Cognitive Behavioral Therapy for Anxiety in Children

Overseen By Courtney Beard, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Mclean Hospital

Disqualifiers: Intellectual disability, Autism, Severe suicidal ideation, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 4 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

Approximately 30% of children will experience an anxiety disorder, making anxiety the most common mental health problem among children in the United States. However, few children receive treatment and even our most effective anxiety treatments leave up to half of children in need of additional intervention. Despite the well-established role of parent anxiety in transmitting and maintaining child anxiety, the lack of data on specific parent mechanisms underlying the intergenerational transmission of anxiety is a critical barrier to informing novel targets of personalized treatments. Consistent with NIMH's Strategic Plan, Objective 2.2 to understand risk factors and behavioral indicators of mental illness across the lifespan and to identify novel intervention targets based on knowledge of psychological mechanisms, the current study focuses on interpretation bias, the tendency to perceive threat in ambiguous situations. The overall objective of this project is to empirically test a theoretical model of the intergenerational transmission of anxiety focused on parent interpretation bias as a root cause. Our specific aims are to test theorized effects of parent interpretation bias on (1) parent behavior and (2) child interpretation bias and (3) evaluate potential moderators to refine theories of intergenerational transmission of anxiety and inform future personalized interventions. Our central hypothesis is that parent interpretation bias influences child interpretation bias through its effects on maladaptive, anxiety-promoting parenting behaviors, such as accommodation and modeling of avoidant coping. To test this hypothesis, we will randomize 300 parents of children ages 7-12 to complete four weeks of a smartphone delivered interpretation bias manipulation vs. a self-assessment smartphone app condition. The interpretation bias intervention teaches parents to interpret ambiguous situations in a non-threatening manner via quick, repeated practice and corrective feedback. Before and after completing their randomly assigned condition, parent-child dyads will complete self-report and behavioral tasks designed to elicit anxiety-promoting behaviors from parents depending upon their interpretation of the ambiguous situation (speech and puzzle tasks). Parents will also complete Ecological Momentary Assessment (EMA) of parenting behaviors to capture the time course of effects. Finally, we will examine downstream effects of the interpretation manipulation on child interpretation bias at pre- and post- visits. We will test moderators (e.g., parent anxiety and gender) to refine theories of intergenerational transmission of anxiety and inform future personalized interventions. The long-term goal of this work is to inform personalized, mechanism-focused interventions to improve mental health outcomes for anxious children and their parents. Future studies will translate knowledge gained from this project into a scalable treatment that can be implemented entirely remotely via smartphone thereby increasing access to care

Will I have to stop taking my current medications?

The trial requires that if you are receiving treatment, you must be stable on your medications or therapy for at least 8 weeks before participating. This means you can continue your current medications as long as they have been stable for that period.

What data supports the effectiveness of the treatment HabitWorks, Lynparza, Self-Assessment, Self-Assessment Smartphone App for anxiety in children?

Research shows that cognitive behavioral therapy (CBT), which is a part of the treatment, is effective for reducing anxiety in children. Studies have found that both computer-assisted and internet-based CBT can help children manage anxiety, suggesting that similar approaches like HabitWorks and Self-Assessment Smartphone App might also be beneficial. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for treating anxiety in children?

Research shows that Cognitive Behavioral Therapy (CBT) is generally safe for treating anxiety in children, with no significant safety concerns reported in studies. It is a well-established treatment method with a focus on helping children manage their anxiety through structured sessions. ^{6 7 8 9 10}

Research Team

Courtney Beard, PhD

Principal Investigator

Mclean Hospital

Eligibility Criteria

This trial is for parents with mild anxiety (GAD-7 score > 5) who have a child aged 7-12. They must own a smartphone, have some bias in interpreting ambiguous situations, and share custody of their child. Participants should not have severe psychiatric symptoms, intellectual disabilities or autism in the family, or severe suicidal thoughts.

Inclusion Criteria

You have an iPhone or an Android smartphone.

