Problem BehaviorSTEPSNCT02855008
Steps to Effective Problem Solving in Group Homes
A study testing STEPS and Food for Life in people with Problem Behavior, run by Rush University Medical Center at 1 site in United States.
Trial summary
Aggressive/challenging behaviors in individuals with intellectual disability are a major public health concern for them, their families, their service programs and staff, and their communities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Problem Behavior
- What is being tested?
- STEPS and Food for Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2016to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group home
- Serve individuals with mild to moderate ID;
- 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
- Have 4 or more residents, with a minimum of 3 agreeing to participate
- Individuals with ID and residential staff all speak English
- Have at least one residential staff members who agree to participate.
Show all 11Show fewer
- Has mild to moderate ID (operationalized as IQ 50-75 per agency records) and mild to moderate limitations in adaptive functioning (measured by the Inventory for Client and Agency Planning used in all residential agencies in Illinois, per agency record)
- Lives in a chosen group home
- Is verbal and speaks English
- Employed as residential staff in the chosen group homes and
- Speak and read English
Who cannot join
- If group home specifically serves individuals with ID who also have serious mental illness (e.g., severe autism, schizophrenia)
- If group home specifically serves forensic populations
- If the group home participated in previous preliminary study
- Individual with ID
- If individual does not meet inclusion criteria and
- If participated in the preliminary study
Show all 9Show fewer
- Residential staff
- Does not meet inclusion criteria
- Participated in the previous preliminary study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Steps to Effective Problem Solving in Group Homes for Individuals With Intellectual Disabilities
Aggressive/challenging behaviors in individuals with intellectual disability are a major public health concern for them, their families, their service programs and staff, and their communities. This randomized clinical trial will test the efficacy and cost effectiveness of a preventive community-based social problem solving intervention, the Steps to Effective Problem-solving (STEPS), delivered in group homes. The program uses residential staff participation and the group environment to facilitate improved social problem solving skills and reduce aggressive/challenging behaviors in this population in group homes and work settings.
Read the detailed description
Aggressive/challenging behaviors (AC/Bs) are a major public health problem for individuals with intellectual disabilities (ID) living in group homes. A leading reason for psychiatric hospitalizations and incarcerations, A/CBs are costly to the healthcare system, agencies and families. Social problem solving (SPS) training programs for individuals with ID have had positive behavioral results, but most were conducted in clinical or forensic settings. None were community-based preventive interventions, none examined whether A/CBs decreased in participants' group homes and work settings, and none addressed cost effectiveness. In preliminary work, the investigators modified an effective SPS training program, using input from individuals with ID and residential staff, as a preventive intervention for the group home setting. Steps to Effective Problem-solving (STEPS) includes residential staff and uses the group home environment to facilitate behavior change. The purpose of this clinical trial is to test the efficacy of STEPS for individuals with ID. Specific aims are to 1) Assess the efficacy of the STEPS intervention in group homes to improve SPS skills and reduce A/CBs of the individuals with ID compared to an attention-control nutrition program from baseline to 12, 24 and 36 weeks, controlling for behavioral determinants of A/CBs (demographics, agency/home environment, current health). 2) Assess the mediating effect of the support environment for SPS (residential staff SPS skills, group home level SPS skills, and group cohesiveness) on the improvement of SPS skills and reductions in A/CBs. 3) Evaluate cost effectiveness of STEPS relative to usual care for A/CB incidents in group homes. The investigators expect to show STEPS to be a preventive behavioral strategy to reduce A/CBs among individuals with ID, improve the cost effectiveness of their care and make an important incremental advance in SPS research.
- Conditions
- Problem Behavior
- Being tested
- STEPS, Food for Life
- Keywords
- Social Problem-Solving, Intellectual Disability, Problem Behaviors, Community based intervention, Prevention
- Medical subject headings
- Problem Behavior, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPSBehavioural
Agencies providing residential services to individuals with ID gave us letters of agreement (N=9) when we submitted for funding. We randomized these agencies and followed the specific order. Over the past year, recruitment issues have resulted in our only being able to recruit at six of the original nine agencies. To address the issues, we compiled a list of 15 additional local agencies within a 50 mile radius. We are recruiting from an additional six agencies and are in contact with another four. We also changed our recruitment criteria to include co-ed homes. Within each agency we then, (1) determine homes that that meet criteria and, by gender (male, female, co-ed), randomize to STEPS or attention-control condition. Residential staff are consented first. Individuals with ID (or guardians if they have one) are then consented. 18 homes will participate in STEPS.
