to 
participate, and four actually participated. A Data and Safety Monitoring Committee reviewed data and 
protocols during the pilot. 
The psychiatric nurse interventionist and a research assistant were trained in the intervention. The six weekly 
sessions and one booster of the STEPS program were delivered over 12 weeks. Outcomes measured pre 
and post intervention were SPS skills of the individuals with ID and residential staff, group-level problem 
solving, and A/CBs of individuals with ID.
42,50,61-62
 
Results Phase 2: The mean age of individuals with ID was 36.6 (SD 10.5). All 4 residential staff and 5 of 
the 12 individuals with ID were women. Half of residential staff (50%) and 25% of individuals with ID were 
minorities. Among residents, 33% had incident reports during the previous 12 weeks. On average, the 
individuals with ID attended 70% of the sessions and residential staff attended 67%. One individual with ID 
dropped out over the 12 weeks due to lack of interest, one staff member went to a different home, and 
another staff member left the employ of the agency midway through the study. Satisfaction was high among 
individuals with ID and residential staff (91% and 87% highly satisfied, respectively). The effect size for 
improvement in SPS skills was d = .60 for individuals with ID and residential staff. The effect size for decrease 
in A/CBs of individuals with ID was d = .60. Effect sizes for improvement were d = .51 in group-level problem 
solving and d= 1.43 in cohesiveness (first session to last). 
22
 
Residential staff indicated that training in breaking down problems and getting to know how individuals 
with ID related to each other were the most helpful aspects of the program. They suggested that because 
some issues are “touchy” for group discussion, sessions should start with “easier” issues and move to 
increasingly difficult topics. They wanted guidance on the program and more guidance for practice between 
sessions. Both individuals with ID and residential staff felt the best time to meet was a weekday evening. 
Implications for the proposed study: We were successful in recruiting and retaining individuals with ID and 
their residential staff. Satisfaction was high for both. There was a medium-to-large effect size, indicating 
improved SPS skills and 

decreased A/CBs in a videotaped interaction. Based on residential staff recommendations and review by 
residential staff involved in both Phase 1 and 2 and our field notes, we developed an orientation manual for 
residential staff. Orientation will be conducted before the start of the intervention in our proposed study, and we 
will guide residential staff during the program (see Appendices C and D). Also, we will space out the six content 
sessions over three months (1 every other week) to allow time to assimilate problem-solving skills, and have 
one booster session six weeks later (midway through the maintenance phase, at Week 18). In sum, our pilot 
work suggests that STEPS is likely to improve the SPS of individuals with ID and residential staff and likely to 
improve group-level SPS. Also, our pilot work shows that it is feasible to implement STEPS within the group 
home with high levels of satisfaction. 
B3b. Methods 
B3b1. Design. A cluster-randomized clinical trial design will be used in which 36 group homes (14 male, 14 female, 
and 8 co-ed) will be randomly assigned to either the STEPS intervention (n = 18; 7 male, 7 female, and 4 co-ed 
homes) or attention-control (n = 18; 7 male, 7 female, and 4 co-ed homes). We have worked with or are currently 
working with eight agencies, five of which were in the original nine that were randomly ordered for participation. 
Two more of the original nine requested to be contacted again in early 2019, related to absence of key staff for one 
and merger with another agency for the other.  Within some agencies, we will be able to identify six homes (2 of 
each gender and 2 co-ed) that meet criteria. Within agencies with only 3 homes for any or all three genders (male, 
female, co-ed) we will randomize homes within gender. If recruitment rates render a randomized home ineligible, 
we will randomly select an alternative home from a different agency. For agencies with only 1 eligible home for any 
gender, we will draw additional homes from a different agency. Whenever possible, we will adjust ordering of 
agencies to allow all participating homes within an agency to participate within the same time frame so that they are 
part of the same cohort. In addition, we may need to recruit additional agencies in order to reach the required 
number of 36 homes for this research . We will inform the IRB of any new agencies and provide letters of support. 
Group homes (residents and staff) will be recruited after randomization to simplify the process of explaining the 
study to individuals with ID. If fewer than two residential staff and/or fewer than three residents are willing to 
consent to participation, that group home will be ineligible and the third group home serving the same gender within 
that agency will be approached for recruitment. 
Group homes in both conditions will receive one session (STEPS or attention-control Food for Life) every other 
week for 12 weeks, for six total sessions, and a booster at 18 weeks. Data collection for both conditions will be at 
baseline (pre-intervention) and 12 weeks (post-intervention), to estimate intervention effects and at 24 and 36 
weeks after the start of the intervention to estimate maintenance. 
Prior to going on pause related to COVID 19 on March 12, 2020 We had already finished or begun the 
intervention at 25 homes  homes (8 female and 15 male, and 2 co-ed).  These include 17 homes with 24-week data 
collection, 5 with 12-week data collection, 4 that were part way through the intervention. There are an additional 2 
homes where we had all consents and completed baseline data collection, but had not started the intervention 
(both co-ed), and 7 homes where we had started the consent process (3 female, 4 co-ed).  Starting in study Week 
204 (Month 11 of Year 4), we will again recruit two  cohorts of five to six group homes (plan for two male, two  
female, and 1-2 co-ed home for each condition) , staggered to begin every 10-12 weeks over weeks 204-260. . 
There will be eight weeks of recruitment for each cohort of five- six  homes (allowing time to contact guardians if 
needed).  We plan to return to the homes where we had consents but had not completed the consent process or 
had not started the intervention and work to recruit these homes again. The COVID pandemic has led to efforts to 
improve online learning for this population http://project10.info/DPage.php?ID=428). Internet-based technology has 
been found to be feasible among persons with ID for more than 10 years (Lotan et al., 2009). We now will conduct 
the intervention virtually.Data will be collected using an intent-to-treat approach; thus, we will attempt to collect data 
from subjects even if they stop attending groups. 
Setting and subjects. Agencies have on average 25 group homes, each serving 4-8 individuals with ID. The 
setting for the study will be group homes for individuals with mild to moderate ID located in the Chicago area. 
Individuals with mild to moderate ID have an IQ of 50-75 and basic reading and writing skills ranging from being 
able to write their names and addresses to writing simple sentences; hold jobs in work centers, supported 
employment of independent community employment; may take public transportation independently; and need 
support in instrumental activities of daily living such as budgeting, making appointments, and nutrition planning. The 
group homes accept only residents aged 18 or over. Each group home has two or more residential staff working an 
afternoon/evening shift when residents eat the evening meal and engage in afternoon/evening activities. Most 
group homes were formerly single-family homes (not specifically built to be group homes) and look like other 
homes in the neighborhoods. Homes typically have a living room, dining room, kitchen, bedrooms, and often a 
recreation room. Homes have laundry facilities, a common TV in the living room, and recreational materials. 
Residential staff and residents cook meals. Staff and residents do the regular cleaning, and agencies have 

