Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04533776
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2020-08-10
Brief Title:
Support for Adolescents With Celiac Disease
Sponsor:
Melike Taşdelen Baş
Organization:
Selcuk University
Study Overview
Official Title:
Peer-Interaction Group Support in Adolescents With Celiac Disease A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed as a randomized controlled experimental study to examine the effects of peer-interaction group support in adolescents with celiac disease CD in the 13-18 age group on the quality of life friendship relations and coping levels of adolescents
Six peer interactive group sessions were held with one week intervals with adolescents n 18 in the study group included in the sample for a period of 3 months In the sessions all participants were asked questions about the purpose of the session and a discussion environment was created No training and counseling were provided to the adolescents in the control group n 18 Before and after the peer interactive group support adolescents in the intervention and control group were asked to complete the quality of life friendship qualities and coping scales
Six peer interactive group sessions were held with one week intervals with adolescents n 18 in the study group included in the sample for a period of 3 months In the sessions all participants were asked questions about the purpose of the session and a discussion environment was created No training and counseling were provided to the adolescents in the control group n 18 Before and after the peer interactive group support adolescents in the intervention and control group were asked to complete the quality of life friendship qualities and coping scales
Detailed Description:
The study is a randomized controlled experimental study conducted to examine the effect of peer interactive group support on quality of life peer relationships and coping coping levels in adolescents aged 13-18 years with celiac disease
The study was conducted on adolescents with a diagnosis of celiac disease in the outpatient clinic of the Department of Child Health of Afyon Kocatepe University in Afyonkarahisar This change took place after research permissions were obtained Patients are served in the polyclinic between 0900 and 1700 on weekdays Gastroenterology Specialist who monitors the patients with Celiac diagnosis works as a physician There are no nurses in the polyclinic and individual training is not given to celiac patients according to their needs
There are 85 patients with a diagnosis of celiac disease in the 0-18 age group who were followed up in the Department of Child Health and Diseases of Afyonkarahisar Health Sciences University where the study will be conducted It was determined from the patient records that there were 36 patients with a diagnosis of celiac disease in the 13-18 age group The universe of the study consisted of patients with a diagnosis of celiac disease in the 13-18 age group who were followed up in the Pediatric Outpatient Clinic of Afyonkarahisar University of Health Sciences
Data Collection Tools Introductory Information Form Quality of Life Scale for Children 13-18 age group Friendship Qualities Scale and Coping Scale for Adolescents prepared by the researcher for data collection
Introductory Information Form In this form prepared by the researcher there are 14 questions regarding the demographic characteristics of the mother father family and child After randomization an introductory information form before peer interactive group support was administered to all adolescents in the research and control groups in a classroom of the Pediatric Outpatient Clinic where the study was conducted
Childrens Quality of Life Scale - PedsQL 13-18 age group The quality of life scale for children was developed by Varni et al 1999 to measure the quality of life of children and adolescents aged 2-18 years The internal consistency coefficient Cronbachs alpha of the section prepared for children of the scale developed by Varni et al Was found to be 093 Memik et al 2007 conducted a study on the validity and reliability of the adolescent form of the PedsQL 13-18 years old
While the World Health Organization defines health it covers the areas of physical emotional and social functionality Scoring is made for these three areas in the scale In the scale a fourth area under the name of school functionality is questioned The psychosocial health total score PSTP is calculated by calculating the total score STP physical health total score FSTP emotional social and school functionality item scores in the scale
The Quality of Life Scale for Children PedsQL is a scale suitable for use in healthy or ill children and adolescents in settings such as schools and hospitals The scale consists of 23 items in total The scale is in the form of a 5-point Likert scale and is scored between 0-4 The items are scored between 0-100 The scale gives 100 points for never answer rarely 75 points for its answer sometimes 50 points for its answer often 25 points for its answer and almost always 0 points for its answer The Turkish validity and reliability study of the PedsQL for the 13-18 age group was conducted by Memik et al 2007 The internal consistency coefficient Cronbachs alpha of the form prepared for adolescents in the study of Memik et al Was found to be 082
