RECRUITING

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

Conditions

Autism Spectrum Disorder Autism Anxiety Anxiety Disorders Generalized Anxiety Disorder Social Anxiety Disorder Cognitive Behavioral Therapy Adolescents

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Internet-delivered Cognitive-Behavioral Therapy for Adolescents with Autism and Anxiety: Development and Evaluation of Learning to Understand and Navigate Anxiety-Adolescent

Quick Facts

Study Start:2024-11-01

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06537128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. The child is between the age of 11-17 years old at enrollment. 2. 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.). 3. 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)). 4. Anxiety disorder is the child's primary/co-primary psychiatric diagnosis, and if secondary psychopathology is present, it will not interfere with treatment. 5. 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). 6. The child is able to communicate verbally. 7. Participants are located in Texas. 8. 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)	1. The child has a diagnosis of a lifetime psychotic disorder and/or conduct disorder. 2. The child has significant, current suicidal/homicidal ideation and/or self-injury requiring medical intervention. 3. The child has limited verbal communication abilities (e.g., no independent verbal communication), 4. The child is receiving concurrent psychotherapy (including certain forms of social skills training, or behavioral interventions that target anxiety such as applied behavioral analysis). 5. The child has initiated new antidepressant medication within 12-weeks of assessment (4-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy. 6. The child has changed psychotropic medication dosage within 4-weeks of assessment (2-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy. 7. The child requires a higher level than can be provided through the study (e.g., significant, current suicidal ideation)

Inclusion Criteria

Exclusion Criteria

1. The child is between the age of 11-17 years old at enrollment.
2. 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.).
3. 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)).
4. Anxiety disorder is the child's primary/co-primary psychiatric diagnosis, and if secondary psychopathology is present, it will not interfere with treatment.
5. 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).
6. The child is able to communicate verbally.
7. Participants are located in Texas.
8. 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)

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

Contacts and Locations

Study Contact

Callie Murphy, B.A.

CONTACT

713-798-6114

callie.murphy@bcm.edu

Eric Storch, Ph.D.

CONTACT

713-198-3080

eric.storch@bcm.edu

Study Locations (Sites)

Baylor College of Medicine

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-11-01

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

Cognitive Behavioral Therapy
Adolescents
Autism
Anxiety

Additional Relevant MeSH Terms

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