Food for LifeBehavioural
Agencies providing residential services to individuals with ID gave us letters of agreement (N=9) when we submitted for funding. We randomized these agencies and followed the specific order. Over the past year, recruitment issues have resulted in our only being able to recruit at six of the original nine agencies. To address the issues, we compiled a list of 15 additional local agencies within a 50 mile radius We are recruiting from an additional six agencies and are in contact with another four. We also changed our recruitment criteria to include co-ed homes. Within each agency we then, (1) determine homes that that meet criteria and, by gender (male, female, co-ed), randomize to STEPS or attention-control condition. Individuals with ID and staff are recruited after randomization. Residential staff are consented first. Individuals with ID (or guardians if they have one) are then consented. 18 homes will participate in Food for Life.
| Study group | Role | What they receive |
|---|---|---|
| STEPS | Experimental | Experimental: Individuals with ID and residential staff in group homes receive 6 one-hour STEPS sessions over 12 weeks and a booster in week 18 following a standardized manual. Sessions include interactive games to build group cohesiveness, along with interactive discussion and practice. Participants are given session materials and 1-2 worksheets to practice learned skills and are asked to return the worksheets at the next session. Residential staff are given additional materials with tips on how to help residents practice social problem-solving skills between sessions. Highlights of each session using a standardized format are brought to the following session to help with engagement and provide cues for retention of materials. Receives: Behavioral: STEPS |
| Food for Life | Active comparator | Active Comparator: Individuals with ID and residential staff in group homes receive 6 one-hour Food for Life sessions over 12 weeks and a booster in week 18 following a standardized manual. Sessions include interactive games regarding food and nutrition followed, along with interactive discussion and practice. Participants are given session materials and 1-2 worksheets to practice learned skills and are asked to return the worksheets at the next session. Residential staff are given additional materials with tips on how to help residents practice Food for Life skills between sessions. Highlights of each session using a standardized format are brought to the following session to help with engagement and provide cues for retention of materials. Receives: Behavioral: Food for Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales
Change from baseline Individual with ID SPS: Uses a 15-20 minute videotape of a problem-solving interaction of the group of individuals with ID living in the group home and their residential staff to assess individuals with ID SPS skills - solution quantity, solution quality, effective process, disruptive process, and negotiation/compromise at the individual level.
Measured: Baseline, 12, and 24 weeks
Problem-solving Task (PST)
Change from baseline Individual with ID SPS: Has four questions on each of five problem vignettes that measure individual with ID SPS skills. The vignettes are read by data collectors to the individuals and responses audiotaped.
Measured: Baseline, 12, and 24 weeks
The IFIRS Dyadic-interaction scales
Change from baseline Individual with ID Behaviors: Uses the same 15-20 minute videotape of a problem-solving interaction to assess individual with ID A/CBs. Items include hostility, verbal attack, physical attack, contempt, etc. (total 22 items) of each individual with ID
Measured: Baseline, 12 and 24 weeks
General Maladaptive Index
Change from baseline Individual with ID Behaviors: Qualified Intellectual Disability Professionals (QIDPs) at the residential agency and work setting supervisors (sheltered workshops and employment) will be asked to fill out the GMI on participants with ID. The GMI measures the frequency (0 = never to 5 = one or more times an hour) and severity (0 = not serious to 4 = extremely serious) of problem behaviors in eight domains (hurtful to self or others, destructive, disruptive, socially offensive, unusual/repetitive, withdrawn/inattentive, uncooperative).
Measured: Baseline, 12 and 24 weeks
Agency incident reports
Change from baseline Individual with ID behaviors: Residential staff members fill out incident reports. The reports are reviewed by QIDPs, kept in resident files, and tracked by the agencies. Data will be abstracted from agency tracking records and de-identified. The investigators will analyze counts of incidents for outcomes and summarize descriptive data of key elements of the incident reports.
Measured: For 24 weeks prior to intervention, 12, 24 and 36 weeks
Secondary outcomes (4)
The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales
Change from baseline Residential staff SPS (Support environment for Individual with ID). Uses the same 15-20 minute videotape of a problem-solving interaction of the group of individuals with ID living in the group home and their residential staff to assess residential staff SPS skills - solution quantity, solution quality, effective process, disruptive process, and negotiation/compromise at the individual level.
Measured: Baseline,12 and 24 weeks
Social Problem Solving Inventory Revised - Short form (SPSI-R SF)
Change from baseline Residential staff SPS (Support environment for Individual with ID). The five dimensions of this measure are positive attitude, negative attitude, rational style, impulsive/careless style, and avoidant style.
