Cognitive Behavioral TherapyNCT05284435
Internet-Based, Parent-Led Cognitive-Behavioral Therapy for Anxiety in Youth With ASD
A study testing Cognitive Behavioral Therapy-Email (iCBT-E) and Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV) in people with Cognitive Behavioral Therapy and Autism Spectrum Disorder, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This study compares the effectiveness of two levels of therapist support for an internet-based, parent-led cognitive behavioral therapy for youth with anxiety and ASD. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Cognitive Behavioral Therapy, Autism Spectrum Disorder, Anxiety Disorder
- What is being tested?
- Cognitive Behavioral Therapy-Email (iCBT-E) and Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 17 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is between the ages 7-15 years at consent/assent.
- The child meets criteria for ASD.
- The child meets criteria for an anxiety and/or obsessive compulsive disorder (OCD) as determined by the Mini Neuropsychiatric Interview for Children and Adolescents
- Anxiety and/or OCD is the primary presenting problem as determined by the Mini Neuropsychiatric Interview for Children and Adolescents
- One parent/guardian is able and willing to participate.
- The child has a Full Scale and Verbal Comprehension Intelligence Quotient >70.
- The child is able to communicate verbally.
- Participants must reside in Texas and must be in the state of Texas when taking calls.
Who cannot join
- The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability.
- The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
- The child is receiving concurrent psychotherapy for anxiety.
- Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the effectiveness of two levels of therapist support for an internet-based, parent-led cognitive behavioral therapy for youth with anxiety and ASD.
Read the detailed description
Autism spectrum disorder, or ASD, is one of the most common neurodevelopmental disorders, affecting up to 1 out of 59 youth in the United States. Anxiety disorders affect 50-80% of children with ASD and are associated with significant life impairment and worsening trajectory without treatment. Cognitive-behavioral therapy (CBT) is an effective treatment for anxiety, yet access to CBT is very limited for most families due to the cost, practicalities of attending in-person treatment sessions and limited availability of trained therapists. Access to CBT is particularly limited for Hispanic or Spanish-speaking families due to lack of services provided in Spanish. Web-based or internet-based delivery of services is a promising method to improve access to care for youth with ASD and their families, given its reachability to a wider range of areas (e.g., rural/underserved) and its ability to minimize practical barriers (e.g., treatment could be delivered to home without need for travel), and reduce stigma (e.g., parents do not need to visit mental health clinics). Thus, the goal of this project is to increase access to care for families of children with ASD and anxiety through an internet-based treatment intervention model. This intervention, developed by the study team, consists of an interactive website with treatment materials that parents can work through with their child, both in English and Spanish.
Specifically, this project will examine the effectiveness of an internet-based, parent-led cognitive-behavioral therapy (iCBT) for anxiety in children with two levels of therapist support: 1) iCBT-E (therapist support is delivered via email) and 2) iCBT-EV (therapist support is delivered via email and videoconferencing sessions).
This study will also involve two phases: 1) pilot intervention phase and 2) randomized controlled phase.
- Conditions
- Cognitive Behavioral Therapy, Autism Spectrum Disorder, Anxiety Disorder, Obsessive-Compulsive Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder
- Being tested
- Cognitive Behavioral Therapy-Email (iCBT-E), Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders, Obsessive-Compulsive Disorder, Phobia, Social, Generalized Anxiety Disorder, Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy-Email (iCBT-E)Behavioural
Participating families will receive an access to the website that contains treatment materials for both parent and child.
During each of the weekly emails, therapists will serve to provide encouragement and support as the parent works through the program independently.
Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)Behavioural
Participating families will receive an access to the website that contains treatment materials for both parent and child.
During each of the weekly emails and six videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently. Therapists will also assist the parent with any problem-solving as needed.
| Study group | Role | What they receive |
|---|---|---|
| iCBT-Email (iCBT-E) | Experimental | Parents will receive a weekly email from a therapist over the 12 weeks of treatment. Receives: Behavioral: Cognitive Behavioral Therapy-Email (iCBT-E) |
| iCBT-Email and Videoconferencing (iCBT-EV) | Active comparator | Parents will receive a weekly email and six 30-minute supportive video calls with a therapist over the 12 weeks of treatment. Receives: Behavioral: Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-item Pediatric Anxiety Rating Scale - Autism Spectrum Disorder
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 30.
Measured: 7 days
Clinical Global Impression-Improvement
Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).
Measured: 7 days
Secondary outcomes (4)
Revised Child Anxiety and Depression Scale- Parent-Report- Anxiety Subscale
Parent rated child anxiety severity. It is a 37-item scale and each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 to 111.
Measured: 7 days
Revised Child Anxiety and Depression Scale- Self-Report- Anxiety Subscale
Child rated anxiety severity. It is a 37-item scale and each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 to 111.
Measured: 7 days
Social Responsiveness Scale, Second Edition
Parent rated child impairment in social behaviors. It is a 65-item scale and each item is scored on a 1 ("not true") to 4 ("almost always true") scale (higher scores correspond to greater impairment), yielding a total raw score between 65 and 260.