Friendship Qualities Scale The friendship qualities scale aims to evaluate the relationships of 10-18 year old children and adolescents with their best friends The scale was created by Bukowski et al 1994 The internal consistency coefficients Cronbachs alpha according to the sub-dimensions of the scale were 072 conflict 068 proximity 076 help 081 and protection found to be 058 The Turkish validity and reliability study of the scale was conducted by Erkan Atik et al 2014 Participants included in the study are secondary and high school students The internal consistency coefficient of the whole scale in the study of Erkan Atik et al Was found to be 085 The scale includes 22 items and five sub-dimensions The scale is graded from 1 to 5 1 is not right for your friendship 2 may be correct 3 is usually correct 4 is very correct 5 is completely correct The sub-dimensions of the scale are togetherness conflict assistance protection and closeness Togetherness sub-dimension items 1 2 3 and 4 conflict sub-dimension 567 and 8 items help sub-dimension 9101112 and 13 items protection sub-dimension 141516 and 17th items proximity sub-dimension is calculated by evaluating items 18192021 and 22 All items in the conflict sub-dimension of the scale are calculated by reverse coding The scores that can be obtained vary between 4-20 in the Togetherness Conflict and Protection sub-dimensions and 5-25 in the Assistance and Proximity sub-dimensions If the scale score to be obtained from both the total score and the sub-dimensions is high this is considered as positive peer relationships
Coping Scale for Adolescents KIDCOPE The scale which was created by Spirito et al 1988 under the name of KIDCOPE multidimensional coping strategies for children scale consists of two forms for children 5-13 years old and adolescents 13-18 years The internal consistency coefficient Cronbachs alpha of the scale was 062 The Coping Scale for Adolescents consists of 11 items in total This scale includes ten coping strategies These strategies include social distancing distraction desiring thinking problem solving withdrawal cognitive restructuring social support emotion regulation self-criticism and blaming others
The 10 strategies included in KIDCOPE are distraction played a game to watch or forget TV withdrawal left alone desiresing thinking wanted to be able to do things differently self-criticism blamed myself blaming others blaming someone else for causing the problem problem solving I tried to solve the problem by thinking about the answers emotion regulation tried to calm myself or yelled screamed cognitive restructuring tried to see the good side of things social support tried to feel better by spending time with family or friends and social distancing I didnt want to spend time with my family or friends The 10 strategies included in KIDCOPE are distraction played a game to watch or forget TV withdrawal left alone desiresing thinking wanted to be able to do things differently self-criticism blamed myself blaming others blaming someone else for causing the problem problem solving I tried to solve the problem by thinking about the answers emotion regulation tried to calm myself or yelled screamed cognitive restructuring tried to see the good side of things social support tried to feel better by spending time with family or friends and social distancing I didnt want to spend time with my family or friends In the implementation phase of the study a classroom belonging to the Child Health and Diseases Polyclinic of Afyonkarahisar Health Sciences University Faculty of Medicine Hospital was used All sessions in the research were held in this classroom The sessions lasted an average of 90 minutes in two 45-minute sections Gluten-free products were presented during the 20-minute break between sessions During the break adolescents were given the opportunity to interact with each other by chatting The pre-test application of the introductory information form and scale forms of all the participants in the research group was applied at the beginning of the first session and the post-test application at the end of the last session which was the sixth session The pre-test application of the participants included in the control group was applied on the same day separately from the research group and the post-test application only scales was applied in the same classroom at the end of all sessions
Research Group Interactive peer group support was implemented for 3 months one week apart A total of 6 sessions were held with the research group Group meetings were planned to be held at the weekend in order to prevent adolescents attendance at school However as the data collection phase is in the summer and schools are closed the sessions were held on weekdays and bi-weekly The adolescents in the study group were reached by phone before each session One day before the session all participants were sent a text message informing the meeting and its place and time and they were invited Each session lasted 15 hours on average
