Effect of Cognitive Behavioral Play Intervention and Epilepsy

Not Applicable

Recruiting

• Conditions: Epilepsy; Epilepsy in Children

• Registration Number: NCT06813612
• Lead Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation

Brief Summary

The goal of this clinical trial is to assess the effectiveness of Cognitive Behavioral Play Therapy interventions in patients with epilepsy.

Children with epilepsy will be randomly assigned to one of two intervention conditions: the experimental group will receive cognitive-behavioral play intervention, while the control group will engage in free play. Assessments will be done at the start (T0) and end (T1) of the intervention, measuring behaviors, coping strategies, positive thinking, problem-solving, and quality of life.

Detailed Description

Cognitive-Behavioral Play Therapy (CBPT) adapts Cognitive-Behavioral Therapy techniques into a play-based intervention for preschool and school-age children, especially for those facing challenges like hospitalization or chronic illnesses. Studies show that play has therapeutic value, helping children understand critical events, reduce anxiety, and cope with illness. This research aims to explore how CBPT can be applied in hospitals, specifically for children with epilepsy, to improve their quality of life, enhance problem-solving, and foster positive coping strategies. The goal is to validate CBPT as a supportive tool for enhancing psycho-emotional development and complementing medical care in hospital settings.

The study proposes a randomized controlled trial with two groups: children with epilepsy will be randomly assigned to either the cognitive-behavioral play intervention or free play. The study will assess internalizing and externalizing behaviors, coping strategies, positive thinking, problem-solving skills, and quality of life at baseline (T0) and after the 8 intervention sessions (T1).

The goal is to determine whether cognitive-behavioral play improves quality of life more than free play.

Both groups will participate in 8 weekly 40-minute play sessions, with an initial and final meeting to administer the questionnaires.

The psychologist conducting the assessments will be unaware of group assignments.

The play scenarios for both groups will be identical and based on common issues faced by children with epilepsy.

Study Timeline

• Study Start: 2024-10-07
• Status Verified: 2025-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
effect of cognitive behavioral play intervention on quality of life	2 months	To assess whether there is an improvement in the quality of life in children with epilepsy following a cognitive-behavioral play intervention , and whether these improvements are greater in this group compared to the control group.; The Pediatric Quality of Life Inventory (PedsQL) Epilepsy Module will be used to measure the variable targeted by the intervention. The questionnaire uses a 5-point scale ranging from 0 (Never a problem) to 4 (Almost always a problem) for child and parent-report forms. For overall scores, it's possible to calculate a summary score with a range from 0 (worst possible health-related quality of life) to 100 (best possible health-related quality of life). Higher scores on the PedsQL Epilepsy Module indicate a better outcome, reflecting better health-related quality of life. Lower scores suggest a worse outcome.

Secondary Outcome Measures

Name	Time	Method
effect of cognitive behavioral play intervention on coping strategies	2 months	To verify whether a cognitive-behavioral play intervention, structured according to the theoretical framework of Cognitive Behavioral Play Therapy, can lead to an improvement in using standardized questionnaire The Children's Coping Strategies Checklist-Revised (CCSC-R1). The CCSC-R1 uses a Likert-type scale, typically ranging from 1 (Never use this strategy) to 5 (Always use this strategy) for each individual item. The total score depends on how the individual items are scored, but overall, higher scores represent greater use of coping strategies.; Higher scores generally indicate greater use of coping strategies by the child. This is not necessarily a "better" or "worse" outcome in itself, but the effectiveness of coping strategies would depend on the context and type of coping used. For instance, adaptive coping strategies are generally considered positive, while maladaptive coping strategies might indicate poorer outcomes.
effect of cognitive behavioral play intervention on positive thinking	2 months	To verify whether a cognitive-behavioral play intervention, structured according to the theoretical framework of Cognitive Behavioral Play Therapy, can lead to an improvement in positive thinking,using standardized questionnaire: Positive Thinking Checklist (Checklist sul Pensiero Positivo) The scale typically uses a Likert-type scale ranging from 1 (Never) to 5 (Always), assessing how often an individual engages in positive thinking behaviors. Higher scores indicate more frequent use of positive thinking strategies, which generally reflect a better outcome, suggesting a more positive mindset or a greater tendency toward constructive thinking.

Trial Locations

Locations (1)

Child Neuropsichiatry; 🇮🇹 Pavia, Italy