maintenance staff for heavier cleaning and repairs. Residents often have their own TVs in their bedrooms and 
usually share a bedroom with one roommate. Residential staff in Illinois are only required to have an 8th grade 
education, though most agencies require 12th grade.63 They receive assistance from QIDPs who are required to 
have a Bachelor’s degree in a human service field and at least one year of experience working with individuals with 
ID.51 
Group home inclusion/exclusion criteria are: (1) serve individuals with mild to moderate ID; (2) have at least 10 
A/CB incident reports in resident files over the prior six-month period, with at least 30% of residents in each home 
having incident reports in that period; (3) have 5 or more residents, with a minimum of 3 agreeing to participate; (4) 
individuals with ID and residential staff all speak English; and (5) have one residential staff member who agrees to 
participate. Group homes will be excluded if they serve individuals with ID who also have serious mental illness 
(e.g., severe autism, schizophrenia) or homes for forensic populations. Group homes that participated in the pilot 
study (B3a) will be excluded. Ten accredited agencies located across the Chicago area, managing over 225 group 
homes serving individuals with mild to moderate ID, have agreed to participate (see letters of support, Appendix A). 
. Generally, agencies do not have their homes located closer than 1.5 miles to one another (Figure 4); eight of ten 
are included on the map. This geographic separation reduces contamination across sites. 
Individuals with ID inclusion criteria are: (1) mild to moderate ID (operationalized as IQ 50-7564 per agency 
records) and mild to moderate limitations in adaptive functioning (measured by the Inventory for Client and Agency 
Planning65 used in all residential agencies in Illinois, per agency record); (2) live in a chosen group home; and (3) 
verbal and speak English. Individuals who participated in the pilot study (B3a) will be excluded. 
Residential staff inclusion criteria are: (1) employed as residential staff in the chosen group homes and (2) 
speak and read English. Residential staff who do not meet these criteria or who participated in the pilot study (B3a) 
will be excluded. 
Recruitment, consent, and retention. We will use the successful recruitment and retention strategies tested in 
pilot study B3a,21,22 modified to be virtual. Agencies will identify homes meeting the inclusion criteria. Though we do 
not anticipate unwillingness to participate, going forward we will randomize 6 group homes (2 male, 2 female, and 2 
co-ed) from each of 4 agencies (where we had not yet completed the intervention or with which we had not yet 
worked with) for randomization. . Randomization steps are: (1) randomly order agencies for participation (2) within 
each agency, six homes will be randomly assigned to the STEPS or attention-control condition (1 male, 1 female, 
and 1 co-ed home per condition). Once randomized, agency personnel will distribute a recruitment flyer and a form 
to residential staff asking their agreement to be contacted by a research team member. Once the recruitment flyer 
is returned (scanned document via email, fax, USPS), A research team member will contact the residential staff 
member via phone or Webex and determine best means to send the consent form to the residential staff. Materials 
can be sent via email, fax, or USPS. Once the staff person has the consent, the research team member will again 
contact the residential staff, explain the study, read the consent form over with the residential staff, confirm 
eligibility, answer questions, and obtain consent and set up a means to have consent sent to research team. 
Materials can be sent via email, fax, or USPS. . The flyer and consent explicitly state: (1) participation is voluntary; 
(2) the agency does not require or expect participation; and (3) there are no consequences to any conditions of 
employment or performance evaluations if they do not participate. Once the residential staff are recruited (at least 
two), recruitment of individuals with ID will commence. If the residential staff or the residents decline participation, 
the home will be replaced by the extra home from that agency. We will recruit until we have 11 additional homes ( 
[3 male, 4 female, and  
 co-ed] in each condition). As we have already recruited 25 homes that completed all or some of the intervention, 
we do not expect to have as many co-ed homes as male and female in the study. 
For individuals with ID who have a legal guardian, agencies will send the guardian a recruitment letter about the 
purpose of the study and eligibility. A research team member will call all legal guardians who express an interest to 
explain the study and answer questions. A consent form will be sent to the guardian. Guardian consent may be 
sent to us by mail, fax or email of scanned document. After guardian consent is obtained, a research team member 
will contact the potential participant by phone or Webex to explain the study, answer questions and explain that 
participation is voluntary.   They will also answer questions and obtain assent from the individuals with ID. For 
individuals with ID who are their own guardians, an agency QIDP will read a flyer about the study and obtain 
agreement to be contacted. Once the recruitment flyer is returned (scanned document via email, fax, USPS), a 
research team member will contact the individual with ID via phone or Webex and determine best means to send 
the consent form. Materials can be brought by an agency staff person, sent via email, fax, or USPS. Once the 
individual with ID has the consent, the research team member will again contact the individual, explain the study, 
read the consent form over with the person, confirm eligibility, answer questions, and obtain consent and set up a 
means to have consent sent to research team. If the individual with ID prefers, a residential staff person can be 

