Transdiagnostic Sleep and Circadian Treatment for Autistic Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transdiagnostic Intervention for Sleep and Circadian Dysfunction.
- Who it may be relevant to
- Registry conditions: Sleep, Autism Spectrum Disorder, Transdiagnostic. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 ad
Primary outcome measures
- Multidimensional sleep health (MSH) score [Time frame: baseline (pretreatment)]
- Multidimensional sleep health (MSH) score [Time frame: posttreatment (up to 6 weeks post baseline)]
Secondary outcome measures (6)
- Enrollment rate (feasibility) [Time frame: up to 6 months]
- Participants retention rate (feasibility) [Time frame: 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)]
- Therapy Homework Completion Rate [Time frame: 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)]
- Treatment Fidelity: Therapist Strategy Use [Time frame: from first session to posttreament (up to 3 months from baseline)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07461844 · 28767