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Not yet recruiting NCT07612111

Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents

No phase Interventional Sleep Autism Spectrum Disorder Transdiagnostic

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: 13 years — 17 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 →

Unsure about the terms? Read our patient guide →

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 adolescents, 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 adolescents, 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 adolescents diagnosed with Autism Spectrum Disorder (ASD).
  • Between the ages of 13 and 17 years.
  • English-speaking
  • Sufficient verbal communication skills to participate in interviews, surveys, or tasks.
  • Ability to provide informed assent with guardian consent.
  • 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 Intelligent Quotient (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: NCT07612111 · 27612

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