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NCT Number: NCT07461844

Transdiagnostic Sleep and Circadian Treatment for Autistic Adults

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.

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Key information

Conditions

Sleep Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Transdiagnostic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Transdiagnostic Intervention for Sleep and Circadian Dysfunction

Behavioral

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.

Other names: TranS-C

Primary outcomes

  1. Multidimensional sleep health (MSH) score

    Time frame: baseline (pretreatment)

    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.

  2. Multidimensional sleep health (MSH) score

    Time frame: posttreatment (up to 6 weeks post baseline)

    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.

Secondary outcomes

  1. Enrollment rate (feasibility)

    Time frame: up to 6 months

    Number of participants enrolled per month over the planned recruitment period; calculated as total number enrolled divided by number of recruitment months.

  2. Participants retention rate (feasibility)

    Time frame: from enrollment to session 6 (up to 6 months)

    Percentage of enrolled participants who complete the final session (6 sessions). Calculated as the number who complete the final visit divided by the number enrolled, multiplied by 100.

  3. Therapist Evaluation Questionnaire (TEQ) Total Score at End of Treatment

    Time frame: posttreament (up to 3 months from baseline)

    Scores on Therapy Evaluation Questionnaire (TEQ). TEQ is a 7-item self-report scale rated 1-7, with higher scores indicating greater treatment credibility, willingness to participate, and perceived therapist warmth/competence; total score is the sum (range 7-49) or mean of all items, with higher scores reflecting more positive evaluation of therapy and therapist.

  4. Therapy Homework Completion Rate

    Time frame: from first session to posttreament (up to 3 months from baseline)

    Percentage of between-session therapy homework assignments completed by each retained participant. For each participant, the number of homework assignments reported as completed is divided by the number of homework assignments assigned during the treatment period, multiplied by 100 to yield a percentage. Higher percentages indicate greater adherence to assigned homework.

  5. Treatment Session Completion Rate

    Time frame: from first session to posttreament (up to 3 months from baseline)

    Percentage of retained participants who complete all scheduled treatment sessions. The number of retained participants who attend (or complete) every scheduled treatment session during the treatment period is divided by the total number of retained participants, multiplied by 100 to yield a percentage. Higher percentages indicate greater engagement with the treatment.

  6. Treatment Fidelity: Therapist Strategy Use

    Time frame: from first session to posttreament (up to 3 months from baseline)

    Percentage of prescribed TranS-C treatment strategies recorded as used on the therapist-reported fidelity checklist. For each session, therapists indicate which TranS-C strategies were delivered using a standardized checklist; the number of strategies marked as used is divided by the total number of strategies listed on the checklist, multiplied by 100 to yield a session-level fidelity percentage. Higher percentages indicate greater adherence to the TranS-C treatment protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina P Lenker, PhD

CONTACT

[email protected]

7175310003 ext. 280299

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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