Pediatric ALLNCT06412692
Motivational Interviewing in Adolescents With Epilepsy
A study testing The Motivational Interviewing Technique in people with Pediatric ALL, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Epilepsy is the most common serious neurodevelopmental disorder of childhood characterized by recurrent seizures, affecting approximately 0.9% of children and adolescents worldwide. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- The Motivational Interviewing Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Nov 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Be between the ages of 12-15
- Having epilepsy for at least six months
- Having a high score on the Social Anxiety Scale for Adolescents
- Having a low score on the General Child Life Quality Scale
- Low scores on the KINDL Epilepsy Quality of Life Module for Children
- No mental disability
Show all 10Show fewer
- Able to communicate (can speak and understand Turkish, has no speech disorder)
- Being literate
- Not having any other chronic disease
- Being willing to participate in the study
Who cannot join
- -Not attending at least one of the interviewing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Motivational Interviewıng Technique on Social Anxiety and Quality of Life of Adolescents With Epilepsy
Epilepsy is the most common serious neurodevelopmental disorder of childhood characterized by recurrent seizures, affecting approximately 0.9% of children and adolescents worldwide. Although epileptic seizures are an important element of epilepsy in children, there are many neurological, mental health and cognitive comorbidities in childhood epilepsy that increase the burden of the disease and cause a decrease in quality of life. Motivational interviewing has been found to have a positive effect on the treatment and prevention of chronic diseases; It is a patient-centered counseling that explores, strengthens, and directs the individual's motivation for change.
Read the detailed description
Adolescence period; It is an important stage of development in which the self-concept develops, self-related schemas are created and carried into adulthood. During this formative period of life; Adolescents experience increasing levels of uncertainty and self-consciousness as they progress through the task of identity formation. It is greatly influenced by social interactions, especially interactions with peers.Children and adolescents with epilepsy are at increased risk for social problems, reduced social competence, poor social skills, and deficits in social communication compared to healthy children. Compared to youth with other chronic diseases, youth with epilepsy have higher rates of comorbid neurological disorders, academic failure, poor social skills, stigma, poor quality of life, and behavioral health problems (e.g., anxiety, depression). They often experience low quality of life because they feel unsafe and fear having a seizure in public. In a study aiming to investigate the factors affecting the level of social anxiety in epilepsy, it was concluded that social anxiety is independently associated with low quality of life. In a meta-analysis study; It was concluded that the motivational interviewing method applied by nurses increased the quality of life of individuals with chronic diseases. When the literature was examined, no study was found that addressed the motivational interviewing technique applied to the social anxiety and quality of life of adolescents with epilepsy. Motivational Interviewing Technique applied to adolescents with epilepsy; It is thought that it will be effective in reducing social anxiety and increasing the quality of life by enabling adolescents to become aware of their situation, get rid of the ambivalent (opposite emotional state) they experience, and take action to change.
- Conditions
- Pediatric ALL
- Being tested
- The Motivational Interviewing Technique
- Keywords
- Epilepsy, Adolescent, Motivational Interviewing
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Motivational Interviewing TechniqueOther
Motivational interviewing technique applied to adolescents with epilepsy; It is thought that it will be effective in reducing social anxiety and increasing the quality of life of adolesce.
| Study group | Role | What they receive |
|---|---|---|
| The Motivational Interviewing Technique | Experimental | The Motivational Interviewing Technique Group (n=36) An equal number of patients will be classified by gender. Before the interview, each adolescent: Informed Consent Form, Personal Information Form, Social Anxiety Scale for Adolescents, Children's General Quality of Life Scale, and KINDL Epilepsy Quality of Life Module for Children will be applied. Interviews will be held in the training room next to the Child Neurology Polyclinic. In our study; The motivational interviewing technique will be applied to the experimental group individually by the researcher at 2-week intervals, including a preliminary interview and 6 motivational interview sessions. Each motivational interview will last approximately 40-50 minutes. One day before the motivational interview day, the experimental group will be informed by calling their registered phone numbers. The surveys will be re-administered after the end of the interview sessions. Surveys will be administered again after 1 month. Receives: Other: The Motivational Interviewing Technique |
| No Intervention | No intervention | No Intervention Group (n=36) Equal numbers of patients will be stratified according to gender. Adolescents without intervention; Patient Consent Form, Personal Information Form, Social Anxiety Scale in Adolescents, Child's General Quality of Life Scale, KINDL Epilepsy Quality of Life Module in Children will be applied. Routine follow-up and treatment will continue. The duration of the pre-interview and 6 motivational interviews will be calculated and the scales will be applied again.The surveys will be administered again after 1 month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Social Anxiety Scale for Adolescents" [Time Frame: After the motivational interviewing technique]
A high score on the Social Anxiety Scale for Adolescents indicates high anxiety.
