Epilepsy, Epilepsy in Children
Conditions
Keywords
epilepsy, psychology, cognitive behavioral play therapy
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.
Interventions
BEHAVIORALcognitive 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
Centro Ricerca CBPT Roma
IRCCS National Neurological Institute C. Mondino Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The person responsible for enrollment and the one responsible for pre- and post-intervention evaluations of participants will be blinded (single-blind) to the assignment to intervention conditions. Unblinding of the intervention condition may occur in the case of adverse clinical conditions that may arise during the study or due to the participants' early withdrawal from the study at their personal request. The person responsible for randomization and statistical analyses, as well as those who will administer the treatments, will be aware of the participants' assignment condition.
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).
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effect of cognitive behavioral play intervention on coping strategies | 2 months | 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. |
| effect of cognitive behavioral play intervention on positive thinking | 2 months | 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. |
Countries
Italy
Contacts
Primary ContactValentina De Giorgis, MD PhD
Backup Contactmartina p zanaboni, psy
Outcome results
None listed