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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone-based treatment designed to help parents influence their children's anxiety by changing how they interpret uncertain situations. The focus is on reducing anxiety-promoting behaviors that parents might unintentionally model for their kids. Parents who often feel anxious, own a smartphone, and have a child aged 7-12 with similar concerns might be a good fit. The goal is to improve mental health outcomes by teaching parents to handle ambiguity in a less threatening way, benefiting both them and their children. As an unphased trial, this study offers a unique opportunity for parents to contribute to innovative research that could enhance family mental health.

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 prior data suggests that this protocol is safe for children?

Research shows that HabitWorks, a smartphone app, may assist parents of anxious children. Early studies found HabitWorks easy to use and liked by users. These findings suggest the app is well-received, with no major safety issues reported.

The app helps parents view uncertain situations in a less frightening way through quick exercises that aim to change automatic reactions. HabitWorks is designed to be simple and is available entirely on a smartphone, making it easily accessible for most parents.

While these early studies are promising, they mainly focus on the app's ease of use and acceptability, rather than detailed safety information. More research is needed to fully understand any possible side effects. However, as a non-invasive digital tool, HabitWorks is expected to have fewer risks compared to direct medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HabitWorks for treating anxiety in children because it offers a fresh approach compared to traditional methods like medication or standard talk therapy. Unlike most treatments that often require in-person sessions, HabitWorks uses a smartphone app, making it accessible and convenient. The app's unique feature is the Word Sentence Association Paradigm (WSAP), which helps kids become aware of their cognitive biases and automatically shift their responses through quick and repetitive practice. This digital, interactive method could make therapy more engaging and effective for young users, potentially leading to faster improvements in anxiety symptoms.

What evidence suggests that this trial's treatments could be effective for anxiety in children?

Research suggests that HabitWorks, which participants in this trial may use, aims to change how children interpret situations and might help treat anxiety in kids. A small initial study with parents of anxious children found that HabitWorks is a practical and acceptable low-effort approach. However, a review of similar programs has shown they generally have a small and not very significant impact on reducing anxiety and depression. Another study found that these types of programs did not significantly change social anxiety or how children interpret situations. These findings indicate that while HabitWorks shows some potential, more research is needed to confirm its effectiveness in treating anxiety in children. ^{1 6 7 8 9}

Who Is on the Research Team?

Courtney Beard, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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 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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10933640/

Cognitive bias modification of interpretations for anxiety ... This meta‐analysis found CBM‐I had a small and non‐significant unadjusted effect on anxiety and depressive symptoms using validated measures.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0887618516303498

Cognitive bias modification of interpretation in children with ... Effects on interpretation bias and social anxiety were assessed. The adapted CBM-I training was not associated with significant changes in benign or negative ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/14/4/e078652

study protocol of a randomised controlled trial This study aims to evaluate the effectiveness and acceptability of an online CBM-I intervention (Mindmaster) for children with symptom scores of anxiety or ...

4. acamh.onlinelibrary.wiley.com acamh.onlinelibrary.wiley.com/doi/abs/10.1002/jcv2.12207

Cognitive bias modification of interpretations for anxiety and ... This meta-analysis aimed to establish the effects of CBM-I for children and adolescents on both anxiety and depression using psychometrically ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9731147/

A Pilot Feasibility Open Trial of an Interpretation Bias ... In this pilot feasibility study in parents of anxious youth, HabitWorks was a feasible and acceptable low-intensity intervention. These preliminary results ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722921001292

A Pilot Feasibility Open Trial of an Interpretation Bias ... The current pilot study tested the feasibility and acceptability of an interpretation bias intervention delivered by a smartphone app, called HabitWorks, in ...

7. withpower.com withpower.com/trial/phase-anxiety-disorders-8-2023-d0ab4

Cognitive Behavioral Therapy for 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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01178385

Cognitive-Behavioral Treatment for Anxiety Disorders in ... Accordingly, we are proposing a randomized controlled trial to examine the effectiveness of CBT relative to treatment as usual (TAU) in 46 youth ages 7-11 with ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3091167/

Cognitive Behavioral Therapy for Anxiety Disorders in Youth Cognitive behavioral therapies (CBTs) have been shown to be efficacious for the treatment of anxiety disorders in children and adolescents.