Cognitive Behavioral TherapyNCT04111874

Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD

A study testing Cognitive Behavioral Teletherapy LTA and Cognitive Behavioral Teletherapy STA in people with Cognitive Behavioral Therapy and Autism Spectrum Disorder, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study implements an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety. Read more about this study

Who is it for?: Ages 7 to 13 years
Conditions the study is for: Cognitive Behavioral Therapy, Autism Spectrum Disorder, Anxiety Disorders
What is being tested?: Cognitive Behavioral Teletherapy LTA and Cognitive Behavioral Teletherapy STA
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteUnited States
Study dates: 30 Jul 2019to 31 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 13 years
All sexes
No healthy volunteers
Child

Who may be able to join

Child is between the ages 7-13 years at consent/assent.
The child meets criteria for ASD.
The child meets criteria for clinically significant anxiety and/or OCD symptoms.
Anxiety and/or OCD is the primary presenting problem.
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 parents 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.

United States1 site

Baylor College of Medicine
Houston, Texas, 77030

Other trials in United States

About this study

This study implements an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety.

Read the detailed description

Anxiety disorders affect 50-80% of children with autism spectrum disorder (ASD) and are associated with significant life impairment and worsening trajectory without treatment. The most effective psychotherapy for anxiety in youth with and without ASD is cognitive behavioral therapy (CBT), but many families are not able to access CBT due to the cost, practicalities of attending treatment sessions, and limited availability of trained therapists. Alternative models of service delivery are greatly needed, with particular promise of parent-led therapist-assisted (PLTA) models and telehealth delivery formats. Parents may benefit from additional information regarding how to optimize the delivery of CBT for youths with ASD given the potential impact of ASD symptomology on core CBT skills. Thus, this project aims to improve access to anxiety-focused Parent-Led Therapist-Assisted CBT for parents of youth with ASD. Parent-led low-intensity treatment models can improve accessibility, efficiency, and mental health treatment cost. Lower intensity treatment models provide a treatment option that is less costly and burdensome for parents; it is understood that some individuals will respond to the first step and others will require additional treatment to achieve anxiety reduction. However, understanding how many families, and which families, can benefit from a lower intensity model has dramatic benefits for improving access, allocating more intensive services for those most in need, and reducing barriers (e.g., distance). Thus, this study will examine the effectiveness of two anxiety-focused PTLA CBT telehealth models: 1) low-intensity therapist assistance (LTA) and 2) standard therapist assistance (STA). Overall, this study will provide important information regarding the potential benefits of two different approaches to parent-led interventions for youth with ASD and anxiety when delivered via telehealth.

Conditions: Cognitive Behavioral Therapy, Autism Spectrum Disorder, Anxiety Disorders, Obsessive-Compulsive Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder
Being tested: Cognitive Behavioral Teletherapy LTA, Cognitive Behavioral Teletherapy STA
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 Teletherapy LTABehavioural
Participating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.
Cognitive Behavioral Teletherapy STABehavioural
Participating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed.

Study groups in NCT04111874
Study group	Role	What they receive
Low-Intensity Therapist Assistance (LTA)	Experimental	Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment. Receives: Behavioral: Cognitive Behavioral Teletherapy LTA
Standard Therapist Assistance (STA)	Active comparator	Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment. Receives: Behavioral: Cognitive Behavioral Teletherapy STA

What is being measured

The primary outcome is the main question the study is designed to answer.

6-item Pediatric Anxiety Rating Scale
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: Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.
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: Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.

Secondary outcomes (1)

Clinical Global Impression-Severity
Clinician rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
Measured: Baseline (before treatment), Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 201931 Dec 2023

First posted1 Oct 2019
Study start30 Jul 2019
Primary completion31 Dec 2022
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)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: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04111874
Sponsor's protocol ID: H45203
Status last verified: Dec 2024
First submitted: 30 Sep 2019
Last updated: 15 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Guzick AG, Schneider SC, Kook M, Rose Iacono J, Weinzimmer SA, Quast T, Olsen SM, Hughes KR, Jellinek-Russo E, Garcia AP, Candelari A, Berry LN, Goin-Kochel RP, Goodman WK, Storch EA. Parent-Led Cognitive Behavioral Teletherapy for Anxiety in Autistic Youth: A Randomized Trial Comparing Two Levels of Therapist Support. Behav Ther. 2024 May;55(3):499-512. doi: 10.1016/j.beth.2023.08.008. Epub 2023 Sep 6.
PubMed 38670664
Greenberg RL, Guzick AG, Schneider SC, Weinzimmer SA, Kook M, Perozo Garcia AB, Storch EA. Depressive Symptoms in Autistic Youth with Anxiety Disorders. J Dev Behav Pediatr. 2023 Dec 1;44(9):e597-e603. doi: 10.1097/DBP.0000000000001223. Epub 2023 Oct 11.
PubMed 38019467
Elliott SJ, Marshall D, Morley K, Uphoff E, Kumar M, Meader N. Behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in individuals with autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2021 Sep 3;9(9):CD013173. doi: 10.1002/14651858.CD013173.pub2.
PubMed 34693989

