Ireland
--:--IST
Recruiting Not applicable

Effect of Cognitive Behavioral Play Intervention and Epilepsy

NCT06813612 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-10-07
Last updated
2025-02-07

Condition(s) studied

EpilepsyEpilepsy in Children

Investigational drug(s) / intervention(s)

cognitive behavioral play intervention

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.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
10 Years
Healthy volunteers
No
For the purposes of the study, children aged between 6 and 10 years, of both sexes, will be recruited. \- inclusion criteria Children diagnosed with the following types of epilepsy will be included: childhood self-limiting focal epilepsy (SeLFE); childhood absence epilepsy (CAE); self-limiting centrotemporal paroxysmal epilepsy (SeLECTS); self-limiting epilepsy with autonomic seizures (SeLEAS); childhood occipital epilepsy (COVE); photosensitive occipital lobe epilepsy (POLE). Exclusion criteria: * 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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Child Neuropsichiatry Pavia Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06813612 on ClinicalTrials.gov ↗ ← All trials in Italy