Measured: 3 months
''KINDL Epilepsy Quality of Life Module for Children'' [Time Frame: After the motivational interviewing technique]
A high score on the KINDL Epilepsy Quality of Life Module for Children indicates good healthy quality of life.
Measured: 3 months
"Children's General Quality of Life Scale'' [Time Frame: After the motivational interviewing technique]
A high score on the Children's General Quality of Life Scale for Children indicates good healthy quality of life.
Measured: 3 months
"Social Anxiety Scale for Adolescents" [Time Frame: 1 month after the Motivational Interviewing Technique]
A high score on the Social Anxiety Scale for Adolescents indicates high anxiety.
Measured: 1 months
''KINDL Epilepsy Quality of Life Module for Children'' [Time Frame: 1 month after the Motivational Interviewing Technique]
A high score on the KINDL Epilepsy Quality of Life Module for Children indicates good healthy quality of life.
Measured: 1 months
"Children's General Quality of Life Scale" [Time Frame: 1 month after the Motivational Interviewing Technique]
A high score on the Children's General Quality of Life Scale for Children indicates good healthy quality of life.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start18 Nov 2023
- Primary completion20 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In our study; The motivational interview technique will be applied to the intervention group individually by the researcher at 2-week intervals, including a preliminary interview and 6 motivational interview sessions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ELİZ GECTAN, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412692
- Sponsor's protocol ID
- İzmirKCU-GECTAN-001
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clifford LM, Brothers SL, Lang A. Self-Disclosure Patterns Among Children and Youth with Epilepsy: Impact of Perceived-Stigma. Adolesc Health Med Ther. 2023 Feb 5;14:27-43. doi: 10.2147/AHMT.S336124. eCollection 2023.
PubMed 36776152Tolchin B, Baslet G, Martino S, Suzuki J, Blumenfeld H, Hirsch LJ, Altalib H, Dworetzky BA. Motivational Interviewing Techniques to Improve Psychotherapy Adherence and Outcomes for Patients With Psychogenic Nonepileptic Seizures. J Neuropsychiatry Clin Neurosci. 2020 Spring;32(2):125-131. doi: 10.1176/appi.neuropsych.19020045. Epub 2019 Aug 30.
PubMed 31466516Tolchin B, Baslet G, Suzuki J, Martino S, Blumenfeld H, Hirsch LJ, Altalib H, Dworetzky BA. Randomized controlled trial of motivational interviewing for psychogenic nonepileptic seizures. Epilepsia. 2019 May;60(5):986-995. doi: 10.1111/epi.14728. Epub 2019 Apr 13.
PubMed 30980679Vallabhan MK, Jimenez EY, Nash JL, Gonzales-Pacheco D, Coakley KE, Noe SR, DeBlieck CJ, Summers LC, Feldstein-Ewing SW, Kong AS. Motivational Interviewing to Treat Adolescents With Obesity: A Meta-analysis. Pediatrics. 2018 Nov;142(5):e20180733. doi: 10.1542/peds.2018-0733. Epub 2018 Oct 22.
PubMed 30348753Aburahma SK, Hammouri H, Hazaimeh E, Jbarah O, Nassar A, Almasri A, Al Momani M, Bashtawi M. Social impairment in children with epilepsy assessed by the social responsiveness scale. Clin Child Psychol Psychiatry. 2021 Oct;26(4):1170-1181. doi: 10.1177/13591045211033176. Epub 2021 Jul 16.
PubMed 34271834Hosseini N, Mokhtari S, Momeni E, Vossoughi M, Barekatian M. Effect of motivational interviewing on quality of life in patients with epilepsy. Epilepsy Behav. 2016 Feb;55:70-4. doi: 10.1016/j.yebeh.2015.10.012. Epub 2016 Jan 12.
PubMed 26773672Lu Y, Zhong R, Li M, Zhao Q, Zhang X, Hu B, Lin W. Social anxiety is associated with poor quality of life in adults with epilepsy in Northeast China: A cross-sectional study. Epilepsy Behav. 2021 Apr;117:107866. doi: 10.1016/j.yebeh.2021.107866. Epub 2021 Mar 5.
PubMed 33684784Uzun S, Ozmaya E. The effect of motivational interview conducted by nurses on quality of life: Meta-analysis. Perspect Psychiatr Care. 2022 Oct;58(4):2449-2459. doi: 10.1111/ppc.13080. Epub 2022 Apr 5.