The contents of the first and second sessions of the research were prepared beforehand However the contents of the third fourth fifth and sixth sessions were arranged after the first two sessions Table of contents of the 6 sessions held is presented in Table 3
In the sessions all participants were asked questions regarding the target determined for the session By creating a discussion environment based on these questions it was ensured that the participants shared their problems and solutions with each other The responses of the participants to the questions were noted and reported by the researcher
Control Group No peer interactive group support was provided to the control group In the control group in a classroom belonging to the Universitys Child Health and Diseases Polyclinic where the study was conducted the Introductory Information Form the Quality of Life Scale for Children the Friendship Qualities Scale the Adolescent Coping Scale were applied after the adolescents and parents were informed about the subject of the study and written permission was obtained Three months later the Adolescents in the control group were administered the Quality of Life Scale for Children Friendship Qualities Scalee and the Adolescent Coping Scale
The adolescents in the control group were not informed about the routine education they received from the hospital during the study A separate training meeting was held for the control group on 11102018 after all sessions of the peer interactive group support of the study were completed The training lasted about one hour in the classroom of the Universitys Child Health and Diseases Polyclinic The definition symptoms and signs of celiac disease treatment and dietary rules were discussed in the training content At the end of the meeting an information booklet titled Living with Celiacs was given
The study was conducted on adolescents with a diagnosis of celiac disease in the outpatient clinic of the Department of Child Health of Afyon Kocatepe University in Afyonkarahisar This change took place after research permissions were obtained Patients are served in the polyclinic between 0900 and 1700 on weekdays Gastroenterology Specialist who monitors the patients with Celiac diagnosis works as a physician There are no nurses in the polyclinic and individual training is not given to celiac patients according to their needs
There are 85 patients with a diagnosis of celiac disease in the 0-18 age group who were followed up in the Department of Child Health and Diseases of Afyonkarahisar Health Sciences University where the study will be conducted It was determined from the patient records that there were 36 patients with a diagnosis of celiac disease in the 13-18 age group The universe of the study consisted of patients with a diagnosis of celiac disease in the 13-18 age group who were followed up in the Pediatric Outpatient Clinic of Afyonkarahisar University of Health Sciences
Data Collection Tools Introductory Information Form Quality of Life Scale for Children 13-18 age group Friendship Qualities Scale and Coping Scale for Adolescents prepared by the researcher for data collection
Introductory Information Form In this form prepared by the researcher there are 14 questions regarding the demographic characteristics of the mother father family and child After randomization an introductory information form before peer interactive group support was administered to all adolescents in the research and control groups in a classroom of the Pediatric Outpatient Clinic where the study was conducted
Childrens Quality of Life Scale - PedsQL 13-18 age group The quality of life scale for children was developed by Varni et al 1999 to measure the quality of life of children and adolescents aged 2-18 years The internal consistency coefficient Cronbachs alpha of the section prepared for children of the scale developed by Varni et al Was found to be 093 Memik et al 2007 conducted a study on the validity and reliability of the adolescent form of the PedsQL 13-18 years old
While the World Health Organization defines health it covers the areas of physical emotional and social functionality Scoring is made for these three areas in the scale In the scale a fourth area under the name of school functionality is questioned The psychosocial health total score PSTP is calculated by calculating the total score STP physical health total score FSTP emotional social and school functionality item scores in the scale
The Quality of Life Scale for Children PedsQL is a scale suitable for use in healthy or ill children and adolescents in settings such as schools and hospitals The scale consists of 23 items in total The scale is in the form of a 5-point Likert scale and is scored between 0-4 The items are scored between 0-100 The scale gives 100 points for never answer rarely 75 points for its answer sometimes 50 points for its answer often 25 points for its answer and almost always 0 points for its answer The Turkish validity and reliability study of the PedsQL for the 13-18 age group was conducted by Memik et al 2007 The internal consistency coefficient Cronbachs alpha of the form prepared for adolescents in the study of Memik et al Was found to be 082