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Psychological Treatments for Youth With Severe Irritability.
Irritability
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury

All Cognitive Behavioral Therapy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD
ClinicalTrials.gov ID: NCT04111874
Acronym / sponsor ID: H45203
Conditions: Cognitive Behavioral Therapy, Autism Spectrum Disorder, Anxiety Disorders, Obsessive-Compulsive Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Study start: 30 Jul 2019 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 1 Oct 2019 (actual)
Results: Posted 15 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study implements an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Low-Intensity Therapist Assistance (LTA)	Experimental	Behavioral: Cognitive Behavioral Teletherapy LTAParents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment.
Standard Therapist Assistance (STA)	Active comparator	Behavioral: Cognitive Behavioral Teletherapy STAParents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment.

Who may qualify

Ages: 7 to 13 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Child is between the ages 7-13 years at consent/assent.
The child meets criteria for ASD.
The child meets criteria for clinically significant anxiety and/or OCD symptoms.
Anxiety and/or OCD is the primary presenting problem.
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 Teletherapy LTAParticipating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.	Behavioural	Low-Intensity Therapist Assistance (LTA)
Cognitive Behavioral Teletherapy STAParticipating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed.	Behavioural	Standard Therapist Assistance (STA)

Primary outcome

6-item Pediatric Anxiety Rating Scale
Time frame: Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.
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: Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.
Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).

1 secondary outcome

Clinical Global Impression-Severity
Time frame: Baseline (before treatment), Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.

Results and safety

Results posted to the registry on 15 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low-Intensity Therapist Assistance (LTA)	48	31
Standard Therapist Assistance (STA)	39	35

Primary outcome: 6-item Pediatric Anxiety Rating Scale

Time frame: Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.. Mean (Standard Deviation). Unit: Score on a scale

Measure	Low-Intensity Therapist Assistance (LTA) n = 31	Standard Therapist Assistance (STA) n = 33
Value	11.35 (5.36)	10.26 (4.17)

Population analysed: Results for the post-treatment assessment

Primary outcome: Clinical Global Impression-Improvement

Time frame: Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.. Count of participants. Unit: Participants

Measure	Low-Intensity Therapist Assistance (LTA) n = 31	Standard Therapist Assistance (STA) n = 33
Value	21	23

Population analysed: count of participants who were classified as "much" or "very much improved" on the CGI-I at the end of treatment

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Participants were enrolled in the study for up to 6 months, which corresponds to the time that adverse event data were collected. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low-Intensity Therapist Assistance (LTA)	0 of 48 (0%)	0 of 48 (0%)	0 of 48
Standard Therapist Assistance (STA)	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38670664Guzick AG, Schneider SC, Kook M, Rose Iacono J, Weinzimmer SA, Quast T, Olsen SM, Hughes KR, Jellinek-Russo E, Garcia AP, Candelari A, Berry LN, Goin-Kochel RP, Goodman WK, Storch EA. Parent-Led Cognitive Behavioral Teletherapy for Anxiety in Autistic Youth: A Randomized Trial Comparing Two Levels of Therapist Support. Behav Ther. 2024 May;55(3):499-512. doi: 10.1016/j.beth.2023.08.008. Epub 2023 Sep 6.
Derived from this study: PubMed 38019467Greenberg RL, Guzick AG, Schneider SC, Weinzimmer SA, Kook M, Perozo Garcia AB, Storch EA. Depressive Symptoms in Autistic Youth with Anxiety Disorders. J Dev Behav Pediatr. 2023 Dec 1;44(9):e597-e603. doi: 10.1097/DBP.0000000000001223. Epub 2023 Oct 11.
Derived from this study: PubMed 34693989Elliott SJ, Marshall D, Morley K, Uphoff E, Kumar M, Meader N. Behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in individuals with autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2021 Sep 3;9(9):CD013173. doi: 10.1002/14651858.CD013173.pub2.
Individual participant dataSharing planned: No

Related trials for Cognitive Behavioral Therapy

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Psychological Treatments for Youth With Severe Irritability.
Irritability
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury

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?

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 15 Jan 2025. 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?

Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

6-item Pediatric Anxiety Rating Scale (time frame: Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.). 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 NCT04111874, which also lists 3 linked publications.

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 15 Jan 2025.