Obsessive Compulsive Disorder (OCD)ASTRONCT07024758
Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
A study testing Parent Coached Exposure Therapy and Family Based, Internet-Based Cognitive Behavioral Therapy in people with Obsessive Compulsive Disorder (OCD) and Anxiety Disorder of Childhood or Adolescence, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Anxiety disorders in children and adolescents are common and confer significant disability. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD), Anxiety Disorder of Childhood or Adolescence, Social Anxiety Disorder of Childhood
- What is being tested?
- Parent Coached Exposure Therapy and Family Based, Internet-Based Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child is between the ages of 7 to 17 years inclusive at enrollment.
- The child has clinically significant symptoms of anxiety and/or OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).
- The child is appropriate for anxiety-focused treatment (e.g., anxiety or OCD is the primary or co-primary problem as diagnosed using the DIAMOND-KID).
- One parent/guardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).
- The participating parent/guardian lives with their child at least 50% of the time per self-report.
- Both parent and child can read and understand English.
- The participant has an IQ above 69, based on the KBIT-2, another valid test or clinician judgement (e.g., a previous assessment conducted, and report shared with study team).
- Participants must be in the state of Texas for treatment sessions/assessments.
Who cannot join
- The child has a diagnosis of a lifetime psychotic disorder and/or conduct disorder.
- The child has significant, current and active suicidality/homicidality 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 with anxiety and/or OCD as the primary focus. They can pause ongoing therapy to enroll.
- 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 of care than can be provided through the study (e.g., significant, current suicidal ideation).
Trial locations and contacts
1 site in 1 country.
About this study
Anxiety disorders in children and adolescents are common and confer significant disability. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. To combat these barriers, other treatment methods have been developed.
Previous research has shown that family-based, internet-delivered CBT (iCBT) for anxiety and OCD in youth has shown a significant reduction in anxiety symptoms. Parent-coached exposure therapy (PCET) focuses entirely on teaching parents and youth together how to address anxiety through the completion of in-session parent-coached exposures and assigning parent-coached exposure as homework in between sessions.
Read more
Although both iCBT and PCET show positive results in treating pediatric anxiety in comparison to standard-care CBT, little is known about the comparative efficacy of iCBT and PCET.
This research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD in youth.
Read the detailed description
Anxiety disorders in children and adolescents are common and confer significant disability. Without treatment, anxiety remains chronic and contributes to increased risk for later suicidality, mood, and substance use disorders. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. To combat these barriers, other treatment methods have been developed.
Low intensity telehealth delivery of services is a promising method to improve access to care for youth with anxiety 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 the youth's home without need for travel), and reduce stigma (e.g., parents do not need to visit mental health clinics). Previous research has shown that family-based, internet-delivered CBT (iCBT) for anxiety and OCD in youth has shown a significant reduction in anxiety symptoms.
Parent-coached exposure therapy (PCET) focuses entirely on teaching parents and youth together how to address anxiety through the completion of in-session parent-coached exposures and assigning parent-coached exposure as homework in between sessions. PCET is designed to treat anxiety more effectively and efficiently, allowing for fewer sessions and greater symptom remission than standard-care CBT.
Although both iCBT and PCET show positive results in treating pediatric anxiety in comparison to standard-care CBT, little is known about the comparative efficacy of iCBT and PCET.
This research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD in youth.
- Conditions
- Obsessive Compulsive Disorder (OCD), Anxiety Disorder of Childhood or Adolescence, Social Anxiety Disorder of Childhood, Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder, Panic Disorder
- Being tested
- Parent Coached Exposure Therapy, Family Based, Internet-Based Cognitive Behavioral Therapy
- Keywords
- Obsessive-compulsive disorder, anxiety, cognitive-behavioral therapy, children, adolescents
- Medical subject headings
- Obsessive-Compulsive Disorder, Generalized Anxiety Disorder, Anxiety, Separation, Panic Disorder, Phobia, Specific, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Coached Exposure TherapyBehavioural
Parent-based cognitive behavioral therapy with guidance from a therapist
Family Based, Internet-Based Cognitive Behavioral TherapyBehavioural
Family-based cognitive behavioral therapy employing internet-delivered modules and videos
| Study group | Role | What they receive |
|---|---|---|
| Parent Coached Exposure Therapy (PCET) | Active comparator | Parent Coached Exposure Therapy (PCET) consists of 12 weekly individual sessions that are attended by the therapist, child, and parent. Sessions will follow the cognitive behavioral therapy model of childhood anxiety disorders, wherein safety behaviors and avoidance reinforce anxiety, explains the rationale of exposure, and begins developing an exposure hierarchy with the family. Sessions will include psychoeducation, developing an exposure hierarchy, carrying out in-session exposures, and assigning exposures in between sessions. Receives: Behavioral: Parent Coached Exposure Therapy |
| Family-Based Internet-Based CBT Group (iCBT) | Active comparator | One half of participants will be randomized to receive iCBT. Each week of treatment, the parent will be encouraged to read the corresponding materials on the Baylor College of Medicine (BCM) webpage, complete accompanying worksheets, and guide their child through completing activities in the child-facing materials, with support from a therapist (7 45-minute supportive therapy sessions). One core aspect of treatment will be parents leading their child through graduated exposure. Exposures, a hallmark of CBT for anxiety, are used to gradually and repeatedly confront feared stimuli. For example, exposure therapy for a child fearful of dogs may begin with looking at pictures of dogs and standing across the park from a dog on a leash, to eventually petting a dog. All relevant information regarding parent-led exposures will be detailed in the treatment materials, and therapists will review with parents via email and/or video-conferencing sessions. Receives: Behavioral: Family Based, Internet-Based Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinician-rated child anxiety severity (PARS) 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 or week 1), post-treatment (week 14), 1 month follow up (Week 18)
Secondary outcomes (2)
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) with Clinical Severity Ratings
Clinician-rated diagnostic interview that includes current anxiety disorders, mood disorders, obsessive-compulsive disorder, and related neuropsychiatric disorders. Each diagnostic category is coded as present or absent based on symptom criteria and severity scale. Severity scales are scored on a 1-7 scale (1 = normal; 7 = extreme) and are based on current level of distress and impairment (within the past month).
