NCT06045520

Brief Summary

The adolescent's search for self-discovery and identity in physical, psychosocial, cognitive and emotional areas may become more complex with epilepsy disease management. The adolescent's burden of treatment compliance may lead to poor adherence to the disease and worsen short- and long-term health outcomes. Disease self-management in epilepsy represents the processes required for disease knowledge, seizure control, medication adherence, increasing social support and quality of life, and reducing the negative effects of the disease. Educational training implemented in this period have an effect that increases motivation to gain skills to adapt to the disease. This model argues that knowledge is a basis for behaviour change, but it is not sufficient alone. However, it is argued that people will have the necessary behavioural skills when they are well informed and motivated for effective action. It is aimed to find a statistically significant difference from the scales (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Level of Social Support Scale, Child's Attitude Towards His/her Disease Scale) at the end of the training of adolescents who received an 8-week training program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

September 13, 2023

Last Update Submit

July 18, 2024

Conditions

Keywords

adolescentepilepsyeducation trainingpediatric nursingInformation-Motivation-Behavioral Skills Model

Outcome Measures

Primary Outcomes (4)

  • Change in the mean score of adolescents in the epilepsy disease knowledge test

    The "epilepsy knowledge test for adolescents" developed by the researchers consists of 25 items. The knowledge test includes true and false items. The items were evaluated with item prop. correct and item discrimination index ITEMAN analysis. The reliability coefficient, which provides evidence of the internal consistency of the knowledge test, was found to be KR-20 (Kuder-Richardson) = 0.813.

    an average of 3 month

  • Change in the mean score of adolescents in the Seizure Self-Efficacy Scale in Children with Epilepsy

    The scale, which was developed by Caplin et al. and whose Turkish validity and reliability study was conducted by Güven and İşler in 2015, is a 15-item 5-point Likert-type scale. It was conducted with children aged 9-18 years with epilepsy and the cronbach alpha value was found to be 0.89. The scale is a 15-item five-point Likert-type scale and the scale items are scored between 1-5. A high score on the scale is interpreted as an improved seizure self-efficacy of the child

    an average of 3 month

  • Change in the mean score of adolescents in the Multidimensional Perceived Social Support Scale

    The Multidimensional Perceived Social Support Scale was developed by Zimet et al. The Cronbach's alpha coefficient of the scale, whose validity and reliability study was performed by Eker et al. in 2001, was found to be 0.80-0.95. The scale consists of 12 items and evaluates social support received from three different sources. The scale consists of a 7-point Likert scale as "Absolutely no 1,2,3,4,5,5,6,7 Absolutely yes". The scale has a total of three sub-dimensions as family (mother, father, spouse, children and siblings), friend and special person support (dating, oral, fiancé, neighbour, relative, doctor) and each sub-dimension consists of 4 items. The sub-dimension scores are obtained by summing the four items in the sub-dimensions, and the total score is obtained by summing all sub-dimensions. A minimum score of 12 points and a maximum score of 84 points can be obtained from the scale. A high total score indicates a high level of perceived social support

    an average of 3 month

  • Change in the mean score of adolescents in theChild's Attitude Towards His Own Illness Scale

    The Turkish validity and reliability study of the scale developed by Austin and Huberty was conducted by Ersun and Bolışık. The scale, whose Cronbach Alpha value is 0.79, is a 5-point Likert type and consists of 15 items. The original scale was developed for children aged 8-12 with chronic diseases. However, in a systematic review of the scale, it was stated that it could be used safely between the ages of 8 and 22. 4 of the 13 items are bipolar adjectives (Very Good, Somewhat Good, Not Sure, Somewhat Bad, Very Bad) and 9 are from options expressing how often they experience the positive and negative aspects of having a chronic disease (Very Often, Often, Sometimes , Not Often, Never). Among the scale items scored between 1 and 5, 1 and 2 indicate negative attitude, 3 indicate neutral attitude, and 4 and 5 indicate positive attitude.

    an average of 3 month

Study Arms (2)

IBM Educational Training

EXPERIMENTAL

Intervention group participants will receive IBM skills model on educational training intervention for 8 weeks.

Behavioral: Information-Motivation-Behavioral Skills Model

Control Group

NO INTERVENTION

No intervention was applied to the control group.

