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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transdiagnostic Sleep and Circadian Intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate (feasibility) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristina P Lenker, PhD | Contact | 7175310003 | 280299 | klenker2@pennstatehealth.psu.edu |
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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).
Data will be available beginning 9 months after publication of the primary trial results manuscript and ending 5 years following that publication date.
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.
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012890 | Sleep |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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 | 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 | 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 | 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 | 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) |