Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety (LUNA-A)

June 26, 2026 updated by: Eric A Storch, Baylor College of Medicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Autism affects 2-3% of youth, approximately half of whom experience a co-occurring anxiety disorder. Anxiety disorders in autistic youth are associated with significant life impairment and worsening trajectory without treatment. 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. Access to CBT is particularly limited for Hispanic or Spanish-speaking families due to lack of services provided in Spanish. Internet-delivered therapies such as iCBT provide low intensity but effective intervention and overcomes barriers such as cost, travel, time from work/school, and stigma. Studies suggest that iCBT protocols for anxious typically-developing youth demonstrate moderate to strong effect sizes relative to control groups. However, until recently, such treatment models have not been developed with stakeholder engagement to be personalized for autistic children with anxiety and their families, including for those families that speak Spanish. In a previous Texas Higher Education Coordinating Board (THECB) funded work, a parent-led iCBT intervention for anxiety among autistic youth, Learning to Understand and Navigate Anxiety (LUNA) was developed. Over 60% of participants demonstrated response to treatment, yet children responded better than adolescents. Family feedback indicated that the materials were not developmentally appropriate for adolescents, necessitating further efforts to develop and evaluate an adapted version which is personalized to the unique needs of autistic adolescents with anxiety. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model (LUNA-Adolescent). This treatment model, developed by the study team, consists of an interactive website with both parent- and adolescent-facing treatment materials, supported by brief therapist contact (e.g. telehealth sessions), both in English and Spanish. Specifically, this project will evaluate the efficacy and cost effectiveness of LUNA-Adolescent compared to standard-care CBT for anxiety. Overall, this study will provide important information regarding the potential benefits of internet-based, parent-led interventions for autistic adolescents with anxiety and its two different delivery models.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion 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)

Exclusion Criteria:

  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Treatment as Usual
Treatment as Usual includes 12 weekly sessions of transdiagnostic cognitive behavioral therapy (CBT) for anxiety in autistic youth.
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.
Behavioral: LUNA-Adolescent
Learning to Understand and Navigate Anxiety-Adolescent (LUNA-Adolescent) includes parent-led, internet-based cognitive behavioral therapy (CBT) for anxiety among autistic youth.
Other Names:
  • Internet-based Cognitive Behavioral Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Global Impression-Improvement (CGI-I)
Time Frame: during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up
Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= very much improved; 6= very much worse).
during treatment (on average 6 weeks), post-treatment (on average 12 weeks), 1 month follow up
Screen for Child Anxiety Related Disorders (SCARED)
Time Frame: Baseline (before treatment), post-treatment (on average 12 weeks), 1 month follow up
Parent and child self-report measure assessing anxiety symptoms including subscales for separation anxiety disorder, generalized anxiety disorder, social anxiety disorder, panic disorder or significant somatic symptoms, and significant school avoidance. A single item is scored on a 3 point Likert scale ranging from 0 (not true or hardly ever true) to 2 (very true or often true).
Baseline (before treatment), post-treatment (on average 12 weeks), 1 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor College of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Storch, PhD, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-55617

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings