Cognitive Behavioral Therapy for Childhood Anxiety and OCD

(ASTRO Trial)

Overseen By Eric Storch, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Antidepressants, Stimulants, Benzodiazepines, Antipsychotics

Disqualifiers: Psychotic disorder, Conduct disorder, Suicidality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 14 weeks

174 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of cognitive behavioral therapy (CBT) for treating anxiety and OCD in children. One group will receive internet-based CBT, with parents guiding their children through online therapy activities. The other group will participate in parent-coached exposure therapy, involving sessions where parents and children work with a therapist to confront fears directly. Children aged 7 to 17 with significant anxiety or OCD symptoms, along with a parent willing to participate, are suitable candidates. Conducted in Texas, the trial offers a unique opportunity for families who might face barriers to accessing traditional therapy. As an unphased trial, it provides families access to innovative therapy approaches that might not be available elsewhere.

Do I have to stop taking my current medications to join the trial?

You may need to pause ongoing therapy focused on anxiety or OCD to join the trial. If you've started new antidepressants within 12 weeks (or 4 weeks for stimulants/benzodiazepines/antipsychotics) or changed the dosage of psychotropic medications within 4 weeks (or 2 weeks for stimulants/benzodiazepines/antipsychotics), you might not be eligible.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Internet-Based Cognitive Behavioral Therapy (iCBT) and Parent Coached Exposure Therapy (PCET) are well-received for treating anxiety and OCD in children. Studies have found that 89% of young patients are satisfied with iCBT, indicating it is generally safe and comfortable for children.

Research supports the effectiveness and safety of PCET. This method involves parents in the therapy, which has been shown to improve results. Studies indicate that PCET effectively increases the involvement of both parents and children without major safety concerns.

Overall, both treatment methods are considered safe for children, with research supporting their use in reducing anxiety symptoms. The reviewed studies reported no significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for childhood anxiety and OCD because they offer innovative, family-focused approaches that leverage technology and direct parental involvement. Unlike traditional in-person therapy sessions, the Internet-Based Cognitive Behavioral Therapy (iCBT) allows families to access treatment materials online, providing flexibility and empowering parents to guide their children through exposure exercises with the support of a therapist. Parent Coached Exposure Therapy (PCET) stands out by integrating parents directly into the therapy process during in-person sessions, emphasizing the development of exposure hierarchies and hands-on involvement in tackling anxiety. These methods aim to make therapy more accessible and effective by actively involving the family, potentially leading to better outcomes for children.

What evidence suggests that this trial's treatments could be effective for childhood anxiety and OCD?

This trial will compare two treatments for childhood anxiety and OCD: Internet-Based Cognitive Behavioral Therapy (iCBT) and Parent Coached Exposure Therapy (PCET). Research has shown that iCBT effectively reduces anxiety and OCD symptoms in children and teens. Studies indicate that users receive it well and experience significant symptom decreases, similar to traditional in-person therapy. In contrast, PCET is a newer method that teaches both parents and children how to manage anxiety. Research has found that PCET can improve anxiety symptoms more quickly than traditional CBT methods. Both iCBT and PCET have shown positive results in managing anxiety and OCD in young people, but more research is needed to determine which is more effective. Participants in this trial will be randomized to receive either iCBT or PCET. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children and adolescents who struggle with various anxiety disorders or OCD. It's designed to help those who find it hard to access traditional therapy due to costs, travel issues, or a lack of local therapists.

Inclusion Criteria

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)

Exclusion Criteria

My child is currently in therapy for anxiety or OCD but can pause it to join the study.

My child cannot talk on their own.

The child requires a higher level of care than can be provided through the study (e.g., significant, current suicidal ideation)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Internet-based CBT (iCBT) or Parent-Coached Exposure Therapy (PCET) for anxiety and OCD

14 weeks

7 visits (virtual) for iCBT, 12 visits (in-person) for PCET

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Internet-Based Cognitive Behavioral Therapy
• Parent Coached Exposure Therapy

Trial Overview The study compares two treatments: internet-based CBT (iCBT) where kids learn coping skills online, and parent-coached exposure therapy (PCET), where parents are taught how to guide their kids through anxiety-provoking situations.

How Is the Trial Designed?

Group I: Family-Based Internet-Based CBT Group (iCBT) Active Control 1 Intervention

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.

Group II: Parent Coached Exposure Therapy (PCET) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8386338/

Internet-based cognitive behavioral therapy in children and ... Outcomes showed high acceptance and satisfaction on the part of patients with online treatment (89%) and that face-to-face therapy was not ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07024758?draw=2&rank=1

Comparative Effectiveness of Internet-based Versus Parent ... 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.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214782924000319

Effectiveness of internet-delivered cognitive behavioural ... This study aimed to explore the acceptability, feasibility, and effectiveness of ICBT for children and adolescents with anxiety disorders and obsessive- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10248767/

Efficacy and Cost-Effectiveness Analysis of Internet-Based ... The effectiveness of ICBT in the treatment of depression [10-12], anxiety [13], pediatric anxiety [14], and OCD [15] has been proven. In ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.989550/full

Internet-based cognitive behavioral therapy in children and ... Conclusion: In our study, OCD symptoms decreased significantly and remission rate was high after internet-based CBT. Those effects were comparable to those ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0890856725000656

Internet-Based Cognitive–Behavioral Therapy Intervention ... Previous ICBT studies have generally shown a reduction in clinician-rated anxiety symptoms, whereas results for child- and parent-rated anxiety ...

7. mental.jmir.org mental.jmir.org/2016/3/e29/

Online Obsessive-Compulsive Disorder Treatment Preliminary results support the effectiveness of therapist-assisted iCBT for young people with OCD; however, no previous studies have examined ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/16506073.2025.2522995?src=

Internet-based cognitive behavioral therapy (ICBT) for ... The aim of this study was to test the feasibility of delivering ICBT for adolescents with anxiety disorders with different types of written therapist support ...