Measured: Baseline, 12 and 24 weeks
IFIRS Group Problem-solving Scales
Change from baseline of Group (of individuals with ID and their residential staff) SPS (Support environment for Individual with ID). The scales include problem-solving enjoyment, agreement on problem description/solution, implementation, and problem difficulty for group,
Measured: Baseline,12 and 24 weeks
Group Environment for the Intervention Scale (GEIS)
Change from baseline of group environment - cohesiveness (Support environment of individual with ID). The GEIS is a 25-item measure of group environments. The three subscales are implementation and preparedness, counter-productive activity, and cohesiveness. The GEIS will be scored using audiotapes from Sessions 1 and 6 by trained research assistants.
Measured: Week 1 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start7 Sep 2016
- Primary completion31 May 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sarah Ailey, Rush University Medical Center
- Investigators
- Sarah H Ailey, PhD RN, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855008
- Sponsor's protocol ID
- R01HD086211
- Other IDs
- 1R01HD086211-01A1
- Acronym
- STEPS
- Status last verified
- Nov 2022
- First submitted
- 1 Aug 2016
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The investigators will share aggregated data
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steps to Effective Problem Solving in Group Homes for Individuals With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT02855008
- Acronym / sponsor ID
- STEPS / R01HD086211
- Conditions
- Problem Behavior
- Keywords
- Social Problem-Solving, Intellectual Disability, Problem Behaviors, Community based intervention, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Sep 2016 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aggressive/challenging behaviors in individuals with intellectual disability are a major public health concern for them, their families, their service programs and staff, and their communities. This randomized clinical trial will test the efficacy and cost effectiveness of a preventive community-based social problem solving intervention, the Steps to Effective Problem-solving (STEPS), delivered in group homes. The program uses residential staff participation and the group environment to facilitate improved social problem solving skills and reduce aggressive/challenging behaviors in this population in group homes and work settings.
Detailed description
Aggressive/challenging behaviors (AC/Bs) are a major public health problem for individuals with intellectual disabilities (ID) living in group homes. A leading reason for psychiatric hospitalizations and incarcerations, A/CBs are costly to the healthcare system, agencies and families. Social problem solving (SPS) training programs for individuals with ID have had positive behavioral results, but most were conducted in clinical or forensic settings. None were community-based preventive interventions, none examined whether A/CBs decreased in participants' group homes and work settings, and none addressed cost effectiveness. In preliminary work, the investigators modified an effective SPS training program, using input from individuals with ID and residential staff, as a preventive intervention for the group home setting. Steps to Effective Problem-solving (STEPS) includes residential staff and uses the group home environment to facilitate behavior change. The purpose of this clinical trial is to test the efficacy of STEPS for individuals with ID. Specific aims are to 1) Assess the efficacy of the STEPS intervention in group homes to improve SPS skills and reduce A/CBs of the individuals with ID compared to an attention-control nutrition program from baseline to 12, 24 and 36 weeks, controlling for behavioral determinants of A/CBs (demographics, agency/home environment, current health). 2) Assess the mediating effect of the support environment for SPS (residential staff SPS skills, group home level SPS skills, and group cohesiveness) on the improvement of SPS skills and reductions in A/CBs. 3) Evaluate cost effectiveness of STEPS relative to usual care for A/CB incidents in group homes. The investigators expect to show STEPS to be a preventive behavioral strategy to reduce A/CBs among individuals with ID, improve the cost effectiveness of their care and make an important incremental advance in SPS research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEPS | Experimental | Behavioral: STEPSExperimental: Individuals with ID and residential staff in group homes receive 6 one-hour STEPS sessions over 12 weeks and a booster in week 18 following a standardized manual. Sessions include interactive games to build group cohesiveness, along with interactive discussion and practice. Participants are given session materials and 1-2 worksheets to practice learned skills and are asked to return the worksheets at the next session. Residential staff are given additional materials with tips on how to help residents practice social problem-solving skills between sessions. Highlights of each session using a standardized format are brought to the following session to help with engagement and provide cues for retention of materials. |
| Food for Life | Active comparator | Behavioral: Food for LifeActive Comparator: Individuals with ID and residential staff in group homes receive 6 one-hour Food for Life sessions over 12 weeks and a booster in week 18 following a standardized manual. Sessions include interactive games regarding food and nutrition followed, along with interactive discussion and practice. Participants are given session materials and 1-2 worksheets to practice learned skills and are asked to return the worksheets at the next session. Residential staff are given additional materials with tips on how to help residents practice Food for Life skills between sessions. Highlights of each session using a standardized format are brought to the following session to help with engagement and provide cues for retention of materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Group home