present for assistance. Participant consent may be sent to us by mail, fax or email of scanned document.. Based on 
previous experience, we will use Fisher and Cea's68 recommendations to assess ability of individuals with ID to 
consent/assent (Appendix B). Those unable to consent/assent will not be accepted.  
Participating individuals with ID and staff in STEPS and attention-control Food for Life conditions will receive $20 
for each data collection assessment: baseline, 12, and 24 weeks. The interventionist or research assistant will 
contact participants who miss sessions to invite them to continue if they still wish.(see Human Subjects). We will 
maintain regular (at least every two weeks) contact with agency management staff to discuss progress and any 
concerns. (see Environment). Also, we have access to the Community Engagement Board of the Center for Clinical 
and Translational Science at the University of Illinois at Chicago for input on recruitment and retention (see Letters 
of Support). 
STEPS Intervention. The STEPS intervention consists of a half-day residential staff orientation, which we will set 
up by phone or Webex at a convenient time; residential staff will be oriented to the STEPS intervention to improve 
SPS skills, and practice assignments will be explained. Following this, six sessions (every other week for 12 weeks) 
for residential staff and residents, plus one booster session (at week 18 during maintenance), will be led virtually by 
a research team interventionist. To match the qualifications of QIDPs, interventionists will have a bachelor's degree 
in a human services field such as sociology, special education, rehabilitation counseling, or psychology, and at 
least one year of experience with individuals with ID.51 
The six one-hour group sessions follow the standardized STEPS manual. Each session has  an interactive gameto 
build group cohesiveness. The games were developed during our pilot work (B3a). To standardize delivery, each 
session has  a script to present the material, with visual representations of emotions and actions. These  are used 
to prompt and reinforce discussion during the sessions. The presentations and associated worksheets for between 
sessions will be sent to   the home prior to the session for both individuals with ID and residential staff to view 
before and after the session as desired. Based on our previous work,69,70 we will provide highlights of the previous 
sessions that will be written by the project director in consultation with the interventionists using a standardized 
format developed during our pilot (See Appendices C and D). The highlights will be sent to the home before   the 
following session (via scanned document, fax to agency staff, or mail0 to help with engagement and provide cues 
for retention of materials. The highlights are only for the residents and residential staff in the group home. At the 
end of each session, participants the  worksheets to practice skills learned in the training will be explained. They 
will be asked to complete the worksheets they received  prior to  the next session. We will also have sent 
Residential staff additional materials with tips on how to help residents practice. Table 1 presents the STEPS 
sessions with the SPS concepts (attitude, define problem, identify alternatives, predict outcomes, and try out 
solutions) and corresponding content. 
 
1 
The W’s: Who 
We Are, What 
Makes Us 
Introduction 
to Attitude, 
Define, 
Introductions, describe program, introduce selves 
Content: Begin “Stop and slow down.” Pick a name for group. 
Practice worksheets: “What Is Special about Me” and “My Ways to Stop 
2 
Don’t 
Get 
Mad; 
Stop and 
Slow 
Attitude, Define 
Interactive group exercise 
Content: Think positive, Describe problems likely to lead to A/CBs. 
Describe immediate emotional responses (“triggers”) likely to lead to 
A/CBs. Practice “Stop and Slow Down.” 
Practice worksheets: “I Stop and Slow Down” and “Top 10 Ways to 
3 
W
e 
H
a
Attitude, Define 
Interactive group exercise. 
Content: See problems as challenges; describe/break down problems. 
Describe problems likely to lead to “acting out.” Describe problems 
likely to lead to avoidance 
4 
Things Happen 
Alternatives, Predict 
Interactive group exercise. 
Content: Alternative solutions; consequences when dealing with 
problem well or “acting out.” 
5 
Bright 
Alternative
Alternatives, Predict 
Interactive group exercise. 
Content: Practice “brainstorming” alternatives; predict what will 
6 
Sum
mary 
Try out 
Review Sessions 1–
Interactive problem-solving game 
Content: Trying out possible solutions to 
7 
Booster 
Session 
Review Sessions 1–
6 
Interactive problem-solving game with elements of 
Attitude, Define, Alternatives, Predict, and Try out 
 
 

B3b4. Attention-control: Food for Life nutrition program. This program is based on work by Dr. Heller (co-I) for 
an earlier NIH-funded program comparing a control to an exercise and nutrition program for both individuals with ID 
and their staff or family caregivers.69-72 Dr. Ailey was a research staff member on the project and responsible for 
delivering the program. A nutrition intervention was chosen for the attention-control because nutrition is an issue 
among individuals with ID.  A U.S. based population study found a combined rate of overweight and obesity among 
adults with ID to be 64%; thus, all participants will receive an intervention directed at needs. Previous research also 
indicated that carer training in health promotion and active support affects the nutritional intake of individuals with 
ID. Attention control Food for Life sessions will be led by an interventionist with the same qualifications as STEPS 
interventionists. They will follow the standardized Food for Life manual (Appendix D). As with the STEPS 
intervention, there will be six one-hour sessions every other week for 12 weeks and a booster in Week 18. As in 
STEPS, copies of the presentation for each session and associated worksheets for practice between session will 
be sent to the home prior to  the sessions, and highlights will be sent prior to the following sessions to help with 
engagement and provide cues for retention of materials. The sessions and content of each session are shown in 
Table 2. Drs. Ailey and Moro will oversee the integrity of the Food for Life attention-control intervention. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Questionnaires will be read to individuals with ID during virtual data collection visits. The Measures (Table 3) have 
been successfully used with individuals with ID. (See Table 3). 
 