PubMed 35383938
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewıng Technique on Social Anxiety and Quality of Life of Adolescents With Epilepsy
- ClinicalTrials.gov ID
- NCT06412692
- Acronym / sponsor ID
- İzmirKCU-GECTAN-001
- Conditions
- Pediatric ALL
- Keywords
- Epilepsy, Adolescent, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 18 Nov 2023 (actual)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 May 2024 (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.
Epilepsy is the most common serious neurodevelopmental disorder of childhood characterized by recurrent seizures, affecting approximately 0.9% of children and adolescents worldwide. Although epileptic seizures are an important element of epilepsy in children, there are many neurological, mental health and cognitive comorbidities in childhood epilepsy that increase the burden of the disease and cause a decrease in quality of life. Motivational interviewing has been found to have a positive effect on the treatment and prevention of chronic diseases; It is a patient-centered counseling that explores, strengthens, and directs the individual's motivation for change.
Detailed description
Adolescence period; It is an important stage of development in which the self-concept develops, self-related schemas are created and carried into adulthood. During this formative period of life; Adolescents experience increasing levels of uncertainty and self-consciousness as they progress through the task of identity formation. It is greatly influenced by social interactions, especially interactions with peers.Children and adolescents with epilepsy are at increased risk for social problems, reduced social competence, poor social skills, and deficits in social communication compared to healthy children. Compared to youth with other chronic diseases, youth with epilepsy have higher rates of comorbid neurological disorders, academic failure, poor social skills, stigma, poor quality of life, and behavioral health problems (e.g., anxiety, depression). They often experience low quality of life because they feel unsafe and fear having a seizure in public. In a study aiming to investigate the factors affecting the level of social anxiety in epilepsy, it was concluded that social anxiety is independently associated with low quality of life. In a meta-analysis study; It was concluded that the motivational interviewing method applied by nurses increased the quality of life of individuals with chronic diseases. When the literature was examined, no study was found that addressed the motivational interviewing technique applied to the social anxiety and quality of life of adolescents with epilepsy. Motivational Interviewing Technique applied to adolescents with epilepsy; It is thought that it will be effective in reducing social anxiety and increasing the quality of life by enabling adolescents to become aware of their situation, get rid of the ambivalent (opposite emotional state) they experience, and take action to change.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In our study; The motivational interview technique will be applied to the intervention group individually by the researcher at 2-week intervals, including a preliminary interview and 6 motivational interview sessions.
| Arm | Type | Receives |
|---|---|---|
| The Motivational Interviewing Technique | Experimental | Other: The Motivational Interviewing TechniqueThe Motivational Interviewing Technique Group (n=36) An equal number of patients will be classified by gender. Before the interview, each adolescent: Informed Consent Form, Personal Information Form, Social Anxiety Scale for Adolescents, Children's General Quality of Life Scale, and KINDL Epilepsy Quality of Life Module for Children will be applied. Interviews will be held in the training room next to the Child Neurology Polyclinic. In our study; The motivational interviewing technique will be applied to the experimental group individually by the researcher at 2-week intervals, including a preliminary interview and 6 motivational interview sessions. Each motivational interview will last approximately 40-50 minutes. One day before the motivational interview day, the experimental group will be informed by calling their registered phone numbers. The surveys will be re-administered after the end of the interview sessions. Surveys will be administered again after 1 month. |
| No Intervention | No intervention | –No Intervention Group (n=36) Equal numbers of patients will be stratified according to gender. Adolescents without intervention; Patient Consent Form, Personal Information Form, Social Anxiety Scale in Adolescents, Child's General Quality of Life Scale, KINDL Epilepsy Quality of Life Module in Children will be applied. Routine follow-up and treatment will continue. The duration of the pre-interview and 6 motivational interviews will be calculated and the scales will be applied again.The surveys will be administered again after 1 month. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Be between the ages of 12-15
- Having epilepsy for at least six months
- Having a high score on the Social Anxiety Scale for Adolescents
- Having a low score on the General Child Life Quality Scale
- Low scores on the KINDL Epilepsy Quality of Life Module for Children
Key exclusion criteria (1 listed)
- -Not attending at least one of the interviewing
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 |
|---|---|---|
| The Motivational Interviewing TechniqueMotivational interviewing technique applied to adolescents with epilepsy; It is thought that it will be effective in reducing social anxiety and increasing the quality of life of adolesce. | Other | The Motivational Interviewing Technique |
Primary outcome
"Social Anxiety Scale for Adolescents" [Time Frame: After the motivational interviewing technique]
Time frame: 3 months
A high score on the Social Anxiety Scale for Adolescents indicates high anxiety.
