Transdiagnostic Sleep and Circadian Treatment for Autistic Adults

March 9, 2026 updated by: Kristina Lenker, Milton S. Hershey Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Autistic adults diagnosed with ASD.
  2. Between the ages of 18 and 65 years.
  3. English-speaking
  4. 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:

  1. A history of IQ < 70.
  2. A history of psychotic, bipolar or seizure disorders as per medical record.
  3. Untreated sleep apnea, a history of narcolepsy, or restless legs syndrome, as per structured interview based on risk screeners.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transdiagnostic Sleep and Circadian Intervention
Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline (pretreatment)
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.
posttreatment (up to 6 weeks post baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
up to 6 months
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.
from enrollment to session 6 (up to 6 months)
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.
posttreament (up to 3 months from baseline)
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.
from first session to posttreament (up to 3 months from baseline)
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.
from first session to posttreament (up to 3 months from baseline)
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.
from first session to posttreament (up to 3 months from baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 28767

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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