Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06537128
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
11 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • LUNA-Adolescent — BEHAVIORAL
    Learning to Understand and Navigate Anxiety-Adolescent (LUNA-Adolescent) includes parent-led, internet-based cognitive behavioral therapy (CBT) for anxiety among autistic youth.
  • Treatment as Usual — BEHAVIORAL
    Treatment as Usual includes 12 weekly sessions of transdiagnostic cognitive behavioral therapy (CBT) for anxiety in autistic youth.

Study Details

Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.

Key Dates

Start date
Nov 1, 2024
Status verified
Jul 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
139 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: LUNA-Adolescent
    Dyads in the Learning to Understand and Navigate Anxiety-Adolescent (LUNA-Adolescent) group will receive internet-based cognitive behavioral therapy (LUNA-Adolescent), which includes 12 weekly treatment modules, 6 bi-weekly, 30-minutes telehealth visits, and email check-ins.
  • Placebo Comparator: Treatment as Usual
    Dyads in the standard-care cognitive behavioral therapy (CBT) group will receive 12 weekly sessions of transdiagnostic CBT for anxiety in autistic youth.

Primary Outcome Measure

Pediatric Anxiety Rating Scale modified for ASD (PARS-ASD) [ Time Frame: Baseline (before treatment), during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Eric Storch, Ph.D.
[email protected]
713-798-3080

Find similar trials in Houston, TX

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Baylor College of Medicine· Houston, TX

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