Effect of Cognitive Behavioral Play Intervention and Epilepsy

Официальное название

The Effects of Cognitive Behavioral Play Intervention on the Quality of Life of Children With Childhood-onset Epileptic Syndromes."

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 affirm

Первичные конечные точки

• effect of cognitive behavioral play intervention on quality of life [Срок оценки: 2 months]

Вторичные конечные точки (2)

• effect of cognitive behavioral play intervention on coping strategies [Срок оценки: 2 months]
• effect of cognitive behavioral play intervention on positive thinking [Срок оценки: 2 months]

Критерии участия

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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Child Neuropsichiatry — Pavia

Публикации

• 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. PMID 35503717

Идентификаторы

NCT: NCT06813612 · cbpt epi

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