Interventions

1.-2.Meeting:Regarding the information component of the IMB model; Answers given by the adolescents to the epilepsy knowledge test, the topics on which the adolescent wants to get information will be agreed with the adolescent and an education training will be created.3.,4.,5.-6. Meeting:Personal motivation, which is the first step of the motivation component; A meeting will be held regarding the obstacles to the disease, attitudes and behaviors towards the disease. In order to strengthen social support systems, a one-session seizure management training will be planned with a person chosen by the adolescent from his parent or friend group.7-8. Meeting:Seizure self-efficacy and treatment compliance will be evaluated in the behavioral skills component. During training, achievable goals will be set to ask the adolescent to provide personal feedback, ask open-ended questions, engage in reflective listening, and increase personal and social motivation to comply with medical recommendations

IBM Educational Training

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • For adolescents;
  • Those who agree to participate in the study and sign the Informed Voluntary Consent Form
  • Age between 12-18 years
  • Diagnosis of epilepsy
  • No communication barriers (visual, hearing, mental retardation)
  • No other chronic disease other than epilepsy
  • Being literacy

You may not qualify if:

  • For adolescents;
  • Refusal to participate in the study
  • Those who do not sign the Informed Volunteer Consent Form
  • Those who do not sign the Informed Volunteer Consent Form
  • Under 12 years old, over 18 years old,
  • No diagnosis of epilepsy
  • Communication disability (visual, hearing, mental retardation)
  • No another chronic disease other than epilepsy
  • Illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, 33343, Turkey (Türkiye)

Location

Related Publications (5)

  • Tutar Guven S, Isler Dalgic A, Duman O. Evaluation of the efficiency of the web-based epilepsy education program (WEEP) for youth with epilepsy and parents: A randomized controlled trial. Epilepsy Behav. 2020 Oct;111:107142. doi: 10.1016/j.yebeh.2020.107142. Epub 2020 Jul 21.

    PMID: 32702651BACKGROUND
  • Fisher JD, Amico KR, Fisher WA, Harman JJ. The information-motivation-behavioral skills model of antiretroviral adherence and its applications. Curr HIV/AIDS Rep. 2008 Nov;5(4):193-203. doi: 10.1007/s11904-008-0028-y.

    PMID: 18838059BACKGROUND
  • Fisher JD, Fisher WA, Williams SS, Malloy TE. Empirical tests of an information-motivation-behavioral skills model of AIDS-preventive behavior with gay men and heterosexual university students. Health Psychol. 1994 May;13(3):238-50. doi: 10.1037//0278-6133.13.3.238.

    PMID: 8055859BACKGROUND
  • Lerch MF, Thrane SE. Adolescents with chronic illness and the transition to self-management: A systematic review. J Adolesc. 2019 Apr;72:152-161. doi: 10.1016/j.adolescence.2019.02.010. Epub 2019 Mar 21.

    PMID: 30903932BACKGROUND
  • Braga P, Mifsud J, D'Souza C, Clarke M, Honein A, Tovuudorj A, Pfafflin M. Education and epilepsy: Examples of good practice and cooperation. Report of the IBE Commission on Education. Epilepsy Behav. 2020 Feb;103(Pt A):106653. doi: 10.1016/j.yebeh.2019.106653. Epub 2019 Nov 21.

    PMID: 31761687BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

Information Motivation Behavioral Skills Model

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Models, PsychologicalModels, TheoreticalInvestigative Techniques

Study Officials

  • Ayda Çelebioğlu

    Mersin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants were unaware of which group they were assigned to. The data will be entered using A and B codes, and the researcher doing the statistical analysis will be blind to the participants' groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research has a randomized controlled interventional study design. An impartial investigator who is not participating in the study will conduct the randomization. Six alternative combinations with a block size of four (ABAB(1), ABBA(2),...) containing codes A and B will be constructed using the block randomization method. From 1 to 6, combinations will be numbered. By sorting the integers (1-6) via randomizer.org 33 times in a random order, a random assignment sequence will be formed. By drawing lots with coins, it will be established which of the A and B codes is the intervention group and which is the control group. Participants who meet the inclusion criteria will be asked to sign an informed consent form, and their group will be shared with the researcher after the pre-tests (T1) are completed. In the intervention group, participants will get a web-based training based on the family-centered approach.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD (c), Nursing

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

November 15, 2023

Primary Completion

June 8, 2024

Study Completion

July 17, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Locations