Effect of Cognitive Behavioral Play Intervention and Epilepsy

NCT06813612 | Recruiting

• 1 other identifier: cbpt epi
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Epilepsy in Children

Keywords

epilepsy; psychology; cognitive behavioral play therapy

Outcome Measures

Primary Outcomes (1)

• effect of cognitive behavioral play intervention on quality of life

  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.

  2 months

Secondary Outcomes (2)

• effect of cognitive behavioral play intervention on coping strategies

  2 months

• effect of cognitive behavioral play intervention on positive thinking

  2 months

Study Arms (2)

Experimental condition cognitive behavioral play intervention CBPI

EXPERIMENTAL

In the CBPI condition, children are given dolls and miniature props to play with, aiming to promote positive thinking. Each session includes stories on health, emotional well-being, social activities, and school life. The researcher teaches problem-solving by modeling steps like identifying the problem, generating solutions, evaluating them, and choosing the best solution. In each session, the researcher models the process four times and makes positive affirmations. The CBPI intervention and the free play control condition are similar, with both groups engaging in pretend play. The researcher uses standardized prompts and spends equal time and attention with each child. The key difference is that in the CBPI intervention, the researcher uses dolls to model positive thinking and problem-solving, while encouraging children's imagination and emotional expression. Techniques from play therapy are used to help children integrate their feelings into the stories

Behavioral: cognitive behavioral play intervention

control condition of free playFP

NO INTERVENTION

The free play (FP) control condition allows the researcher to assess the effects of pretend play and provide positive attention to children. Children in this condition receive the same dolls and props, and hear the same stories as those in the cognitive-behavioral play intervention. After each story, they are encouraged to create their own story, but are free to play as they wish, often engaging in play unrelated to the story prompt. The researcher follows the child's lead, offering positive attention and non-specific praise but does not guide the play. The main difference between the two conditions is that in the FP condition, the researcher provides attention without directing the play, while in the intervention condition, the researcher actively guides the child's play to model problem-solving and positive thinking.

Interventions

cognitive behavioral play intervention BEHAVIORAL

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.

Experimental condition cognitive behavioral play intervention CBPI

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead
• Centro Ricerca "CBPT" Roma: collaborator

Study Sites (1)

Child Neuropsichiatry

Pavia, 27100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 35503717 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• martina paola p zanaboni, psy

  IRCCS Mondino Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina De Giorgis, MD PhD

CONTACT

0382380289; valentina.degiorgis@mondino.it

martina p zanaboni, psy

CONTACT

3495788291; martinapaola.zanaboni@mondino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 7, 2025
• Study Start: October 7, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)