Effect of Cognitive Behavioral Play Intervention and Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Children with epilepsy in comorbidity with cognitive disabilities (the relevant cognitive disabilities must be specified with IQ scores)
reduced visual or expressive hearing acuity (visually impaired or deaf) will be excluded.
Trial design
Design model
Parallel
Treatments tested in this trial
cognitive behavioral play intervention
BehavioralIn 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.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Experimental condition cognitive behavioral play intervention CBPIExperimental treatment 1 intervention
Group B: control condition of free playFPNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
effect of cognitive behavioral play intervention on quality of life
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 monthsSecondary outcomes
1
effect of cognitive behavioral play intervention on coping strategies
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 months2
effect of cognitive behavioral play intervention on positive thinking
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.
Time frame
2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS National Neurological Institute "C. Mondino" Foundation
Lead sponsor
Centro Ricerca "CBPT" Roma
Collaborator
Source ClinicalTrials.gov