Autism Spectrum DisorderNCT04869540
Improving Transition Outcomes for Youth With ASD in a Medicaid Accountable Care Organization
A study testing 'Got Transition' toolkit and resources and PSE intervention in people with Autism Spectrum Disorder, run by Boston Medical Center.
Trial summary
Despite an increasing number of children with Autism Spectrum Disorder (ASD), fragmentation across child and adult service systems results in poor education, employment and health outcomes for transition-aged youth (TAY). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- 'Got Transition' toolkit and resources and PSE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Dec 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Speak English or Spanish
Who cannot join
- Foster families
- Families in which a parent has either serious mental illness or limited cognitive capacity
About this study
Official title: Improving Transition Outcomes for Youth With Autism Spectrum Disorder From Within a Medicaid Accountable Care Organization
Despite an increasing number of children with Autism Spectrum Disorder (ASD), fragmentation across child and adult service systems results in poor education, employment and health outcomes for transition-aged youth (TAY). The investigators will develop a transition intervention embedded in a series of systems-level strategies currently being deployed in a large Medicaid Accountable Care Organization (ACO). The investigators will conduct a randomized pilot study of 40 families of TAY with ASD. All families will receive care by providers trained in the Got Transition toolkit (the systems level component of the intervention) and have access to web-based transition resources. Families in the 'intervention refinement' arm will also receive a family-based problem solving education (PSE) intervention.
Read the detailed description
This is a randomized pilot study of 40 families of TAY with ASD. Families will be randomly allocated to study arms - not for the purpose of maximizing internal validity; but rather, to allow us to refine recruitment techniques that maximize the acceptability of randomization. Twenty families in the 'intervention refinement' arm will receive a PSE-based intervention; among this group, the model will be refined in real time - based on both experience delivering the intervention and ongoing qualitative data collection. Refinement arm participants will receive a PSE prototype based on prior initial adaptations.
Each pilot family will also be asked to participate in a semi-structured interview. The interviews will be conducted after families have experienced at least 3 PSE sessions and use their data to further refine the model and develop hypotheses concerning testable intervention targets.
Among 20 families in a control-like 'parameter estimation' arm, empiric estimates will be obtained of study parameters key to the design of a future trial. All families in this arm will receive care from providers trained in the Got Transition toolkit, and will have access to web-based resources for creating a young adult vision statement and for accessing multiple service sectors. Participants will be tracked over six-months. Consistent with pilot methods, the analysis will not emphasize comparisons across study arms
- Conditions
- Autism Spectrum Disorder
- Being tested
- Usual care, 'Got Transition' toolkit and resources, PSE intervention
- Keywords
- Transition-aged youth (TAY), Medicaid ACO, Got Transition toolkit, Problem solving education (PSE)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
Evidence based care for transition-aged youth (TAY) with ASD.
'Got Transition' toolkit and resourcesOther
Providers will be trained in the 'Got Transition' toolkit (the systems level component of the intervention) and have access to web-based transition resources.
PSE interventionBehavioural
A family-based problem solving education (PSE) intervention.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Families randomized to this arm will receive the usual care by providers trained in the 'Got Transition' toolkit and that have access to web-based transition resources. Receives: Other: Usual care; Other: 'Got Transition' toolkit and resources |
| Usual care + PSE | Experimental | Families randomized to this arm will receive the usual care by providers trained in the 'Got Transition' toolkit and that have access to web-based transition resources and will also receive a family-based problem solving eduction (PSE) intervention. Receives: Other: Usual care; Other: 'Got Transition' toolkit and resources; Behavioral: PSE intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) ASD
The PEDI-CAT ASD is a parent report measure that assesses abilities in three functional domains: Daily Activities, Mobility, and Social/Cognitive. A separate Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex life tasks that enable independent living in the areas of Organization \& Planning, Taking Care of Daily Needs, Health Management, and Staying Safe. The PEDI-CAT is valid up to age 21 and is specific to youth with ASD. Normative standard scores (provided as age percentiles and T scores) and Scaled Scores are available for 59 age groups. Typically, T-scores between 30 and 70 (i.e. mean ± 2 standard deviations) are considered within the expected range for age.
Measured: Baseline
6 months PEDI-CAT ASD
The PEDI-CAT ASD is a parent report measure that assesses abilities in three functional domains: Daily Activities, Mobility, and Social/Cognitive. A separate Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex life tasks that enable independent living in the areas of Organization \& Planning, Taking Care of Daily Needs, Health Management, and Staying Safe. The PEDI-CAT is valid up to age 21 and is specific to youth with ASD. Normative standard scores (provided as age percentiles and T scores) and Scaled Scores are available for 59 age groups. Typically, T-scores between 30 and 70 (i.e. mean ± 2 standard deviations) are considered within the expected range for age.
Measured: 6 months
Secondary outcomes (13)
Social skills
The 65 item Social Responsiveness Scale-2 assesses social impairment associated with ASD. Results are reported as T-scores for 5 treatment subscales: Social Awareness- 8 items to measure the ability to recognize social cues of others; Social Cognition- 12 items that addresses interpretation of social behavior; Social Communication- 22 items to assess reciprocal communication in social situations; Social Motivation- 11 items that assesses an individual's motivation to participate in social interactions; Restricted Interests \& Repetitive Behavior- a 12 items that measures stereotypes and circumscribed interests; and the total score. T-scores of >76 are severe suggesting clinically significant deficits in social functioning that interfere with interactions with others. Scores 66-75 are moderate, signaling some clinically significant social deficits. T-scores of 60-65 indicate mild to moderate deficiencies in social behavior. T-scores < 60 indicate few social difficulties.
Measured: baseline
Cognition
The Wechsler Abbreviated Scale of Intelligence (WASI) is a validated, time-efficient which will be used to measure of cognition/cognitive ability. The average score is fixed at 100, with approximately two-thirds of all scores falling somewhere between 85 and 115. HIgher scores are correlated with higher cognition.
Measured: baseline
Parent Functioning and Depressive Symptoms assessed by SAS-SR
The Social Adjustment Scale Self-Report (SAS-SR) examines functioning in six areas, including role as parent. Raw scores are converted to gender-based standard scores (including T-scores and percentiles), with higher scores indicating higher levels of impairment (i.e., lower levels of social adjustment).
Measured: baseline
Parent Functioning and Depressive Symptoms assessed by QIDS
The 16 item Quick Inventory of Depressive Symptoms (QIDS) is valid and reliable measure of depressive symptoms. Total QIDS scores range from 0 to 27 with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression.
Measured: baseline
Family Empowerment
The Family Empowerment Scale is a validated 34-item instrument developed to measure empowerment in families with children who have emotional, behavioral, or mental disorders. Responses are from 1=not at all to 5= Very true with a range of scores form 34 to 170. Higher scores are correlated with more family empowerment.
Measured: baseline
Perceived parental stress
The 10 item perceived stress scale (PSS) will be used to assess parental stress. It includes domains in unpredictability, lack of control, burden overload, and stressful circumstances. 10 scores are obtained by reversing the scores on the four positive items. Scores around 13 are considered average. HIgher scores are correlated with more stress.
Measured: baseline
Parental stress
The 13 item Autism Parenting Stress Index (APSI) will be used to assess how much stress parents are experiencing and what factors are causing this stress. The Items fall into three categories: the core social disability, difficult-to-manage behaviour, and physical issues. Items are rated as being 'Not stressful', 'Sometimes creates stress', 'Often creates stress', 'Very stressful on a daily basis', to 'So stressful that sometimes we feel we cannot cope.' Scores can rage form 0 to 65 and higher scores are correlated with more stress.
Measured: baseline
Perceived youth stress
The 10 item perceived stress scale (PSS) will be used to assess youth stress. It includes domains in unpredictability, lack of control, burden overload, and stressful circumstances. 10 scores are obtained by reversing the scores on the four positive items. Scores around 13 are considered average. HIgher scores are correlated with more stress.