''KINDL Epilepsy Quality of Life Module for Children'' [Time Frame: After the motivational interviewing technique]
Time frame: 3 months
A high score on the KINDL Epilepsy Quality of Life Module for Children indicates good healthy quality of life.
"Children's General Quality of Life Scale'' [Time Frame: After the motivational interviewing technique]
Time frame: 3 months
A high score on the Children's General Quality of Life Scale for Children indicates good healthy quality of life.
"Social Anxiety Scale for Adolescents" [Time Frame: 1 month after the Motivational Interviewing Technique]
Time frame: 1 months
A high score on the Social Anxiety Scale for Adolescents indicates high anxiety.
''KINDL Epilepsy Quality of Life Module for Children'' [Time Frame: 1 month after the Motivational Interviewing Technique]
Time frame: 1 months
A high score on the KINDL Epilepsy Quality of Life Module for Children indicates good healthy quality of life.
"Children's General Quality of Life Scale" [Time Frame: 1 month after the Motivational Interviewing Technique]
Time frame: 1 months
A high score on the Children's General Quality of Life Scale for Children indicates good healthy quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 36776152Clifford LM, Brothers SL, Lang A. Self-Disclosure Patterns Among Children and Youth with Epilepsy: Impact of Perceived-Stigma. Adolesc Health Med Ther. 2023 Feb 5;14:27-43. doi: 10.2147/AHMT.S336124. eCollection 2023.
- Background: PubMed 31466516Tolchin B, Baslet G, Martino S, Suzuki J, Blumenfeld H, Hirsch LJ, Altalib H, Dworetzky BA. Motivational Interviewing Techniques to Improve Psychotherapy Adherence and Outcomes for Patients With Psychogenic Nonepileptic Seizures. J Neuropsychiatry Clin Neurosci. 2020 Spring;32(2):125-131. doi: 10.1176/appi.neuropsych.19020045. Epub 2019 Aug 30.
- Background: PubMed 30980679Tolchin B, Baslet G, Suzuki J, Martino S, Blumenfeld H, Hirsch LJ, Altalib H, Dworetzky BA. Randomized controlled trial of motivational interviewing for psychogenic nonepileptic seizures. Epilepsia. 2019 May;60(5):986-995. doi: 10.1111/epi.14728. Epub 2019 Apr 13.
- Background: PubMed 30348753Vallabhan MK, Jimenez EY, Nash JL, Gonzales-Pacheco D, Coakley KE, Noe SR, DeBlieck CJ, Summers LC, Feldstein-Ewing SW, Kong AS. Motivational Interviewing to Treat Adolescents With Obesity: A Meta-analysis. Pediatrics. 2018 Nov;142(5):e20180733. doi: 10.1542/peds.2018-0733. Epub 2018 Oct 22.
- Background: PubMed 34271834Aburahma SK, Hammouri H, Hazaimeh E, Jbarah O, Nassar A, Almasri A, Al Momani M, Bashtawi M. Social impairment in children with epilepsy assessed by the social responsiveness scale. Clin Child Psychol Psychiatry. 2021 Oct;26(4):1170-1181. doi: 10.1177/13591045211033176. Epub 2021 Jul 16.
- Background: PubMed 26773672Hosseini N, Mokhtari S, Momeni E, Vossoughi M, Barekatian M. Effect of motivational interviewing on quality of life in patients with epilepsy. Epilepsy Behav. 2016 Feb;55:70-4. doi: 10.1016/j.yebeh.2015.10.012. Epub 2016 Jan 12.
- Background: PubMed 33684784Lu Y, Zhong R, Li M, Zhao Q, Zhang X, Hu B, Lin W. Social anxiety is associated with poor quality of life in adults with epilepsy in Northeast China: A cross-sectional study. Epilepsy Behav. 2021 Apr;117:107866. doi: 10.1016/j.yebeh.2021.107866. Epub 2021 Mar 5.
- Background: PubMed 35383938Uzun S, Ozmaya E. The effect of motivational interview conducted by nurses on quality of life: Meta-analysis. Perspect Psychiatr Care. 2022 Oct;58(4):2449-2459. doi: 10.1111/ppc.13080. Epub 2022 Apr 5.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Motivational Interviewing Technique in people with Pediatric ALL, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 10 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 May 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Social Anxiety Scale for Adolescents" [Time Frame: After the motivational interviewing technique] (time frame: 3 months). The study lists 6 primary outcomes in all. 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 NCT06412692, which also lists 8 linked publications.
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 14 May 2024.