EpilepsyNCT06813612
Effect of Cognitive Behavioral Play Intervention and Epilepsy
A study testing cognitive behavioral play intervention in people with Epilepsy and Epilepsy in Children, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Epilepsy, Epilepsy in Children
- What is being tested?
- cognitive behavioral play intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 7 Oct 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Child Neuropsichiatry
Pavia, 27100
Valentina De Giorgis, MD, 0382 380289 ext. 0039, valentina.degiorgis@mondino.it
Cinzia Fattore, MD, 0382 380385 ext. 0039, cinzia.fattore@mondino.it
About this study
Official title: The Effects of Cognitive Behavioral Play Intervention on the Quality of Life of Children With Childhood-onset Epileptic Syndromes."
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.
Read the 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.
- Conditions
- Epilepsy, Epilepsy in Children
- Being tested
- cognitive behavioral play intervention
- Keywords
- epilepsy, psychology, cognitive behavioral play therapy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral play interventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (2)
effect of cognitive behavioral play intervention on coping strategies
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.
Measured: 2 months
effect of cognitive behavioral play intervention on positive thinking
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start7 Oct 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Ricerca "CBPT" Roma
- Responsible party
- Sponsor
- Investigators
- martina paola p zanaboni, psy, Principal investigator, IRCCS Mondino Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813612
- Sponsor's protocol ID
- cbpt epi
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35503717
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cognitive Behavioral Play Intervention on the Quality of Life of Children With Childhood-onset Epileptic Syndromes."
- ClinicalTrials.gov ID
- NCT06813612
- Acronym / sponsor ID
- cbpt epi
- Conditions
- Epilepsy, Epilepsy in Children
- Keywords
- epilepsy, psychology, cognitive behavioral play therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Collaborators
- Centro Ricerca "CBPT" Roma
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Experimental condition cognitive behavioral play intervention CBPI | Experimental | Behavioral: cognitive behavioral play interventionIn 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 |
| 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral play interventionIn 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. | Behavioural | Experimental condition cognitive behavioral play intervention CBPI |
Primary outcome
effect of cognitive behavioral play intervention on quality of life
Time frame: 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.
2 secondary outcomes
effect of cognitive behavioral play intervention on coping strategies
Time frame: 2 months
effect of cognitive behavioral play intervention on positive thinking
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 35503717Specchio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
martina paola p zanaboni, psy principal investigator
IRCCS Mondino Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral play intervention in people with Epilepsy and Epilepsy in Children, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina De Giorgis, MD PhD (0382380289 ext. +39, valentina.degiorgis@mondino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of cognitive behavioral play intervention on quality of life (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025; AzTrials last refreshed its copy on 1 Nov 2026.