NCT06412692

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

April 30, 2024

Last Update Submit

May 8, 2024

Conditions

Keywords

EpilepsyAdolescentMotivational Interviewing

Outcome Measures

Primary Outcomes (6)

  • "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.

    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.

    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.

    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.

    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.

    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.

    1 months

Study Arms (2)

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.

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.

Interventions

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.

The Motivational Interviewing Technique

Eligibility Criteria

Age12 Years - 15 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsExperimental and control groups were selected based on randomization gender.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Not attending at least one of the interviewing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmirKCU

Izmir, Çigli, 35620, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 36776152BACKGROUND
  • Tolchin 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.

    PMID: 31466516BACKGROUND
  • Tolchin 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.

    PMID: 30980679BACKGROUND
  • Vallabhan 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.

    PMID: 30348753BACKGROUND
  • Aburahma 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.

    PMID: 34271834BACKGROUND
  • Hosseini 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.

    PMID: 26773672BACKGROUND
  • Lu 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.

    PMID: 33684784BACKGROUND
  • Uzun 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.

    PMID: 35383938BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaEpilepsy

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Randomized
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 14, 2024

Study Start

November 18, 2023

Primary Completion

May 20, 2024

Study Completion

December 31, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations