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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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
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

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 groups in NCT04869540
Study groupRoleWhat they receive
Usual careActive comparatorFamilies 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 + PSEExperimentalFamilies 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted3 May 2021
  2. Study startApr 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Why it stopped: The Investigator left the institution and the study was not implemented.

Resources

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)
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

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.

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