Effect of Cognitive Behavioral Play Intervention and Epilepsy
NCT06813612 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2025-02-07
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.
Conditions
- Epilepsy
- Epilepsy in Children
Interventions
- BEHAVIORAL
-
cognitive behavioral play intervention
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.
Sponsors & Collaborators
-
Centro Ricerca "CBPT" Roma
collaborator UNKNOWN -
IRCCS National Neurological Institute "C. Mondino" Foundation
lead OTHER
Principal Investigators
-
martina paola p zanaboni, psy · IRCCS Mondino Foundation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-07
- Primary Completion
- 2025-10-31
- Completion
- 2026-10-31
Countries
- Italy
Study Locations
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