Fidelity plan. Treatment fidelity will be assessed using the Behavior Change Consortium model, which assesses 
design, training, delivery, receipt, and enactment.80 Design: The intervention has been standardized with 
scheduled sessions and program manuals outlining all session activities and length. Training: Standardized 
training manuals have been developed for (1) interventionists and intervention research assistants; (2) data 
collectors; and (3) PST raters. Interventionists and intervention research assistants in both conditions will receive 
10 hours training in delivering their respective interventions from the PI and Project Coordinator Dr. Moro. After the 
first cohort of four STEPS and attention-control group homes receive the interventions, we will provide two more 
hours of training to reinforce procedures. We will meet separately every other week with STEPS interventionists 
and with attention-control interventionists and their respective research assistants to review experiences and 
problems of the past session and prepare for the next intervention session. Additional maintenance training will be 
delivered yearly. Intervention research assistants will participate virtually in the  STEPS or attention-control session, 
take notes during intervention to be used in highlights, assist with the intervention, andaudiotape the sessions using 
the record audio only function in Webex. As in our previous pilot study,29,57,81 to ensure high-quality data, social 
workers, nurses, and persons with experience interviewing individuals with ID or other vulnerable populations were 
trained as data collectors. They  received eight hours of training in the administration of questionnaires and 
videotaping procedures for the IFIRS. After completion of data collection for the first cohort of four group homes, we 
provided two more hours of training to reinforce procedures. Prior to the commencement of virtual data collection, 
they will receive training sessions on conducting virtual  data collection and will conduct mock virtual data collection 
on Webex using other data collectors and research assistants. All training and supervision of data collectors will be 
conducted separately from that of intervention staff.  
 
 
1 
The W’s: Who 
We Are, What 
Introductions, describe program, introduce 
selves. What foods do we like? Why is food 
2 
My Plate 
Content: What should the plate have on it? 
My foods that make the plate. 
3 
Water 
Content: What is good about water? 
Alternatives to soda. 
4 
Snacks 
Content: Better vending-
5 
Let’s Go 
Out to 
Content: What do we like when we go 
out to eat? Healthy choices. 
6 
Sum
Content: “Eat and be healthy”; 
7 
Booster 
Content: “We make healthy choices.” 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
] 
 
 
 
 
Sources: S = Self-Report; V = Videotape; A = Audiotape; R = Agency Records; W = Work Setting 
 
 
 
 
 
 
. 
 
We will use the same data collectors for intervention and attention-control. Every attempt will be made to conceal 
from data collectors the allocation of homes to intervention or attention-control condition.82 The PI and Project 
Coordinator Dr. Moro will train all interventionists, intervention research assistants, and data collectors on how to 
deal with adverse events and high depression scores .They will be trained on how to respond to suicidal intentions 
and how to defuse and/or manage A/CBs displayed during group sessions or data collection (See Appendix E). The 
protocols for suicidal ideation and A/CBs  were written by the PI Dr. Ailey and Dr. Paun, a psychiatric nurse 
specialist). PST raters will be trained by the PI and Project Coordinator Dr. Moro to score the audiotapes of the 
Problem-Solving Task (see Measures).42 We will keep and review notes of the training sessions and of research 
team meetings about training. Delivery: All sessions for STEPs and the Food for Life attention control will be 
digitally audiotaped. We modified Breitenstein’s Fidelity Checklist83 to assess adherence to the STEPS and 
attention-control interventions and competence in its delivery. We will randomly select 25% of session audiotapes 
to score with the Fidelity Checklist and will observe, via Webex, 10% of intervention sessions. This information will 
Table 3: Concepts/Measures, Reliability/Validity, Participant Burden, Source, and Data Collection Time Point for Behaviors 
Concept/Measure 
 
Reliability/Validity 
 
Range 
 
Mins 
 
Participant Sourcea 
Schedule 
(weeks) 
Individuals with ID (IWID) outcomes 
0 12 24 36 
SPS skills 
o IFIRS Individual-level Problem-solving scales (5 
items coded from videotaped interactions)62,73 
Predictive, 
convergent, and 
discriminant validity73 
 
5-45 
 
30 
 
IWID 
V 
X 
X 
 
X  
o Problem-solving Task (PST) (5 problems, 20 items, 
0-5 scale coded from audiotape)42 
Alpha .88-.93 
.83 interrater 
.79 test-retest 
0-100 
20-30 IWID 
A 
X 
X 
X  
A/CBs 
o IFIRS Dyadic-interaction scales (22 items coded 
from videotaped interactions)62,73 
 
Predictive, 
convergent, and 
discriminant validity73 
 
22-198 
 
N/A 
 
IWID 
V 
X 
X 
 
X  
o GMI scale of ICAP GMI) (8 domains, 0-5 frequency, 
0-4 severity)65 
.80 interrater 
.80 test-retest 
0-40 
0-32 
N/A 
IWID 
R, W 
X 
X 
X X 
o Behavior incident reports (collected weekly) 
N/A 
 
N/A 
IWID 
R 
X 
X 
X X 
A/CB behavioral determinants 
0 12 24 36 
• Demographics: Age, gender, ethnicity, level of ID 
N/A 
 
N/A 
IWID 
R, S 
X 
 
 
• Life events : Life events section of Psychiatric 
Assessment Schedule for Adults with Developmental 
Disabilities (17 items 2-recent 1-event 0-never) 
Convergent validity 
IWID74-77 
0-34 
15-20 IWID 
S 
X 
X 
X  
• Environment: Agency characteristics (urban/suburban, 
# of clients ,types of services, # of homes), Home 
characteristics (agency, location, gender, # of 
residents) 
N/A 
 
N/A 
 
R 
X 
 
 
• Current health 
o Depression -LD (20 items, 0-2 scale)78 
Alpha .87-.9028,78 
 
0-40 
 
15-20 
 
IWID 
S 
X 
X 
 
X  
o Medication management 
N/A 
N/A 
IWID 
R 
X 
X 
X 
Nutrition  
  o Adapted Nutrition and Activity Knowledge Scale for    
Adults with ID 
Weight and BMI 
 
 
 
 
S 
 
 
R 
X 
 
 
X 
X 
 
 
X 
X 
 
 
X 
 
Support environment for SPS 
0 12 24 36 
• Residential staff SPS 
o SPSI-R SF (25 items, 0-5 scales)61,79 
Alpha .88-.9361,79 
 
0-125 
 
15-20 
 
Res staff 
S 
X 
X  
 
o IFIRS Individual-level Problem-solving scales (5 
items coded from videotaped interactions)62,73 
Predictive, 
convergent, and 
discriminant validity73 
5-45 
N/A 
Res staff 
V 
X 
X 
X  
• Group SPS 
o IFIRS Group-level Problem-solving scales (4 items 
coded from videotaped interactions)62,73 
Predictive, 
convergent, and 
discriminant validity73 
 
