Family-Based Behavioral Therapy for Childhood Anxiety and OCD

Overseen By Eric Storch, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Antidepressants, Antipsychotics, Benzodiazepines, ADHD medications

Disqualifiers: Bipolar, Psychotic, Conduct, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12-14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of family-based treatments delivered online for children with anxiety or obsessive-compulsive disorder (OCD). It compares these treatments to a relaxation and mentorship program that includes breathing exercises with a therapist. The goal is to determine which method is most effective and how they benefit children. Families with children aged 7 to 13 who exhibit noticeable anxiety or OCD symptoms may be suitable participants, especially if the child can engage in therapy and a parent can attend the sessions. As an unphased trial, this study provides families with an opportunity to explore innovative treatment options that could significantly enhance their child's well-being.

Do I need to stop my current medications to join the trial?

You don't need to stop your current medications, but they must be stable for a certain period before joining the trial. If you're on an antidepressant, it should be stable for 12 weeks, and for other medications like antipsychotics or ADHD meds, it should be stable for 6 weeks. Any changes to your medication should have been made at least 4 weeks before joining.

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

Research has shown that family-based, online cognitive behavioral therapy (iCBT) for anxiety and OCD in young people can significantly reduce anxiety symptoms. Past participants found this type of therapy easy to handle.

For the Relaxation and Mentorship Training (RMT), family-based therapy that includes relaxation exercises is generally safe for children with anxiety. However, it may not reduce symptoms as effectively as more intensive CBT methods.

Overall, both treatment approaches are considered safe for children. They use therapy and relaxation techniques, which are common and generally accepted for treating childhood anxiety and OCD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatment approaches for childhood anxiety and OCD because they offer family-centered, accessible solutions that differ from traditional therapies like individual CBT or medication. The Parent Training Bibliotherapy (SPACE) method empowers parents with structured guidance and literature, encouraging them to independently manage their child's anxiety with professional support. The Family-Based Internet-Based CBT (iCBT) introduces a novel, digital approach where parents lead their children through exposure tasks, an essential CBT component, with therapist support via video and email. Lastly, the Relaxation and Mentorship arm emphasizes stress-reduction techniques, like deep breathing and muscle relaxation, in a family-inclusive setting, which can foster a supportive environment for the child. These approaches aim to involve the family more deeply in the therapeutic process, potentially enhancing efficacy and accessibility.

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

Research has shown that family-based cognitive behavioral therapy (CBT), one of the treatments in this trial, effectively reduces anxiety and OCD symptoms in children. Studies indicate that online family-based CBT, particularly with therapist support, lowers anxiety disorders in children. Additionally, family-centered approaches tailored to a child's needs have improved OCD symptoms.

In this trial, another group of participants will receive relaxation and mentorship training (RMT). Studies suggest that RMT is less effective than exposure-focused CBT, a therapy that gradually introduces children to their fears. While RMT can help reduce stress through activities like breathing exercises, it generally does not reduce anxiety as much as other CBT methods. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for children aged 7-13 in Texas with significant anxiety or OCD, as indicated by specific test scores. They must have the ability to engage in CBT and live with a participating parent at least half the time. Children on stable medication may qualify, but those starting new treatments recently or changing dosages are excluded.

Inclusion Criteria

The participating parent/guardian lives with their child at least 50% of the time per self-report

The child is appropriate for anxiety-focused treatment as diagnosed using the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)

One parent/guardian is able and willing to participate in assessment and treatment

Exclusion Criteria

My child currently has severe thoughts of harming themselves or others, needing medical help.

My child is currently being treated for anxiety.

My mental health medications have been stable for the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three interventions: Relaxation and Mentorship Training, SPACE, or iCBT over 12-14 weeks

12-14 weeks

4-6 video calls (30-45 minutes each), additional email support

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Family Based
• Relaxation and Mentorship

Trial Overview

The study compares family-based and internet-delivered cognitive behavioral therapy (CBT) against Relaxation and Mentorship Training (RMT). It aims to determine which method is more effective for treating anxiety and OCD in youth through telehealth services.

How Is the Trial Designed?

Group I: Parent Training Bibliotherapy (SPACE) Experimental Treatment 1 Intervention

One third of participants will be randomized to the SPACE group. Families will receive 4 45-minute supportive video calls with a therapist over the course of 12-14 weeks. Participating families will receive a copy of the book 'Breaking Free of Child Anxiety and OCD' to use at home and in session with the therapist. During each of the video-conferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.

Group II: Family-Based Internet-Based CBT Group (iCBT) Experimental Treatment 1 Intervention

One third 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 (6 30-minute supportive videoconferencing via Zoom, 6 emails on alternating weeks). 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 III: Active Comparator Active Control 1 Intervention

One third of participants will be randomized to receive a Relaxation and Mentorship. This involves attending 4 45-minute sessions with a therapist over the course of 12-14 weeks. Topics covered include breathing slowly and deeply, coloring activities, and releasing muscle tension to reduce stress levels.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

A study involving 20 families with young children diagnosed with OCD found that both Cognitive-Behavioral Family-Based Treatment (CBFT) and Parent Training (PT) led to clinical improvements in obsessive-compulsive symptoms, indicating that parent-only interventions can be effective.

CBFT was more effective than PT in reducing externalizing problems, suggesting that while parent-only interventions are feasible, having the child present during treatment may provide additional benefits for certain symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary study of cognitive-behavioral family-based treatment versus parent training for young children with obsessive-compulsive disorder. Rosa-Alcázar, AI., Iniesta-Sepúlveda, M., Storch, EA., et al.[2022]

Family-based interventions are effective in treating pediatric obsessive-compulsive disorder (OCD) by improving how family members manage symptoms and interact with each other.

