Child Neuropsichiatry
Pavia, 27100, Italy
Location status: Recruiting
Location contact
Cinzia Fattore, MD
CONTACT
0382 380385 ext. 0039
Valentina De Giorgis, MD
CONTACT
0382 380289 ext. 0039
NCT Number: NCT06813612
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.
Interested in participating?
Request Info6 year–10 year
All sexes
Interventional
Not applicable
Pavia, 27100, Italy
Location status: Recruiting
Cinzia Fattore, MD
CONTACT
0382 380385 ext. 0039
Valentina De Giorgis, MD
CONTACT
0382 380289 ext. 0039
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
For the purposes of the study, children aged between 6 and 10 years, of both sexes, will be recruited.
Exclusion criteria
In the CBPI condition, children use dolls and miniature props to engage in play aimed at fostering positive thinking, a key element of quality of life. Each session includes stories on health, emotional well-being, social interactions, and school activities. The researcher demonstrates problem-solving steps, such as identifying and evaluating solutions, repeating this process three times. In each session, the researcher models problem-solving four times and provides at least five positive affirmations. Both the CBPI intervention and the free play control condition are similar, with the researcher using standardized prompts and providing equal time and positive attention. The key difference is that in the CBPI condition, the researcher models positive thinking and problem-solving, while in the free play condition, the researcher follows the child's lead without guiding play.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Valentina De Giorgis, MD PhD
CONTACT
0382380289 ext. +39
martina p zanaboni, psy
CONTACT
3495788291 ext. +39
IRCCS National Neurological Institute "C. Mondino" Foundation
Other
The Effects of Cognitive Behavioral Play Intervention on the Quality of Life of Children With Childhood-onset Epileptic Syndromes."
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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