4-36 
 
N/A 
 
Group 
 
 
V 
X 
X 
 
X  
• Group cohesiveness 
o Group Intervention Environment Scale (Sessions 1 
and 6)50 
Alpha .8750 
 
8-32 
 
N/A 
 
Group 
A 
X 
X  
 
Support for Nutrition 
 
 
 
 
 
 
o Residential staff nutrition knowledge 
o  
 
7-28 
9-36 
5-10 
5-10 
Res staff 
Res staff 
S 
S 
X 
X 
X 
X 
x 
x 
x 
 
 

be used to update training of staff and prevent drift. Receipt of the seven sessions, or dose, will be Procedures. 
Baseline data collection: The time needed for administration of questionnaires and videotape (baseline, 12 weeks, 
and 24 weeks) is estimated at 1 hour 40 minutes for individuals with ID, and 25-40 minutes for the residential staff. 
Based on our pilot study, the attention of individuals with ID can be held for approximately 50 minutes. Therefore, 
data collection for individuals with ID will be broken into two sessions. Also, participants will be given breaks as 
desired. During the first data collection session, For the data collection, research team members will work with 
residential staff to find a private, quiet place in the homes and to get assistance from staff if needed. All of the 
measures will be administered via Webex. Responses to the GDS will be recorded in REDCap. For the PST, the 
data collector will read the vignette to the resident being interviewed and record the response using the audio only 
function in Webex. Data collection for residential staff members will be conducted at their convenience over the 
phone or virtually. Answers will be entered into REDCap. 12- and 24-week data collection: will use the same 
procedures as at baseline data collection the questionnaires and audiotapes of the Problem-solving Task (PST)42 
will be completed. Self-report questionnaires will be read to each individual with ID and will be done over Webex 
with the participant in a private, quiet place in the homes. For the PST, the data collector will read the vignette to 
the resident being interviewed and audiotape the response using the audio only record function in Webex.. A 
second data collection visit will be arranged to obtain the digital recording of the entire group that will be used to 
score the IFIRS.62,73 For the IFIRS, the data collector will meet with the group over Webex and help the group 
generate the topic for discussion. The group of individuals with ID and their staff will discuss the problem. The 
discussion with be recorded with the webcam video function in Webex. Data collection for residential staff members 
will be conducted at their convenience via phone or Webex. The Webex recorded videos will be made available for 
secure download by Dr. Melby’s laboratory at Iowa State University (Ames, IA) to be scored by her specialists. 
Intervention: Intervention sessions for STEPS and attention-control sessions will be conducted via Webex. The 
group of individuals with ID and their residential staff will be asked to use   a dining room or kitchen table as a place 
to talk and look at materials.  Based on our pilot study (B3a), sessions will be held from approximately 6:30–7:45 
p.m. on a weeknight. The evening before the session, the interventionist will reconfirm the time. All sessions are 
audiotaped using the audio only record function in Webex for fidelity. Audiotapes from Sessions 1 and 6 will be 
used to score the IGES.  Interventionists and research assistants will meet every other week with the PI and 
intervention coordinator over Webex 
12- and 24-week data collection: The procedures will be the same as baseline. The GMI will be obtained from 
QIDPs at the agency. 
Data collectors: 
 
Videographer: 
 
Interventionists:  Daniel Reitsma, Kelly Flinkman,  Sally Scheib, Deanna Ellis and Ella Swanson are contracted staff 
for the interventions. NIH Human Subjects training certificates are available for these staff. See documents below.  
 
We are adding Virshauna Brown, Samantha Kreps; Camila Sanchez; Nicole Karabas; and Micala GIammarino as 
Research Assistants.  
 
We are adding We are adding Horace Nowell III, Jaime Chang, Maura Benson, Margaret Czerwein as research 
assistants. All have Citi training. 
 
We are adding Taylor White (English) as a Research Assistant. She is a Rush employee and has Citi training. 
 
We are adding Rianna Bachan as a Research Assistant. She is a Rush nursing student who is work study. She has 
completed Citi training and compliance training. She will be doing data entry. 
A/CB determinants. Demographics (age, gender, ethnicity, and level of ID) will be obtained from agency records. 
Life events are measured by staff- report with the Life Events section of the Psychiatric Assessment Schedule for 
Adults with Developmental Disabilities 75.It is used extensively in this population. It is predictive of emergency room 
visits for A/CBs, psychopathology, and psychiatric events.75-77 Environment includes whether homes are 
urban/suburban and the number of people living in the homes. Current health includes depressive symptoms of 

individuals with ID and medication management. The Glasgow Depression Scale for People with Learning 
Disabilities [GDS-LD]78)was developed for use among individuals with ID (called "learning disabilities" in the UK). It 
has sensitivity ranging 90-96% and specificity ranging 83.9–90%, with a score of 13.39,78
 
Information on 
psychotropic medications will be gathered from agency records. 
Support environment for social problem solving. These include the residential staff SPS, group SPS, 
and group cohesiveness. The residential staff SPS will be measured in two ways. The IFIRS Individual-level 
Problem-solving Scales62,73
 
are the same instrument used with individuals with ID. Also, a self-report measure, 
Social Problem Solving Inventory Revised – Short Form (SPSI-R SF), will be used.61,79The five dimensions of 
this measure are positive attitude, negative attitude, rational style, impulsive/careless style, and avoidant style. 
Group SPS will be will be measured with IFIRS Group-level Problem-solving Scales.62,73
 
The scales include 
problem-solving enjoyment, agreement on problem description/solution, implementation, and problem difficulty 
for group, and are scored by Dr. Melby’s staff. Group cohesiveness will be measured using the Intervention 
Group Environment Scale (IGES).50The IGES is a 25-item measure of group environments. The three subscales 
are implementation and preparedness, counterproductive activity, and cohesiveness.50
 