Measured: 7 days
Sheehan Disability Scale
Parent rated child functional impairment. It is a 5-item scale and each item is scored on a 0 ("not at all") to 10 ("extremely") scale (higher scores correspond to greater impairment), yielding a total between 0 and 50.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start28 Mar 2022
- Primary completion21 Aug 2023
- Study completion17 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive Behavioral TherapyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Guzick, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284435
- Sponsor's protocol ID
- H-51359
- Status last verified
- Dec 2023
- First submitted
- 9 Mar 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guzick AG, Schneider SC, Kook M, Greenberg R, Perozo-Garcia A, Lee MP, Garcia J, Onyeka OC, Riddle DB, Storch EA. Internet-based, parent-led cognitive behavioral therapy for autistic youth with anxiety-related disorders: A randomized trial comparing email vs. telehealth support. Behav Res Ther. 2024 Dec;183:104639. doi: 10.1016/j.brat.2024.104639. Epub 2024 Sep 29.
PubMed 39368459
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based, Parent-Led Cognitive-Behavioral Therapy for Anxiety in Youth With ASD
- ClinicalTrials.gov ID
- NCT05284435
- Acronym / sponsor ID
- H-51359
- Conditions
- Cognitive Behavioral Therapy, Autism Spectrum Disorder, Anxiety Disorder, Obsessive-Compulsive Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 17 Dec 2023 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the effectiveness of two levels of therapist support for an internet-based, parent-led cognitive behavioral therapy for youth with anxiety and ASD.
Detailed description
Autism spectrum disorder, or ASD, is one of the most common neurodevelopmental disorders, affecting up to 1 out of 59 youth in the United States. Anxiety disorders affect 50-80% of children with ASD and are associated with significant life impairment and worsening trajectory without treatment. Cognitive-behavioral therapy (CBT) is an effective treatment for anxiety, yet access to CBT is very limited for most families due to the cost, practicalities of attending in-person treatment sessions and limited availability of trained therapists. Access to CBT is particularly limited for Hispanic or Spanish-speaking families due to lack of services provided in Spanish. Web-based or internet-based delivery of services is a promising method to improve access to care for youth with ASD and their families, given its reachability to a wider range of areas (e.g., rural/underserved) and its ability to minimize practical barriers (e.g., treatment could be delivered to home without need for travel), and reduce stigma (e.g., parents do not need to visit mental health clinics). Thus, the goal of this project is to increase access to care for families of children with ASD and anxiety through an internet-based treatment intervention model. This intervention, developed by the study team, consists of an interactive website with treatment materials that parents can work through with their child, both in English and Spanish.
Specifically, this project will examine the effectiveness of an internet-based, parent-led cognitive-behavioral therapy (iCBT) for anxiety in children with two levels of therapist support: 1) iCBT-E (therapist support is delivered via email) and 2) iCBT-EV (therapist support is delivered via email and videoconferencing sessions).
This study will also involve two phases: 1) pilot intervention phase and 2) randomized controlled phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCBT-Email (iCBT-E) | Experimental | Behavioral: Cognitive Behavioral Therapy-Email (iCBT-E)Parents will receive a weekly email from a therapist over the 12 weeks of treatment. |
| iCBT-Email and Videoconferencing (iCBT-EV) | Active comparator | Behavioral: Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)Parents will receive a weekly email and six 30-minute supportive video calls with a therapist over the 12 weeks of treatment. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child is between the ages 7-15 years at consent/assent.
- The child meets criteria for ASD.
- The child meets criteria for an anxiety and/or obsessive compulsive disorder (OCD) as determined by the Mini Neuropsychiatric Interview for Children and Adolescents
- Anxiety and/or OCD is the primary presenting problem as determined by the Mini Neuropsychiatric Interview for Children and Adolescents
- One parent/guardian is able and willing to participate.
Key exclusion criteria (4 listed)
- The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability.
- The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
- The child is receiving concurrent psychotherapy for anxiety.
- Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy-Email (iCBT-E)Participating families will receive an access to the website that contains treatment materials for both parent and child. During each of the weekly emails, therapists will serve to provide encouragement and support as the parent works through the program independently. | Behavioural | iCBT-Email (iCBT-E) |
| Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV)Participating families will receive an access to the website that contains treatment materials for both parent and child. During each of the weekly emails and six videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently. Therapists will also assist the parent with any problem-solving as needed. | Behavioural | iCBT-Email and Videoconferencing (iCBT-EV) |
Primary outcome
5-item Pediatric Anxiety Rating Scale - Autism Spectrum Disorder
Time frame: 7 days
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 30.
Clinical Global Impression-Improvement
Time frame: 7 days
Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).
4 secondary outcomes
Revised Child Anxiety and Depression Scale- Parent-Report- Anxiety Subscale
Time frame: 7 days
Revised Child Anxiety and Depression Scale- Self-Report- Anxiety Subscale
Time frame: 7 days
Social Responsiveness Scale, Second Edition
Time frame: 7 days
Sheehan Disability Scale
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Derived from this study: PubMed 39368459Guzick AG, Schneider SC, Kook M, Greenberg R, Perozo-Garcia A, Lee MP, Garcia J, Onyeka OC, Riddle DB, Storch EA. Internet-based, parent-led cognitive behavioral therapy for autistic youth with anxiety-related disorders: A randomized trial comparing email vs. telehealth support. Behav Res Ther. 2024 Dec;183:104639. doi: 10.1016/j.brat.2024.104639. Epub 2024 Sep 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy-Email (iCBT-E) and Cognitive Behavioral Therapy-Email and Videoconferencing (iCBT-EV) in people with Cognitive Behavioral Therapy and Autism Spectrum Disorder, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-item Pediatric Anxiety Rating Scale - Autism Spectrum Disorder (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05284435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.