The article emphasizes the importance of understanding family dynamics and provides practical guidance on implementing family-based cognitive-behavioral therapy, supported by empirical evidence and case examples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-Based Treatment of Pediatric Obsessive-Compulsive Disorder: Clinical Considerations and Application. Anderson, LM., Freeman, JB., Franklin, ME., et al.[2018]

This study is a randomized clinical trial comparing family-based cognitive behavioral therapy (FCBT) to family-based psychoeducation and relaxation training (FPRT) in children and adolescents aged 8-17 with obsessive-compulsive disorder (OCD), aiming to include at least 128 participants to ensure robust results.

The trial is designed to minimize bias and enhance the reliability of findings by using blinding for assessors and randomizing therapists to deliver both interventions, allowing for a clearer understanding of the specific benefits and harms of FCBT compared to FPRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial). Pagsberg, AK., Uhre, C., Uhre, V., et al.[2022]

In a study involving 269 children and adolescents aged 7-17 with OCD, 72.6% of participants who completed 14 weeks of manualized exposure-based CBT showed significant treatment response, as indicated by a CY-BOCS score of ≤15.

The treatment resulted in a mean symptom reduction of 52.9% and a high effect size of 1.58, demonstrating that this CBT approach is both effective and feasible for use in community mental health clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive behavior treatment for pediatric obsessive-compulsive disorder: acute outcomes from the Nordic Long-term OCD Treatment Study (NordLOTS). Torp, NC., Dahl, K., Skarphedinsson, G., et al.[2022]

Exposure-based cognitive-behavioral therapy (CBT) is effective for treating anxiety disorders and OCD in youth, but many still experience symptoms after treatment, indicating a need for improvement in therapeutic approaches.

Addressing specific parental behaviors, such as family accommodation and anxious behaviors, can enhance the effectiveness of CBT, suggesting that involving parents in treatment may lead to better outcomes for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming barriers in cognitive-behavioral therapy for youth anxiety and obsessive-compulsive disorder: Addressing parent behaviors. Chiappini, EA., Parrish, C., Reynolds, E., et al.[2021]

Cognitive-behavioral family treatment for children with OCD (ages 5.2-7.9) showed clinical improvements across all treatment conditions, indicating its overall efficacy in reducing OCD symptoms.

Involving more family members in the treatment, particularly the child, led to better outcomes, highlighting the importance of family dynamics in managing OCD effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family involvement and treatment for young children with Obsessive-Compulsive Disorder: Randomized control study. Rosa-Alcázar, Á., Rosa-Alcázar, AI., Olivares-Olivares, PJ., et al.[2022]

Family-based cognitive-behavioral therapy (CBT) was found to be effective for young children aged 5 to 8 with obsessive-compulsive disorder (OCD), showing a moderate treatment effect in the intent-to-treat sample and a large effect in those who completed the treatment.

In the study of 42 children, 50% of those receiving CBT achieved remission compared to only 20% in the family-based relaxation treatment (RT) group, highlighting CBT's superior efficacy in addressing OCD symptoms in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early childhood OCD: preliminary findings from a family-based cognitive-behavioral approach. Freeman, JB., Garcia, AM., Coyne, L., et al.[2022]

A case study of a 7-year-old boy with obsessive-compulsive disorder (OCD) demonstrated significant improvement in symptoms and functioning through family-based cognitive-behavioral therapy (CBT) using exposure with response prevention (ERP).

The treatment emphasized family involvement, understanding the relationship between obsessions and compulsions, and creating conditions for habituation, highlighting the effectiveness of these strategies in adapting ERP for young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Family-Based Exposure With Response Prevention to Treat Obsessive-Compulsive Disorder in Young Children: A Case Study. Herren, J., Freeman, J., Garcia, A.[2018]

A family and patient-oriented empowerment program significantly reduced depression, anxiety, and stress in 50 OCD patients over eight training sessions, while the control group showed no significant changes in these areas.

The program also led to a notable decrease in caregiver burden, highlighting the benefits of involving both patients and their caregivers in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Family and Patient Centered Empowerment Program on Depression, Anxiety and Stress in Patients with Obsessive-Compulsive Disorder and Their Caregivers' Burden. Heidari, T., Mousavi, SM., Mousavinasab, SN., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4511269/

Family-Based Treatment of Early Childhood OCD

A comprehensive, family based CBT program was superior to a relaxation program with similar format in reducing OCD symptoms and functional impairment in young ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0887618523001408

Treating child anxiety using family-based internet delivered ...

Online family-based cognitive behaviour therapy reduces child anxiety disorders. •. Therapist support during online child anxiety programs may be important for ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07024758

Comparative Effectiveness of Internet-based Versus Parent ...

This research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/18356758/

Early childhood OCD: preliminary findings from a family-based ...

Results indicate that children with early-onset OCD benefit from a treatment approach tailored to their developmental needs and family context.

5.

link.springer.com

link.springer.com/article/10.1007/s00787-025-02797-4

Family-based cognitive behavioral therapy versus ...

Few randomized clinical trials (RCTs) have compared cognitive behavioral therapy (CBT) versus active control interventions for pediatric ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3205429/

Controlled Comparison of Family Cognitive Behavioral ...

FCBT is effective for reducing OCD severity and impairment. Importantly, treatment also reduced parent-reported involvement in symptoms with reduced ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0005796715001060

Comparing outcomes for children with different anxiety ...

The purpose of this study was to compare treatment outcomes following a group family-based cognitive behavioural therapy for children with different anxiety ...