In previous research, it 
related to health behavior outcomes.50
 
The IGES will be scored using audiotapes from Sessions 1 and 6 by 
trained research assistants. In our pilot study, graduate nursing students were trained to do the rating of the 
IGES.22 
Individuals with ID Outcomes: Nutrition. Nutrition outcomes are measured in three ways, nutrition 
knowledge, weight and BMI. We will measure nutrition knowledge using the Adapted Nutrition and Knowledge 
Scale for Adults with Intellectual Disabilities76,77 We will address the mediating effect of residential staff nutrition 
knowledge of residential staff on the nutrition knowledge, weight and BMI of participants with ID. 
B3b6. Fidelity plan. Treatment fidelity will be assessed using the Behavior Change Consortium model, 
which assesses design, training, delivery, receipt, and enactment.
80 
Design: The intervention has been 
standardized with scheduled sessions and program manuals outlining all session activities and length. 
Training: Standardized training manuals have been developed for (1) interventionists and intervention research 
assistants; (2) data collectors; and (3) PST raters. Interventionists and intervention research assistants in both 
conditions received 10 hours training in delivering their respective interventions from the PI Dr. Ailey and 
Research Coordinator Dr.Moro. After the first cohort of four STEPS and attention-control group homes received 
the interventions, we  provided two more hours of training to reinforce procedures. We will meet separately every 
other week with STEPS interventionists and with attention-control interventionists and their respective research 
assistants to review experiences and problems of the past session and prepare for the next intervention session. 
Additional maintenance training will be delivered yearly. Intervention research assistants will be trained to , take 
notes during intervention to be used in highlights, and audiotape the sessions. Prior to the commencement of 
virtual interventions, interventionists and research assistants will receive training sessions on conducting virtual 
interventions and will conduct mock virtual interventions on Webex using other interventionists and research 
assistants. As in our previous pilot study,29,57,81
 
to ensure high-quality data, social workers or nurses with 
experience interviewing individuals with ID were  trained as data collectors. They received eight hours of training 
in the administration of questionnaires and videotaping procedures for the IFIRS. After completion of data 
collection for the first cohort of four group homes, we provided two more hours of    training to reinforce 
procedures. All training and supervision of data collectors will be conducted separately from that of intervention 
staff. We will use the same data collectors for intervention and attention-control. Every attempt will be made to 
conceal from data collectors the allocation of homes to intervention or attention-control condition.82
 
The PI and 
Co-I Dr. Paun, a psychiatric nurse specialist, will train all interventionists, intervention research assistants, and 
data collectors on how to deal with adverse events and high depression scores. They were or will be trained (if 
new) on how to respond to suicidal intentions and how to defuse and/or manage A/CBs displayed during group 
sessions or data collection (See Appendix E). Prior to the commencement of virtual data collection, they will 
receive training sessions on techniques and challenges in virtual  data collection and will conduct mock virtual 
data collection on Webex using other data collectors and research assistants. PST raters will be trained by the 
PI Dr. Ailey and Research Coordinator Dr. Moro to score the audiotapes of the Problem-Solving Task (see 
Measures).42
 
We will keep and review notes of the training sessions and of research team meetings about 
training. Delivery: All sessions for STEPs and the attention control will be digitally audiotaped using the audio 
only recording function in Webex.. We modified Breitenstein’s Fidelity Checklist83
 
to assess adherence to the 
STEPS and attention-control interventions and competence in its delivery. We will randomly select 25% of 
session audiotapes for research assistants under the directions of Drs. Ailey and Moro to score with the Fidelity 
Checklist and will observe in person 10% of intervention sessions. This information will be used to update 
training of staff and prevent drift. Receipt of the seven sessions, or dose, will be assessed by tracking 
attendance. We will use a web-based tracking system, Study360,84
 
to monitor and calculate attendance rates. 
Attendance rates for individuals with ID and residential staff will be calculated as the number of sessions 
attended divided by total number of sessions. Reasons for not attending, if known, will be collected throughout 
the intervention from individuals with ID and residential staff, and a log will be kept. Using a checklist we 
developed in our pilot study, we will randomly select 25% of audiotaped sessions to determine the number of 
times each individual participated in discussion of a covered skill and whether the individual gave an example of 

how he/she used or would use the skill. With these data, we can assess receipt of the intervention by 
participants. Satisfaction of the individuals with ID and residential staff will be measured at 12 weeks. 
Enactment will be assessed by counting the number of completed and returned practice worksheets (total = 8 
per individual with ID). 
B3b7. Procedures. Baseline data collection: The time needed for administration of questionnaires and 
videotape (baseline, 12 weeks, and 24 weeks) is estimated at 1 hour 50 minutes for individuals with ID, and 50 
minutes for the residential staff. Based on our pilot study, the attention of individuals with ID can be held for 
approximately 50 minutes to one hour. Therefore, data collection for individuals with ID will be broken into two 
sessions. Also, participants will be given breaks as desired. During the first data collection session, the 
questionnaires and audiotapes of the Problem-solving Task (PST)
42 
will be completed. For the data collection, 
research team members will work with residential staff to find a private, quiet place in the homes and to get 
assistance from staff if needed. All of the measures will be administered via Webex. Responses to the GDS will 
be recorded in REDCap. For the PST, the data collector will read the vignette to the resident being interviewed 
and record the response using the audio only function in Webex. 12- and 24-week data collection: will use the 
same procedures as at baseline data collection A second data collection visit will be arranged to obtain the 
digital videotape of the entire group that will be used to score the IFIRS.
62,73 
For the IFIRS, the data collector will 
help the group generate the topic for discussion. Data collection for residential staff members will be conducted 
at their convenience over the phone or virtually. Answers will be entered into REDCap.  . The videos will be 
made available for secure download by Dr. Melby’s laboratory at Iowa State University (Ames, IA) to be scored 
by her specialists. 
Intervention: Intervention sessions for STEPS and attention-control sessions will be held virtually. The 
interventionist and research assistant will conduct the session.  They will ask the participants in the group  to 
use a dining room or kitchen table as a place to talk and look at materials.  Based on our pilot study (B3a), 
sessions will be held from approximately 6:30–7:45 p.m. on a weeknight. The evening before the session, the 
interventionist will reconfirm the time. All sessions are audiotaped for fidelity using the audio only record 
function in Webex.. Audiotapes from Sessions 1 and 6 will be used to score the IGES. Interventionists will bring 
audiotapes to the project office. Interventionists and research assistants will meet every other week with the PI 
and intervention coordinator. 
12- and 24-week data collection:. The procedures will be the same as baseline. Participants (individuals 
with ID and residential staff) will be given a 
$20 gift card after each data collection. 
B3b8. Data analysis. All tracking of participants will follow CONSORT85
 