You don't have any mental health symptoms that would make it hard for you to understand and agree to join the study or finish the research tasks.

You don't have strong thoughts about hurting yourself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Parents complete four weeks of a smartphone-delivered interpretation bias manipulation or a self-assessment app condition

4 weeks

12 exercises (remote)

Follow-up

Participants are monitored for changes in parent and child interpretation bias and parent behavior

2 weeks

Treatment Details

Interventions

• HabitWorks
• Self-Assessment

Trial Overview The study tests if changing how anxious parents interpret unclear situations can affect their parenting and reduce anxiety in children. Parents are randomly assigned to use either HabitWorks app to learn non-threatening interpretations or a self-assessment app for four weeks.

Participant Groups

Group I: Interpretation bias manipulation Experimental Treatment 2 Interventions

The primary component of the interpretation bias manipulation is the Word Sentence Association Paradigm (WSAP) delivered by the HabitWorks smartphone app. Users complete 50 trials in each exercise (approximately 5 min) and are prompted to complete 3 exercises per week (12 total over 4 weeks). The WSAP incorporates repetitive and quick practice, increasing individuals' awareness of their cognitive biases and shifting of their automatic responses.

Group II: Self-Assessment Placebo Group 1 Intervention

Parents will complete the same repeated assessments, including EMA of parent behavior and weekly symptom surveys, but they will not complete the WSAP.

HabitWorks is already approved in European Union, United States for the following indications:

Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer
• Endometrial cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Findings from Research

Camp Cope-A-Lot (CCAL), a computer-assisted cognitive behavioral therapy for anxiety, was found to be effective, with 81% of participants no longer meeting criteria for their anxiety diagnosis after treatment, similar to individual CBT results.

Both CCAL and individual CBT were rated as more acceptable and satisfying by children and parents compared to a control group receiving computer-assisted education, indicating strong potential for using technology in treating youth anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted cognitive behavioral therapy for child anxiety: results of a randomized clinical trial. Khanna, MS., Kendall, PC.[2022]

This study will evaluate the effectiveness of a group-based acceptance and commitment therapy (ACT) program for 150 young people (90 children and 60 adolescents) diagnosed with anxiety disorders, making it the largest trial of ACT in this demographic to date.

Participants will be compared against a cognitive behavior therapy (CBT) group and a waitlist control, allowing for a comprehensive analysis of both ACT and CBT in treating anxiety, with assessments conducted immediately post-therapy and three months later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for anxious children and adolescents: study protocol for a randomized controlled trial. Swain, J., Hancock, K., Dixon, A., et al.[2021]

In a study involving 182 youth with anxiety disorders, higher therapist adherence to CBT protocols was linked to better treatment outcomes, highlighting the importance of following established guidelines.

Interestingly, while formal CBT training improved outcomes, more years of clinical experience and higher competence ratings were sometimes associated with worse outcomes, suggesting that experience alone does not guarantee effectiveness in treating youth anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do clinical experience, formal cognitive behavioural therapy training, adherence, and competence predict outcome in cognitive behavioural therapy for anxiety disorders in youth? Fauskanger Bjaastad, J., Henningsen Wergeland, GJ., Mowatt Haugland, BS., et al.[2019]

In a study involving 73 children aged 7-12 with anxiety disorders, those who received Internet-based cognitive-behavioral therapy (CBT) showed significant reductions in anxiety symptoms compared to those on a wait-list.

At a 6-month follow-up, 75% of children who underwent the Internet-based CBT were free of their primary anxiety diagnosis, indicating the long-term efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of an internet-based cognitive-behavioral therapy intervention for child anxiety disorders. March, S., Spence, SH., Donovan, CL.[2022]

In a study involving 133 clinically anxious children aged 8-12, 74% were free of any anxiety disorder after a stepped care approach using cognitive behavior therapy (CBT), which included up to 10 sessions of child-focused treatment and additional phases if needed.

