Structured Games/Playgroup for Childhood Anxiety

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

158 Participants Needed

Trial Summary

What is the purpose of this trial?

Clinically significant anxiety affects 20% of preschoolers and can become chronic, leading to depression, substance abuse, school-drop out and even suicide. To reduce anxiety and prevent its sequelae, clinically affected children must be effectively treated early. Available interventions for clinically anxious preschoolers are effective for some, but not all children, with as many as 50% of 4-7 year olds continuing to meet criteria for an anxiety disorder after treatment. This trial aims to help learn how Camp Kidpower, trainings using either structured games or a playgroup, may lower anxiety in preschool age children. Playing these games and learning that kids can do it, can teach kids how to keep going when they are feeling anxious. To find out if Kidpower works by helping kids stay in charge of their behaviors and emotions, the study will look at parts of the brain as well as behaviors related to effortful control and fear, before and after training. The study hypothesizes that Kidpower will produce greater increases in Error-related negativity (ERN), Interchannel Phase Synchrony (ICPS) and effortful control (EC) behaviors than in the Playgroup control.

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.

What data supports the idea that Structured Games/Playgroup for Childhood Anxiety is an effective treatment?

The available research shows that structured games and play-based interventions can effectively reduce anxiety in children. For example, a study on a video game called MindLight, which uses therapeutic techniques, found that children who played the game showed improvements in anxiety symptoms that lasted for three months after they stopped playing. Another study demonstrated that group game interventions significantly decreased anxiety levels in children and their parents before surgery. These findings suggest that structured games and play-based interventions can be a helpful treatment for childhood anxiety. ^{1 2 3 4 5}

What safety data exists for structured games or playgroup therapy for childhood anxiety?

The research provided does not directly address the safety data for structured games or playgroup therapy specifically for childhood anxiety. However, related studies on therapeutic play and group interventions suggest these methods are generally feasible, acceptable, and effective in reducing anxiety in children. For example, a study on a one-session treatment incorporating play therapy for preschoolers with specific phobias showed preliminary evidence of feasibility and effectiveness. Another study on group game interventions demonstrated reduced anxiety levels in children and parents before surgery. These findings imply that structured play interventions are likely safe and beneficial for managing anxiety in children. ^{3 4 6 7 8}

Is Playgroup Therapy a promising treatment for childhood anxiety?

Yes, Playgroup Therapy is promising for childhood anxiety. It uses structured games and play to help reduce anxiety, similar to other successful game-based interventions that have shown positive results in reducing anxiety in children. ^{1 2 3 8 9}

Research Team

Kate D Fitzgerald, M.D.

Principal Investigator

Columbia University

Eligibility Criteria

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Influence of Therapeutic Play on the anxiety of hospitalized school-age children: Clinical trial. [2022]

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

In-Game Play Behaviours during an Applied Video Game for Anxiety Prevention Predict Successful Intervention Outcomes. [2023]

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

Effectiveness of a Group Game Intervention in Reducing Preoperative Anxiety Levels of Children and Parents: A Randomized Controlled Trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial. [2019]

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

The psychosocial impact of play on hospitalized children. [2019]

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

Cognitive Behavioral Therapy in a One-Session Treatment for a Preschooler With Specific Phobias. [2020]

7. China pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of interactive group sandplay versus individual sandplay in the treatment of preschool children with autism spectrum disorder]. [2020]

8. Brazil pubmed.ncbi.nlm.nih.gov

Therapeutic play to prepare children for invasive procedures: a systematic review. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Effectiveness of pop-it therapeutic play on children's anxiety during inhalation therapy in children's wards. [2023]