Measured: baseline (before treatment or week 1), post-treatment (week 14), 1 month follow up (Week 18)
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 or Week 1), during treatment (on average 14 weeks), post-treatment (Week 14), 1 month follow up (Week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies 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
- Model description
- Children (N=174) ages 7-17 will be randomized into one of two conditions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric A Storch, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024758
- Sponsor's protocol ID
- H-57367
- Acronym
- ASTRO
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whiteside SPH, Biggs BK, Geske JR, Gloe LM, Reneson-Feeder ST, Cunningham M, Dammann JE, Brennan E, Ong ML, Olsen MW, Hofschulte DR. Parent-coached exposure therapy versus cognitive behavior therapy for childhood anxiety disorders. J Anxiety Disord. 2024 Jun;104:102877. doi: 10.1016/j.janxdis.2024.102877. Epub 2024 May 18.
PubMed 38788593Guzick AG, Schneider SC, Perozo Garcia AB, Kook M, Greenberg RL, Riddle D, McNeel M, Rodriguez-Barajas S, Yang M, Upshaw B, Storch EA. Development and pilot testing of internet-delivered, family-based cognitive behavioral therapy for anxiety and obsessive-compulsive disorders in autistic youth. J Obsessive Compuls Relat Disord. 2023 Apr;37:100789. doi: 10.1016/j.jocrd.2023.100789. Epub 2023 Feb 14.
PubMed 36908861
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
- ClinicalTrials.gov ID
- NCT07024758
- Acronym / sponsor ID
- ASTRO / H-57367
- Conditions
- Obsessive Compulsive Disorder (OCD), Anxiety Disorder of Childhood or Adolescence, Social Anxiety Disorder of Childhood, Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder, Panic Disorder
- Keywords
- Obsessive-compulsive disorder, anxiety, cognitive-behavioral therapy, children, adolescents
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Jun 2025 (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.
Anxiety disorders in children and adolescents are common and confer significant disability. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. To combat these barriers, other treatment methods have been developed.
Previous research has shown that family-based, internet-delivered CBT (iCBT) for anxiety and OCD in youth has shown a significant reduction in anxiety symptoms. Parent-coached exposure therapy (PCET) focuses entirely on teaching parents and youth together how to address anxiety through the completion of in-session parent-coached exposures and assigning parent-coached exposure as homework in between sessions.
Although both iCBT and PCET show positive results in treating pediatric anxiety in comparison to standard-care CBT, little is known about the comparative efficacy of iCBT and PCET.
This research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD in youth.
Detailed description
Anxiety disorders in children and adolescents are common and confer significant disability. Without treatment, anxiety remains chronic and contributes to increased risk for later suicidality, mood, and substance use disorders. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. To combat these barriers, other treatment methods have been developed.
Low intensity telehealth delivery of services is a promising method to improve access to care for youth with anxiety 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 the youth's home without need for travel), and reduce stigma (e.g., parents do not need to visit mental health clinics). Previous research has shown that family-based, internet-delivered CBT (iCBT) for anxiety and OCD in youth has shown a significant reduction in anxiety symptoms.
Parent-coached exposure therapy (PCET) focuses entirely on teaching parents and youth together how to address anxiety through the completion of in-session parent-coached exposures and assigning parent-coached exposure as homework in between sessions. PCET is designed to treat anxiety more effectively and efficiently, allowing for fewer sessions and greater symptom remission than standard-care CBT.
Although both iCBT and PCET show positive results in treating pediatric anxiety in comparison to standard-care CBT, little is known about the comparative efficacy of iCBT and PCET.