- Serve individuals with mild to moderate ID;
- 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
- Have 4 or more residents, with a minimum of 3 agreeing to participate
- Individuals with ID and residential staff all speak English
Key exclusion criteria (9 listed)
- If group home specifically serves individuals with ID who also have serious mental illness (e.g., severe autism, schizophrenia)
- If group home specifically serves forensic populations
- If the group home participated in previous preliminary study
- Individual with ID
- If individual does not meet inclusion criteria and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEPSAgencies providing residential services to individuals with ID gave us letters of agreement (N=9) when we submitted for funding. We randomized these agencies and followed the specific order. Over the past year, recruitment issues have resulted in our only being able to recruit at six of the original nine agencies. To address the issues, we compiled a list of 15 additional local agencies within a 50 mile radius. We are recruiting from an additional six agencies and are in contact with another four. We also changed our recruitment criteria to include co-ed homes. Within each agency we then, (1) determine homes that that meet criteria and, by gender (male, female, co-ed), randomize to STEPS or attention-control condition. Residential staff are consented first. Individuals with ID (or guardians if they have one) are then consented. 18 homes will participate in STEPS. | Behavioural | STEPS |
| Food for LifeAgencies providing residential services to individuals with ID gave us letters of agreement (N=9) when we submitted for funding. We randomized these agencies and followed the specific order. Over the past year, recruitment issues have resulted in our only being able to recruit at six of the original nine agencies. To address the issues, we compiled a list of 15 additional local agencies within a 50 mile radius We are recruiting from an additional six agencies and are in contact with another four. We also changed our recruitment criteria to include co-ed homes. Within each agency we then, (1) determine homes that that meet criteria and, by gender (male, female, co-ed), randomize to STEPS or attention-control condition. Individuals with ID and staff are recruited after randomization. Residential staff are consented first. Individuals with ID (or guardians if they have one) are then consented. 18 homes will participate in Food for Life. | Behavioural | Food for Life |
Primary outcome
The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales
Time frame: Baseline, 12, and 24 weeks
Change from baseline Individual with ID SPS: Uses a 15-20 minute videotape of a problem-solving interaction of the group of individuals with ID living in the group home and their residential staff to assess individuals with ID SPS skills - solution quantity, solution quality, effective process, disruptive process, and negotiation/compromise at the individual level.
Problem-solving Task (PST)
Time frame: Baseline, 12, and 24 weeks
Change from baseline Individual with ID SPS: Has four questions on each of five problem vignettes that measure individual with ID SPS skills. The vignettes are read by data collectors to the individuals and responses audiotaped.
The IFIRS Dyadic-interaction scales
Time frame: Baseline, 12 and 24 weeks
Change from baseline Individual with ID Behaviors: Uses the same 15-20 minute videotape of a problem-solving interaction to assess individual with ID A/CBs. Items include hostility, verbal attack, physical attack, contempt, etc. (total 22 items) of each individual with ID
General Maladaptive Index
Time frame: Baseline, 12 and 24 weeks
Change from baseline Individual with ID Behaviors: Qualified Intellectual Disability Professionals (QIDPs) at the residential agency and work setting supervisors (sheltered workshops and employment) will be asked to fill out the GMI on participants with ID. The GMI measures the frequency (0 = never to 5 = one or more times an hour) and severity (0 = not serious to 4 = extremely serious) of problem behaviors in eight domains (hurtful to self or others, destructive, disruptive, socially offensive, unusual/repetitive, withdrawn/inattentive, uncooperative).
Agency incident reports
Time frame: For 24 weeks prior to intervention, 12, 24 and 36 weeks
Change from baseline Individual with ID behaviors: Residential staff members fill out incident reports. The reports are reviewed by QIDPs, kept in resident files, and tracked by the agencies. Data will be abstracted from agency tracking records and de-identified. The investigators will analyze counts of incidents for outcomes and summarize descriptive data of key elements of the incident reports.
4 secondary outcomes
The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales
Time frame: Baseline,12 and 24 weeks
Social Problem Solving Inventory Revised - Short form (SPSI-R SF)
Time frame: Baseline, 12 and 24 weeks
IFIRS Group Problem-solving Scales
Time frame: Baseline,12 and 24 weeks
Group Environment for the Intervention Scale (GEIS)
Time frame: Week 1 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: Yes. The investigators will share aggregated data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah H Ailey, PhD RN principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEPS and Food for Life in people with Problem Behavior, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Iowa Family Interactions Rating Scales (IFIRS) Individual-level Problem-solving scales (time frame: Baseline, 12, and 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.