Structured Games/Playgroup for Childhood Anxiety

No longer recruiting at 4 trial locations

Overseen By Sherry Chen

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: CNS medications

Disqualifiers: Head injury, PTSD, MDD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how structured games or a playgroup (known as Playgroup Therapy or Play-Based Intervention) might reduce anxiety in preschool-aged children. The aim is to determine if these activities can teach children to manage their emotions and behavior better, potentially reducing anxiety. Researchers will observe changes in behaviors and specific brain functions before and after the activities. Children who might be a good fit have clinical diagnoses of certain anxiety disorders, such as separation anxiety or social anxiety. As an unphased trial, this study offers a unique opportunity for children to potentially benefit from innovative therapeutic approaches.

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

Yes, you must stop taking medications that affect central nervous system functioning to participate in the trial.

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

Research has shown that structured games, like those used in Camp Kidpower, are well-received by preschoolers. Early findings suggest these brain-training games can reduce anxiety by enhancing children's ability to control their actions and feelings. Activities teach kids how to manage reactions and concentrate on goals.

Studies have also found that playgroups effectively reduce anxiety in young children. These play-based activities lower anxiety and related symptoms, offering a promising option for managing anxiety in preschoolers.

In summary, both structured games and playgroups have proven safe and helpful in reducing anxiety in young kids. No significant evidence of negative effects exists, making them a potentially effective choice for parents seeking to help their children manage anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Kidpower Playgroup and Structured Games because these approaches offer a fresh take on managing childhood anxiety. Unlike traditional treatments like cognitive-behavioral therapy (CBT) or medication, these interventions use play and structured activities to naturally engage children. The Playgroup and Structured Games camps aim to help kids develop social skills and coping mechanisms in a fun, supportive environment. This method is particularly appealing because it leverages the natural inclination of children to play, potentially leading to less resistance and more enthusiastic participation.

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

Research has shown that activities like play therapy can help reduce anxiety in young children. In this trial, participants will join one of two treatment arms. The Playgroup arm involves playgroup-based therapies, which studies have found improve social behaviors and lessen separation anxiety. The Structured Games arm, similar to those used in Camp Kidpower, focuses on helping children control their actions and emotions. Early results suggest these games can reduce anxiety by enhancing children's ability to think clearly and manage feelings. Both methods offer promising ways to help preschoolers with anxiety, though they may work differently for each child. ^{1 5 6 7 8}

Who Is on the Research Team?

Kate D Fitzgerald, M.D.

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for English-speaking children aged 4 to nearly 6 with anxiety disorders like separation, social, or generalized anxiety. Kids must not be in current therapy, have a history of serious mental conditions like autism or depression, head injuries, aggressive behavior causing harm, or be on certain medications.

Inclusion Criteria

Written informed consent by a parent/legal guardian and verbal assent from participant

Fluent in English

My child has been diagnosed with an anxiety or obsessive-compulsive disorder.

Exclusion Criteria

Sibling of a child who has participated or is currently participating in this protocol

History of head injury

History of Neurodevelopmental delay, autism spectrum disorder (ASD), or intellectual disability

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo training using either structured games or a playgroup to reduce anxiety

4-6 weeks

Pre-treatment and post-treatment assessments

Follow-up

Participants are monitored for changes in anxiety and effortful control after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Playgroup
• Structured games

Trial Overview

The Kidpower Camp aims to reduce anxiety in preschoolers through structured games or playgroup activities. It will measure changes in brain function and behaviors related to controlling emotions and actions before and after the program to see if it helps kids manage their anxiety better than regular playgroups.

How Is the Trial Designed?

Group I: Kidpower - Structured Games Experimental Treatment 1 Intervention

Structured Games Camp.

Group II: Kidpower - Playgroup Active Control 1 Intervention

Playgroup camp

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

University of Maryland

Collaborator

Trials

171

Recruited

325,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

Published Research Related to This Trial

The video game MindLight, designed with evidence-based therapeutic techniques, has shown significant improvements in anxiety symptoms in children, with effects lasting up to 6 months after intervention, based on results from two randomized controlled trials.