Measured: baseline
Parental coping strategies
The 26 item Coping Self-Efficacy Scale will be used to measure the parent's ability to cope with life challenges in three domains: problem-focused coping, unpleasant thoughts, and getting support from others. Respondents are asked asked to rate on an 11-point scale the extent to which they believe they could perform behaviors important to adaptive coping. Anchor points on the scale are 0 ('cannot do at all'), 5 ('moderately certain can do') and 10 ('certain can do'). Higher scores are correlated with better coping strategies.
Measured: baseline
Youth coping strategies
The 26 item Coping Self-Efficacy Scale will be used to measure the youth's ability to cope with life challenges in three domains: problem-focused coping, unpleasant thoughts, and getting support from others. Respondents are asked asked to rate on an 11-point scale the extent to which they believe they could perform behaviors important to adaptive coping. Anchor points on the scale are 0 ('cannot do at all'), 5 ('moderately certain can do') and 10 ('certain can do'). Higher scores are correlated with better coping strategies.
Measured: baseline
Vocational and Educational Activities
The Vocational Index is a valid index of vocational and educational outcomes for youth and young adults with ASD. It has 11 categories coded on a 9-point scale, ranging from competitive employment and/or postsecondary educational program to no vocational/educational activities. HIgher scores are correlated with greater vocational and educational activities.
Measured: 6 months
Health Care Transition Readiness and Family Perception of Health Care Integration using TRAQ
The Transition Readiness Assessment Questionnaire (TRAQ) is a 20-item, 5-factor structure validated scale that assesses youths' ability to make appointments, understand medications and develop other transition skill. Answers are reported on a 1 to 5 scale based on the Stages of Change Model ranging from "I do not need to do this" to "I always do this when I need to." HIgher scores are correlated with greater transition readiness.
Measured: 6 months
Health Care Transition Readiness and Family Perception of Health Care Integration using the Pediatric Integrated Care Survey (PICS)
PICS is a 48 item survey designed to assess families' experience of health care integration. A composite score is derived based on the response and higher scores are correlated with greater transition readiness and health care integration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study startApr 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: The Investigator left the institution and the study was not implemented.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Michael Silverstein, MD MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869540
- Sponsor's protocol ID
- H-41693
- Other IDs
- 5K18MH120457
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Transition Outcomes for Youth With Autism Spectrum Disorder From Within a Medicaid Accountable Care Organization
- ClinicalTrials.gov ID
- NCT04869540
- Acronym / sponsor ID
- H-41693
- Conditions
- Autism Spectrum Disorder
- Keywords
- Transition-aged youth (TAY), Medicaid ACO, Got Transition toolkit, Problem solving education (PSE)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Investigator left the institution and the study was not implemented.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 May 2021 (actual)
- 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.
Despite an increasing number of children with Autism Spectrum Disorder (ASD), fragmentation across child and adult service systems results in poor education, employment and health outcomes for transition-aged youth (TAY). The investigators will develop a transition intervention embedded in a series of systems-level strategies currently being deployed in a large Medicaid Accountable Care Organization (ACO). The investigators will conduct a randomized pilot study of 40 families of TAY with ASD. All families will receive care by providers trained in the Got Transition toolkit (the systems level component of the intervention) and have access to web-based transition resources. Families in the 'intervention refinement' arm will also receive a family-based problem solving education (PSE) intervention.
Detailed description
This is a randomized pilot study of 40 families of TAY with ASD. Families will be randomly allocated to study arms - not for the purpose of maximizing internal validity; but rather, to allow us to refine recruitment techniques that maximize the acceptability of randomization. Twenty families in the 'intervention refinement' arm will receive a PSE-based intervention; among this group, the model will be refined in real time - based on both experience delivering the intervention and ongoing qualitative data collection. Refinement arm participants will receive a PSE prototype based on prior initial adaptations.
Each pilot family will also be asked to participate in a semi-structured interview. The interviews will be conducted after families have experienced at least 3 PSE sessions and use their data to further refine the model and develop hypotheses concerning testable intervention targets.
