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

NCT06537128 | Recruiting

• 1 other identifier: H-55617
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Autism; Anxiety; Anxiety Disorders; Generalized Anxiety Disorder; Social Anxiety Disorder

Keywords

Cognitive Behavioral Therapy; Adolescents; Autism; Anxiety

Outcome Measures

Primary Outcomes (1)

• Pediatric Anxiety Rating Scale modified for ASD (PARS-ASD)

  Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35. This measure has been modified for autistic youth

  Baseline (before treatment), during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up

Secondary Outcomes (2)

• Clinical Global Impression-Improvement (CGI-I)

  during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up

• Screen for Child Anxiety Related Disorders (SCARED)

  Baseline (before treatment), post-treatment (on average 12 weeks), 1 month follow up

Study Arms (2)

LUNA-Adolescent

ACTIVE COMPARATOR

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.

Behavioral: LUNA-Adolescent

Treatment as Usual

PLACEBO COMPARATOR

Dyads in the standard-care cognitive behavioral therapy (CBT) group will receive 12 weekly sessions of transdiagnostic CBT for anxiety in autistic youth.

Behavioral: Treatment as Usual

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.

Also known as: Internet-based Cognitive Behavioral Therapy

LUNA-Adolescent

Treatment as Usual BEHAVIORAL

Treatment as Usual includes 12 weekly sessions of transdiagnostic cognitive behavioral therapy (CBT) for anxiety in autistic youth.

Treatment as Usual

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child is between the age of 11-17 years old at enrollment.
• The child is diagnosed with autism using a validated assessment (e.g., Autism Diagnostic Observation Schedule-Second Edition (ADOS-2), Childhood Autism Rating Scale-Second Edition (CARS-2), etc.).
• The child has current, clinically significant anxiety and/or OCD as indicated by a clinician-administered standardized assessment (e.g. Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) and Pediatric Rating Anxiety Scale modified for autism (PARS-ASD)).
• Anxiety disorder is the child's primary/co-primary psychiatric diagnosis, and if secondary psychopathology is present, it will not interfere with treatment.
• One parent/guardian over the age of 18 is able and willing to participate in assessment and treatment (e.g. has sufficient English/Spanish fluency, the decisional capacity to participate, and can commit to treatment duration).
• The child is able to communicate verbally.
• Participants are located in Texas.
• The participant has an IQ above 69, based on the Kaufman Brief Intelligence Test-Second Edition (KBIT-2), another valid test or clinician judgement (e.g., a previous assessment conducted, and report shared with study team)

You may not qualify if:

• The child has a diagnosis of a lifetime psychotic disorder and/or conduct disorder.
• The child has significant, current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
• The child has limited verbal communication abilities (e.g., no independent verbal communication),
• The child is receiving concurrent psychotherapy (including certain forms of social skills training, or behavioral interventions that target anxiety such as applied behavioral analysis).
• The child has initiated new antidepressant medication within 12-weeks of assessment (4-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
• The child has changed psychotropic medication dosage within 4-weeks of assessment (2-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
• The child requires a higher level than can be provided through the study (e.g., significant, current suicidal ideation)

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Anxiety Disorders; Generalized Anxiety Disorder; Phobia, Social

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Phobic Disorders

Study Officials

• Eric Storch, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Callie Murphy, B.A.

CONTACT

713-798-6114; callie.murphy@bcm.edu

Jolie Held, BA

CONTACT

713-198-3080; Jolie.Held@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators will be blind to which group participants are randomized into.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized assignment to one of two conditions

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: November 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)