The results showed significant improvements in anxiety and depression symptoms for both children and parents throughout all treatment phases, highlighting that more intensive treatment can lead to better outcomes for those who initially did not respond to the first phase of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped care cognitive behavioural therapy for children with anxiety disorders: a new treatment approach. van der Leeden, AJ., van Widenfelt, BM., van der Leeden, R., et al.[2018]

In a study of 279 youth aged 7-17 undergoing cognitive behavioral therapy (CBT) for anxiety disorders, living with both parents and having fewer externalizing disorders were strong predictors of better adherence to treatment.

Higher compliance ratings from therapists were linked to better treatment outcomes, such as reduced anxiety severity and improved functioning, emphasizing the importance of active participation in therapy activities beyond just attending sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child and Adolescent Adherence With Cognitive Behavioral Therapy for Anxiety: Predictors and Associations With Outcomes. Lee, P., Zehgeer, A., Ginsburg, GS., et al.[2022]

A study of 86 young adults, who had previously undergone 16 weeks of cognitive-behavioral therapy for anxiety disorders, showed that many maintained significant improvements in their anxiety levels an average of 7.4 years later.

Participants who responded positively to the anxiety treatment reported lower levels of substance use and related problems compared to those with less favorable outcomes, highlighting the long-term benefits of early intervention for childhood anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child anxiety treatment: outcomes in adolescence and impact on substance use and depression at 7.4-year follow-up. Kendall, PC., Safford, S., Flannery-Schroeder, E., et al.[2022]

In a study of 128 children and adolescents with anxiety disorders treated with fluvoxamine, no significant demographic or illness characteristics were found to moderate treatment efficacy, except for lower baseline depression scores reported by parents, which were linked to better outcomes.

Social phobia and greater severity of illness were associated with less improvement in treatment, highlighting the need for special attention to these factors in future studies of anxiety treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Searching for moderators and mediators of pharmacological treatment effects in children and adolescents with anxiety disorders. Walkup, JT., Labellarte, MJ., Riddle, MA., et al.[2022]

Cognitive-behavioral therapy (CBT) has been shown to be effective in treating pediatric anxiety disorders, while no controlled studies have proven the efficacy of psychopharmacological treatments in children and adolescents, except for obsessive-compulsive disorder.

The review highlights the need for more methodologically sound psychopharmacotherapy trials, as several are currently underway, to better understand and treat pediatric anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of anxiety disorders in children and adolescents. Labellarte, MJ., Ginsburg, GS., Walkup, JT., et al.[2022]

In a study of 281 young people aged 6-16 with anxiety disorders, face-to-face treatment resulted in a higher remission rate (66%) compared to low-intensity treatment (49%), indicating that traditional therapy is more effective for youth anxiety.

While face-to-face therapy required significantly more therapist time (897 minutes) and cost ($A735) compared to low-intensity methods (175 minutes), the small difference in treatment outcomes suggests that low-intensity options could be a cost-effective alternative for some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity treatment for clinically anxious youth: a randomised controlled comparison against face-to-face intervention. Rapee, RM., Lyneham, HJ., Wuthrich, V., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Computer-assisted cognitive behavioral therapy for child anxiety: results of a randomized clinical trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for anxious children and adolescents: study protocol for a randomized controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Do clinical experience, formal cognitive behavioural therapy training, adherence, and competence predict outcome in cognitive behavioural therapy for anxiety disorders in youth? [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The efficacy of an internet-based cognitive-behavioral therapy intervention for child anxiety disorders. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Stepped care cognitive behavioural therapy for children with anxiety disorders: a new treatment approach. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Child and Adolescent Adherence With Cognitive Behavioral Therapy for Anxiety: Predictors and Associations With Outcomes. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Child anxiety treatment: outcomes in adolescence and impact on substance use and depression at 7.4-year follow-up. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Searching for moderators and mediators of pharmacological treatment effects in children and adolescents with anxiety disorders. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The treatment of anxiety disorders in children and adolescents. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Low intensity treatment for clinically anxious youth: a randomised controlled comparison against face-to-face intervention. [2021]