and be entered into the RedCap 
database. SPSS for Windows (v. 23) and SAS (v. 9.3) will be used for data management and statistical 
analysis. Descriptive statistics for all variables will be obtained; t tests and chi-square analyses will be 
performed on demographics, baseline life events, environment, and current health (depression symptoms and 
medication management) to determine if intervention and control groups are comparable. Missing data will be 
imputed using SAS software and the multiple imputation strategy described by Rubin.86
 
To reduce Type-I error 
associated with multiple dependent variables, a .01 significance level will be used for all tests. From previous 
research, we expect all outcome measures to be close to normally distributed. We will use Tukey’s87
 
ladder of 
transformation to achieve normality, if needed. Outcome measures that cannot be successfully transformed to 
achieve normality will be analyzed separately using the rank-ordered multilevel analysis available in SAS. 
Specific Aim 1. Because multiple dependent variables are being examined, a repeated-measures 
multivariate analysis of variance will be conducted to ensure control of experiment-wise a, and to perform an 
initial assessment of intervention effects. We will then calculate intervention efficacy on individual measures of 
SPS skills and A/CBs of individuals with ID using a nested hierarchical model; the three levels will be group 
home, person within site, and time-point within person. All analyses will be performed on an intent-to-treat basis. 
Intervention condition will be dummy coded (treatment vs. control) at the level of the group home. To control for 
effects of background characteristics on the intervention, measures associated with background variables will be 
entered into the model as two propensity measures: one based on individual measures, the other based on 
group home measures. This is, in effect, a two-level propensity analysis. This two-level approach is a novel and 
innovative statistical method for conducting propensity analysis. Propensity analysis is a well-validated statistical 
approach useful in balancing groups on observed covariates so that analyses of treatment effects are more 
accurate.88,89
 
If a propensity measure has a nonsignificant effect, it will be discarded; if significant, it will be 
included in the final model. Categorical covariates (e.g., gender, ethnicity) will be dummy-coded and entered into 
the model as a block. Propensity scores will be estimated using individual participant (e.g., age, length of 
residence) and group home level measures (e.g. location [urban/suburban], gender, and number of 
residents/home) that could influence outcomes. We also will check for differences in baseline SPS and A/CBs by 
agency and by interventionist; if found, we will enter these into the propensity score analysis. This final set of 
variables (the direct predictors) will constitute an optimal model for assessing each outcome measure. 
Specific Aim 2. We expect the support environment for SPS (residential staff SPS, group SPS, and group 
cohesiveness) to mediate improvements that occur in the individuals with ID. To assess the mediating effects, we 

will modify the regression models discussed in MacKinnon (p. 49).
90 
MacKinnon’s models generate three 
regression equations and then examine the impact of a single mediator in terms of reduced variance explained in 
the outcome from the direct predictor variable when the mediator variable is included in the model. The same 
approach will be used in this analysis, except that we will examine multilevel regression instead of simple 
regression models.
91,92 
With this modified approach, we will estimate three sets of regression equations for each 
of the three potential mediators making up the support environment for SPS, crossed with each of the measures 
of SPS skills and A/CBs of individuals with ID. Intervention condition will be included as predictor variables in 
these mediation models. The first set of regression equations estimates the simple effect of the intervention on 
the SPS skills and A/CBs of the individuals with ID (Aim 1). The second set estimates the effect of the 
intervention on the mediator variables (residential SPS, group SPS, or group cohesiveness). The third set 
estimates the combined effects of the intervention and mediators on the group measures of SPS skills and A/CBs 
of the individuals with ID. We will examine the impact of the change in the estimated coefficients associated with 
the introduction of each mediator. Significant mediators will be left out of subsequent models because of 
concerns about collinearity. Retention of a significant mediator may make it difficult to detect mediation effects in 
subsequent analyses. Though several mediation models are being estimated in this aim, the analysis is based on 
the assumption that significance values are of limited use in analysis to find mediation effects.
90 
Our analyses 
should allow us to evaluate whether the support environment for SPS mediates the relation between the 
intervention and the outcomes and should give us information on which mediation variables are responsible for 
the effect.
 
