Transdiagnostic Sleep and Circadian Treatment for Autistic Adults
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
Sleep and circadian problems are associated with deleterious social, emotional, and cognitive outcomes, yet are modifiable. This prospective study will adapt and optimize an empirically supported behavioral intervention that addresses common sleep and circadian problems of autistic adults, who are at increased risk for mental health disorders, using a transdiagnostic approach. The knowledge gained from this study will help to address a critical need for accessible transdiagnostic sleep interventions for autistic adults, who experience a broad range of sleep and circadian problems at high rates and often lack access to specialty care treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
Study Completion
Last participant's last visit for all outcomes
September 1, 2027
March 10, 2026
March 1, 2026
1 year
March 4, 2026
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Multidimensional sleep health (MSH) score
Multidimensional Sleep Health (MSH) score, a composite index summarizing six sleep dimensions: regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is classified as optimal (1) or suboptimal (0) using prespecified cutoffs: Regularity: standard deviation of sleep midpoint and total sleep time from actigraphy less than 60 minutes; Satisfaction: average self-reported ratings of sleep satisfaction (from the Insomnia Severity Index) and 'rested upon awakening' from sleep diary in the 'moderately' to 'extremely' satisfied/rested range; Alertness: Epworth Sleepiness Scale total score less than or equal to 9; Timing: average sleep midpoint from actigraphy between 02:00 and 04:00; Efficiency: average sleep efficiency from actigraphy at least 85%; Duration: average total sleep time from actigraphy between 7 and 9 hours. Dimension scores are summed to yield a total MSH score from 0 to 6, with higher scores indicating better overall sleep health.
baseline (pretreatment)
Multidimensional sleep health (MSH) score
Multidimensional Sleep Health (MSH) score, a composite index summarizing six sleep dimensions: regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is classified as optimal (1) or suboptimal (0) using prespecified cutoffs: Regularity: standard deviation of sleep midpoint and total sleep time from actigraphy less than 60 minutes; Satisfaction: average self-reported ratings of sleep satisfaction (from the Insomnia Severity Index) and 'rested upon awakening' from sleep diary in the 'moderately' to 'extremely' satisfied/rested range; Alertness: Epworth Sleepiness Scale total score less than or equal to 9; Timing: average sleep midpoint from actigraphy between 02:00 and 04:00; Efficiency: average sleep efficiency from actigraphy at least 85%; Duration: average total sleep time from actigraphy between 7 and 9 hours. Dimension scores are summed to yield a total MSH score from 0 to 6, with higher scores indicating better overall sleep health.
posttreatment (up to 6 weeks post baseline)
Secondary Outcomes (6)
Enrollment rate (feasibility)
up to 6 months
Participants retention rate (feasibility)
from enrollment to session 6 (up to 6 months)
Therapist Evaluation Questionnaire (TEQ) Total Score at End of Treatment
posttreament (up to 3 months from baseline)
Therapy Homework Completion Rate
from first session to posttreament (up to 3 months from baseline)
Treatment Session Completion Rate
from first session to posttreament (up to 3 months from baseline)
- +1 more secondary outcomes
Study Arms (1)
Transdiagnostic Sleep and Circadian Intervention
EXPERIMENTALInterventions
Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). This evidence-based intervention targets psychosocial, behavioral, and cognitive processes that maintain sleep and circadian problems. The 4 Core Modules are: establishing regular sleep-wake times and routines; improving daytime functioning; correcting unhelpful sleep-related beliefs; and maintenance of behavior change. The optional Modules are: improving sleep efficiency; reducing time in bed; dealing with delayed or advanced phase; reducing sleep-related worry/vigilance; and negotiating sleep in a complicated environment and reducing nightmares. TranS-C consists of a total of 6, 50-min sessions over six weeks.
Eligibility Criteria
You may qualify if:
- Autistic adults diagnosed with ASD.
- Between the ages of 18 and 65 years.
- English-speaking
- One or more sleep or circadian problem(s) for a period of at least 3 months assessed with the Sleep and Circadian Problems Interview.
You may not qualify if:
- A history of IQ \< 70.
- A history of psychotic, bipolar or seizure disorders as per medical record.
- Untreated sleep apnea, a history of narcolepsy, or restless legs syndrome, as per structured interview based on risk screeners.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychiatry and Behavioral Health
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 10, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available beginning 9 months after publication of the primary trial results manuscript and ending 5 years following that publication date.
- Access Criteria
- Researchers may request access for meta-analyses, secondary analyses, or replication studies that align with the trial's original aims. Requests must include a statistical analysis plan and be approved by the principal investigator and study biostatistician to ensure participant privacy and scientific merit.
De-identified individual participant data (IPD) collected for primary and secondary outcome measures-including Multidimensional Sleep Health (MSH) scores, Insomnia Severity Index (ISI) scores, Epworth Sleepiness Scale (ESS) scores, actigraphy-derived sleep parameters (duration, efficiency, timing, regularity), therapy engagement metrics (e.g., session attendance rate, homework completion rate), treatment fidelity data (TranS-C checklist adherence), and feasibility indicators (enrollment rate, retention rate)-will be made available. Accompanying materials will include the study protocol, statistical analysis plan, informed consent form (redacted), and codebooks defining all variables and scoring algorithms (e.g., MSH composite derivation).