Changes in specific in-game behaviors that reflect therapeutic techniques were found to predict reductions in anxiety symptoms three months after the children stopped playing, suggesting that engagement with these techniques is crucial for the game's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Game Play Behaviours during an Applied Video Game for Anxiety Prevention Predict Successful Intervention Outcomes. Wols, A., Lichtwarck-Aschoff, A., Schoneveld, EA., et al.[2023]

A modified one-session treatment (OST) combining play therapy and exposure therapy was developed for preschoolers with specific phobias, showing promise in a preliminary case series of 4 children.

The approach, which includes engaging play therapy to build rapport and motivation, demonstrated feasibility and effectiveness in treating a 4-year-old girl with a severe phobia of dogs, suggesting it could be a valuable intervention for young children with anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy in a One-Session Treatment for a Preschooler With Specific Phobias. Kershaw, H., Farrell, LJ., Donovan, C., et al.[2020]

The study evaluated the effects of the Dramatic Therapeutic Play (DTP) technique on anxiety levels in 28 hospitalized school-age children, but found no significant difference in anxiety scores between the DTP group and the control group.

Despite the lack of significant results, the study suggests that further research with a larger sample size and varied hospitalization contexts is needed to better understand the potential benefits of DTP in reducing anxiety in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial. Silva, SGTD., Santos, MA., Floriano, CMF., et al.[2022]

In a study involving 94 parent-child pairs awaiting elective minor surgery, a group game intervention significantly reduced preoperative anxiety levels for both children and parents compared to a control group (P < .001).

The intervention included routine preoperative preparation followed by facilitated group play, demonstrating that engaging in play can effectively alleviate stress in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Group Game Intervention in Reducing Preoperative Anxiety Levels of Children and Parents: A Randomized Controlled Trial. Ünver, S., Güray, Ö., Aral, S.[2021]

A study involving 80 preschool children with autism spectrum disorder (ASD) found that interactive group sandplay significantly improved social withdrawal and overall behavior compared to individual sandplay after three months of treatment.

Both treatment methods were effective, but the interactive group sandplay led to greater improvements in sociability, emotional responses, and reductions in stereotypic behaviors, highlighting its potential as a more beneficial intervention for children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of interactive group sandplay versus individual sandplay in the treatment of preschool children with autism spectrum disorder]. Wang, YX., Lu, GB., Ge, P., et al.[2020]

A study involving 66 hospitalized children aged 1-12 years demonstrated that pop-it therapeutic play significantly reduced anxiety levels during inhalation therapy, with a p value of 0.000, indicating strong statistical significance.

The use of pop-it toys is recommended as an effective, non-pharmacological intervention to help manage anxiety in children undergoing medical procedures, making it a practical and easy-to-implement solution in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of pop-it therapeutic play on children's anxiety during inhalation therapy in children's wards. Bawaeda, O., Wanda, D., Aprillia, Z.[2023]

Therapeutic play significantly reduces anxiety levels in children aged 3-7 undergoing cast-removal procedures, with a mean difference of -20.1 compared to the control group.

Both parents and cast technicians reported higher satisfaction levels with the therapeutic play intervention, indicating its positive impact on the overall experience of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial. Wong, CL., Ip, WY., Kwok, BMC., et al.[2019]

Therapeutic play has been shown to reduce anxiety and improve cooperative behavior in children undergoing invasive procedures, based on a systematic review of 12 studies conducted across various countries.

However, the overall evidence is considered questionable due to methodological issues in the studies, such as lack of randomization and blinding, indicating a need for more rigorously designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic play to prepare children for invasive procedures: a systematic review. Silva, RD., Austregésilo, SC., Ithamar, L., et al.[2022]

Children hospitalized for acute illness who engaged in therapeutic play showed a significant reduction in their self-reported fears about being in the hospital, compared to those in other treatment groups.

While parents rated their children's anxiety levels as lower after treatment, there was no significant difference in parent ratings between the different play conditions, suggesting that therapeutic play may primarily benefit children's self-perception rather than parental observations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The psychosocial impact of play on hospitalized children. Rae, WA., Worchel, FF., Upchurch, J., et al.[2019]

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