Among 20 families in a control-like 'parameter estimation' arm, empiric estimates will be obtained of study parameters key to the design of a future trial. All families in this arm will receive care from providers trained in the Got Transition toolkit, and will have access to web-based resources for creating a young adult vision statement and for accessing multiple service sectors. Participants will be tracked over six-months. Consistent with pilot methods, the analysis will not emphasize comparisons across study arms
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual care, Other: 'Got Transition' toolkit and resourcesFamilies randomized to this arm will receive the usual care by providers trained in the 'Got Transition' toolkit and that have access to web-based transition resources. |
| Usual care + PSE | Experimental | Other: Usual care, Other: 'Got Transition' toolkit and resources, Behavioral: PSE interventionFamilies randomized to this arm will receive the usual care by providers trained in the 'Got Transition' toolkit and that have access to web-based transition resources and will also receive a family-based problem solving eduction (PSE) intervention. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Speak English or Spanish
Key exclusion criteria (2 listed)
- Foster families
- Families in which a parent has either serious mental illness or limited cognitive capacity
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 |
|---|---|---|
| Usual careEvidence based care for transition-aged youth (TAY) with ASD. | Other | Usual care, Usual care + PSE |
| 'Got Transition' toolkit and resourcesProviders will be trained in the 'Got Transition' toolkit (the systems level component of the intervention) and have access to web-based transition resources. | Other | Usual care, Usual care + PSE |
| PSE interventionA family-based problem solving education (PSE) intervention. | Behavioural | Usual care + PSE |
Primary outcome
Baseline Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) ASD
Time frame: Baseline
The PEDI-CAT ASD is a parent report measure that assesses abilities in three functional domains: Daily Activities, Mobility, and Social/Cognitive. A separate Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex life tasks that enable independent living in the areas of Organization \& Planning, Taking Care of Daily Needs, Health Management, and Staying Safe. The PEDI-CAT is valid up to age 21 and is specific to youth with ASD. Normative standard scores (provided as age percentiles and T scores) and Scaled Scores are available for 59 age groups. Typically, T-scores between 30 and 70 (i.e. mean ± 2 standard deviations) are considered within the expected range for age.
6 months PEDI-CAT ASD
Time frame: 6 months
The PEDI-CAT ASD is a parent report measure that assesses abilities in three functional domains: Daily Activities, Mobility, and Social/Cognitive. A separate Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex life tasks that enable independent living in the areas of Organization \& Planning, Taking Care of Daily Needs, Health Management, and Staying Safe. The PEDI-CAT is valid up to age 21 and is specific to youth with ASD. Normative standard scores (provided as age percentiles and T scores) and Scaled Scores are available for 59 age groups. Typically, T-scores between 30 and 70 (i.e. mean ± 2 standard deviations) are considered within the expected range for age.
13 secondary outcomes
Social skills
Time frame: baseline
Cognition
Time frame: baseline
Parent Functioning and Depressive Symptoms assessed by SAS-SR
Time frame: baseline
Parent Functioning and Depressive Symptoms assessed by QIDS
Time frame: baseline
Family Empowerment
Time frame: baseline
Perceived parental stress
Time frame: baseline
Parental stress
Time frame: baseline
Perceived youth stress
Time frame: baseline
Parental coping strategies
Time frame: baseline
Youth coping strategies
Time frame: baseline
Vocational and Educational Activities
Time frame: 6 months
Health Care Transition Readiness and Family Perception of Health Care Integration using TRAQ
Time frame: 6 months
Health Care Transition Readiness and Family Perception of Health Care Integration using the Pediatric Integrated Care Survey (PICS)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Michael Silverstein, MD MPH principal investigator
Boston Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing 'Got Transition' toolkit and resources and PSE intervention in people with Autism Spectrum Disorder, run by Boston Medical Center.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Baseline Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) ASD (time frame: Baseline). The study lists 2 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 22 Apr 2022.