Clinical trial NCT06813612: Effect of Cognitive Behavioral Play Intervention and Epilepsy
Official title: The Effects of Cognitive Behavioral Play Intervention on the Quality of Life of Children With Childhood-onset Epileptic Syndromes."
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Epilepsy in Children
Keywords: epilepsy
psychology
cognitive behavioral play therapy
Lead sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Sponsor class: OTHER
Collaborators: name: Centro Ricerca "CBPT" Roma
First posted: 2025-02-07
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients consecutively enrolled will be assigned using a standard numerical randomization procedure. The randomization process will be carried out through the random sequence generator: www.randomizer.org. The required parameters will be entered into the generator (2 groups of 26 participants each for a sequence from 1 to 52 elements through extraction without replacement).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 outcomes:
measure: effect of cognitive behavioral play intervention on quality of life
timeFrame: 2 months
Secondary outcomes:
measure: effect of cognitive behavioral play intervention on coping strategies
timeFrame: 2 months
measure: effect of cognitive behavioral play intervention on positive thinking
timeFrame: 2 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Child Neuropsichiatry
Study officials:
affiliation: IRCCS Mondino Foundation
name: martina paola p zanaboni, psy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Specchio N, Wirrell EC, Scheffer IE, Nabbout R, Riney K, Samia P, Guerreiro M, Gwer S, Zuberi SM, Wilmshurst JM, Yozawitz E, Pressler R, Hirsch E, Wiebe S, Cross HJ, Perucca E, Moshe SL, Tinuper P, Auvin S. International League Against Epilepsy classification and definition of epilepsy syndromes with onset in childhood: Position paper by the ILAE Task Force on Nosology and Definitions. Epilepsia. 2022 Jun;63(6):1398-1442. doi: 10.1111/epi.17241. Epub 2022 May 3.