This research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD in youth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Children (N=174) ages 7-17 will be randomized into one of two conditions.
| Arm | Type | Receives |
|---|---|---|
| Parent Coached Exposure Therapy (PCET) | Active comparator | Behavioral: Parent Coached Exposure TherapyParent Coached Exposure Therapy (PCET) consists of 12 weekly individual sessions that are attended by the therapist, child, and parent. Sessions will follow the cognitive behavioral therapy model of childhood anxiety disorders, wherein safety behaviors and avoidance reinforce anxiety, explains the rationale of exposure, and begins developing an exposure hierarchy with the family. Sessions will include psychoeducation, developing an exposure hierarchy, carrying out in-session exposures, and assigning exposures in between sessions. |
| Family-Based Internet-Based CBT Group (iCBT) | Active comparator | Behavioral: Family Based, Internet-Based Cognitive Behavioral TherapyOne half of participants will be randomized to receive iCBT. Each week of treatment, the parent will be encouraged to read the corresponding materials on the Baylor College of Medicine (BCM) webpage, complete accompanying worksheets, and guide their child through completing activities in the child-facing materials, with support from a therapist (7 45-minute supportive therapy sessions). One core aspect of treatment will be parents leading their child through graduated exposure. Exposures, a hallmark of CBT for anxiety, are used to gradually and repeatedly confront feared stimuli. For example, exposure therapy for a child fearful of dogs may begin with looking at pictures of dogs and standing across the park from a dog on a leash, to eventually petting a dog. All relevant information regarding parent-led exposures will be detailed in the treatment materials, and therapists will review with parents via email and/or video-conferencing sessions. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The child is between the ages of 7 to 17 years inclusive at enrollment.
- The child has clinically significant symptoms of anxiety and/or OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).
- The child is appropriate for anxiety-focused treatment (e.g., anxiety or OCD is the primary or co-primary problem as diagnosed using the DIAMOND-KID).
- One parent/guardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).
- The participating parent/guardian lives with their child at least 50% of the time per self-report.
Key exclusion criteria (7 listed)
- The child has a diagnosis of a lifetime psychotic disorder and/or conduct disorder.
- The child has significant, current and active suicidality/homicidality 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 with anxiety and/or OCD as the primary focus. They can pause ongoing therapy to enroll.
- The child has initiated new antidepressant medication within 12-weeks of assessment (4-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
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 |
|---|---|---|
| Parent Coached Exposure TherapyParent-based cognitive behavioral therapy with guidance from a therapist | Behavioural | Parent Coached Exposure Therapy (PCET) |
| Family Based, Internet-Based Cognitive Behavioral TherapyFamily-based cognitive behavioral therapy employing internet-delivered modules and videos | Behavioural | Family-Based Internet-Based CBT Group (iCBT) |
Primary outcome
Change in clinician-rated child anxiety severity (PARS) throughout the past week.
Time frame: baseline (before treatment or week 1), post-treatment (week 14), 1 month follow up (Week 18)
Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 30.
2 secondary outcomes
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) with Clinical Severity Ratings
Time frame: baseline (before treatment or week 1), post-treatment (week 14), 1 month follow up (Week 18)
Clinical Global Impression-Severity
Time frame: baseline (before treatment or Week 1), during treatment (on average 14 weeks), post-treatment (Week 14), 1 month follow up (Week 18)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 38788593Whiteside SPH, Biggs BK, Geske JR, Gloe LM, Reneson-Feeder ST, Cunningham M, Dammann JE, Brennan E, Ong ML, Olsen MW, Hofschulte DR. Parent-coached exposure therapy versus cognitive behavior therapy for childhood anxiety disorders. J Anxiety Disord. 2024 Jun;104:102877. doi: 10.1016/j.janxdis.2024.102877. Epub 2024 May 18.
- Background: PubMed 36908861Guzick AG, Schneider SC, Perozo Garcia AB, Kook M, Greenberg RL, Riddle D, McNeel M, Rodriguez-Barajas S, Yang M, Upshaw B, Storch EA. Development and pilot testing of internet-delivered, family-based cognitive behavioral therapy for anxiety and obsessive-compulsive disorders in autistic youth. J Obsessive Compuls Relat Disord. 2023 Apr;37:100789. doi: 10.1016/j.jocrd.2023.100789. Epub 2023 Feb 14.
- 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 Parent Coached Exposure Therapy and Family Based, Internet-Based Cognitive Behavioral Therapy in people with Obsessive Compulsive Disorder (OCD) and Anxiety Disorder of Childhood or Adolescence, 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 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in clinician-rated child anxiety severity (PARS) throughout the past week. (time frame: baseline (before treatment or week 1), post-treatment (week 14), 1 month follow up (Week 18)). 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 NCT07024758, which also lists 2 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 30 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.