Identifying key mediators will contribute to enhancing the intervention, improving long-term cost-
effectiveness, and designing future interventions. The same type of analysis will be conducted to determine the 
effects of the Food for Life nutrition intervention and the mediating effects of residential staff nutrition knowledge 
of the nutrition knowledge, weight and BMI of participants with ID. 
Specific Aim 3. Evaluate the cost-effectiveness of STEPS relative to usual care. 
Methods. We will evaluate the cost-effectiveness of STEPS from the societal perspective, taking into 
account costs borne by the program, group home, health care system, public services, participant, and family. 
STEPS will be compared to usual care (control group costs of A/CBs excluding costs of the nutrition 
intervention). We will conduct additional analyses separately from the perspective of the program, group home, 
health care system, public services, and participant. For cost measurement, quantities of resources used and 
their associated prices will be collected for the program (either prices paid or value of staff time), group home 
(value of staff time) and participant (value of participant’s time to participate in STEPS). For the effectiveness 
measurement, effectiveness will be measured using the number of A/CB incidents. We will also quantify the cost 
of each A/CB incident to calculate the net cost (or savings) of STEPS relative to standard of care. A/CB costs 
include for group home, participant and family members, public service (value of police officer time, ambulance), 
and health care system (cost per ED visit, urgent care or other physician visit, hospitalization) costs. To calculate 
total program-related costs, the program, group home, and participant costs will be summed to calculate total 
cost per participant. Similarly, total A/CB costs will be summed across the group home, participant and family, 
public service and health care system. All costs will be valued in 2016 dollars. 
Data for the cost-effectiveness analysis will be drawn from study records, incident reports, and group home 
staff time logs (Table 4). Cost-effectiveness will be evaluated by combining the mean total program-related cost 
per participant with the number of A/CBs. We will calculate the incremental cost-effectiveness ratio (ICER) 
for STEPS relative to usual care, such that !"#$ = ("
1 − "
0
)⁄(#
1 − #
0
), where C is program cost and E is 
effectiveness. Subscript 1 denotes STEPS and subscript 0 denotes usual care. 95% confidence intervals for 
the ICERs will be calculated to evaluate the uncertainty of these results.
93-95 
We will conduct one-way and multi-
way sensitivity analyses for the key parameters to evaluate whether the ICERs are sensitive to plausible 
changes in their values. The sensitivity analysis is a check on the robustness and will determine the key 
parameters impacting the ICERs. We will also plot acceptability curves based on varying threshold (willingness 
to pay) values for a one-incident reduction in the number of A/CBs. Also, because A/CB incident costs will be 
collected, we will calculate the net cost (or net savings) associated with STEPS, such that the net cost = 
program-related cost – A/CB incident cost. 
Specific Aim 4:  Evaluate the effect of the Food for Life intervention and the mediating effect of the nutrition 
knowledge of residential staff on nutrition knowledge, weight and BMI of participants with ID. We hypothesize that 
participants in the attention control Food for Life nutrition intervention will show greater improvement in nutrition 
knowledge and improvement in weight and BMI for overweight and obese individuals compared to the STEPS 
intervention.  
B3b9. Potential problems and alternative strategies: (1) We have no assessment-only control, which 
may attenuate our findings. However, we are assessing the mediation effects of the support environment for 
SPS in our analysis. (2) The attention-control group may also be affected by being in a group intervention. We 
therefore minimized group process in our attention-control group. (3) The assessment process may affect the 
SPS skills of residents and residential staff and the A/CBs of residents. To minimize this possibility, no 
feedback will be given on responses to questionnaires about problem-solving or the problem-solving discussion 
used to code the IFIRS, and no practice of problem-solving is provided in the assessment process. 

(4) Incident reports are filled out by residential staff who observe the incidents and reviewed by QIDPs. Bias in 
reporting by residential staff based on intervention condition is possible. The agencies, however, have protocols 
for reporting incidents, and, during orientation to the program, we will instruct residential staff to continue to use 
those protocols. Bias, if present, is more likely to impact reports of minor incidents (e.g., arguments) than reports 
of serious incidents (e.g., involving injury or property damage). By analyzing serious incidents separately, we will 
minimize bias in incident reports. We also have a second measure of behavior not dependent on residential staff 
report, the IFIRS Dyadic Interaction Scales. Finally, we are collecting data on A/CBs from work setting 
supervisors where informants will be naïve to study conditions. Though it is possible that IFIRS coders or work 
setting supervisors may become aware of study condition, this is expected to be rare and to have minimal impact 
on study results. (5) We have chosen to randomize prior to recruitment so that individuals with ID can be told 
specifics about the intervention to which they have been assigned. Although it would be ideal to randomize after 
recruitment and baseline data collection, trying to explain to individuals with ID that they may be assigned to 
either STEPS or a nutrition intervention would likely be confusing. (6). While we only have 3 measures related to 
nutrition among individuals with ID and one measure among residential staff, our study has a larger sample size 
participating in a nutrition intervention than previous studies, has a homogenous sample and defined 
randomization techniques. We expect to contribute to the body of research on nutrition interventions in this 
population. 
*Interventionist time to 
Study payroll reports 
Minutes per 
Average hourly wage 
*Residential staff 
Attendance records 
Minutes per 
Average hourly wage 
*Participant time to 
Attendance records 
Minutes per session 
Minimum wage 
Residential staff time to 
Staff 
Minutes per staff 
Average hourly wage 
Residential staff 
Staff 
Minutes per staff 
Average hourly wage 
QIDP time to review incident 
Staff 
Minutes per 
Average hourly wage 
Residential staff and QIDP 
Staff 
Minutes per 
Average hourly wage 
Repair/replacement costs 
Staff self-
Actual cost 
Actual cost 
Participant time related to the 
Incident report 
Minutes per incident 
Minimum wage 
Family member(s) time related 
Incident report 
Minutes per incident 
Average hourly wage 
Police officer time to intervene 
Incident report 
Minutes per police 
Average hourly wage 
ED visits 
Incident report 
Occurrence of visit 
National average cost for an ED 
visit with principal diagnosis of a 
behavioral health condition or 
Hospitalizations 
Incident report 
Occurrence of 
hospital stay and 
length of hospital 
National average cost for a 
hospital stay with a principal 
diagnosis of a behavioral health 
Urgent care and other 
physician visits 
Incident report 
Occurrence of visit 
National average cost for an ED 
visit with principal diagnosis of a 
behavioral health condition or 
 
 
 
 
 

 
 
B3b10. Timeline. In the first three months of funding, we will hire staff, complete preparations for data collection 
and intervention, and work with partner agencies to finalize the identification and selection of eligible group 
homes. We will begin recruitment of participants in the first group homes in Month 4 and complete recruitment 
by Month 32. All group homes should have completed the intervention sessions (1-6) by Month 35 and 12-week 
data collection by Month 36. Booster sessions will be completed by Month 37 and 24-week data collection by 
Month 38. All incident reports will be collected by Month 40. We anticipate this timeline to be reasonable based 
on recruitment and data collection experience in our preliminary study.