Friendship Qualities Scale The friendship qualities scale aims to evaluate the relationships of 10-18 year old children and adolescents with their best friends The scale was created by Bukowski et al 1994 The internal consistency coefficients Cronbachs alpha according to the sub-dimensions of the scale were 072 conflict 068 proximity 076 help 081 and protection found to be 058 The Turkish validity and reliability study of the scale was conducted by Erkan Atik et al 2014 Participants included in the study are secondary and high school students The internal consistency coefficient of the whole scale in the study of Erkan Atik et al Was found to be 085 The scale includes 22 items and five sub-dimensions The scale is graded from 1 to 5 1 is not right for your friendship 2 may be correct 3 is usually correct 4 is very correct 5 is completely correct The sub-dimensions of the scale are togetherness conflict assistance protection and closeness Togetherness sub-dimension items 1 2 3 and 4 conflict sub-dimension 567 and 8 items help sub-dimension 9101112 and 13 items protection sub-dimension 141516 and 17th items proximity sub-dimension is calculated by evaluating items 18192021 and 22 All items in the conflict sub-dimension of the scale are calculated by reverse coding The scores that can be obtained vary between 4-20 in the Togetherness Conflict and Protection sub-dimensions and 5-25 in the Assistance and Proximity sub-dimensions If the scale score to be obtained from both the total score and the sub-dimensions is high this is considered as positive peer relationships
Coping Scale for Adolescents KIDCOPE The scale which was created by Spirito et al 1988 under the name of KIDCOPE multidimensional coping strategies for children scale consists of two forms for children 5-13 years old and adolescents 13-18 years The internal consistency coefficient Cronbachs alpha of the scale was 062 The Coping Scale for Adolescents consists of 11 items in total This scale includes ten coping strategies These strategies include social distancing distraction desiring thinking problem solving withdrawal cognitive restructuring social support emotion regulation self-criticism and blaming others
The 10 strategies included in KIDCOPE are distraction played a game to watch or forget TV withdrawal left alone desiresing thinking wanted to be able to do things differently self-criticism blamed myself blaming others blaming someone else for causing the problem problem solving I tried to solve the problem by thinking about the answers emotion regulation tried to calm myself or yelled screamed cognitive restructuring tried to see the good side of things social support tried to feel better by spending time with family or friends and social distancing I didnt want to spend time with my family or friends The 10 strategies included in KIDCOPE are distraction played a game to watch or forget TV withdrawal left alone desiresing thinking wanted to be able to do things differently self-criticism blamed myself blaming others blaming someone else for causing the problem problem solving I tried to solve the problem by thinking about the answers emotion regulation tried to calm myself or yelled screamed cognitive restructuring tried to see the good side of things social support tried to feel better by spending time with family or friends and social distancing I didnt want to spend time with my family or friends In the implementation phase of the study a classroom belonging to the Child Health and Diseases Polyclinic of Afyonkarahisar Health Sciences University Faculty of Medicine Hospital was used All sessions in the research were held in this classroom The sessions lasted an average of 90 minutes in two 45-minute sections Gluten-free products were presented during the 20-minute break between sessions During the break adolescents were given the opportunity to interact with each other by chatting The pre-test application of the introductory information form and scale forms of all the participants in the research group was applied at the beginning of the first session and the post-test application at the end of the last session which was the sixth session The pre-test application of the participants included in the control group was applied on the same day separately from the research group and the post-test application only scales was applied in the same classroom at the end of all sessions
Research Group Interactive peer group support was implemented for 3 months one week apart A total of 6 sessions were held with the research group Group meetings were planned to be held at the weekend in order to prevent adolescents attendance at school However as the data collection phase is in the summer and schools are closed the sessions were held on weekdays and bi-weekly The adolescents in the study group were reached by phone before each session One day before the session all participants were sent a text message informing the meeting and its place and time and they were invited Each session lasted 15 hours on average
The contents of the first and second sessions of the research were prepared beforehand However the contents of the third fourth fifth and sixth sessions were arranged after the first two sessions Table of contents of the 6 sessions held is presented in Table 3
In the sessions all participants were asked questions regarding the target determined for the session By creating a discussion environment based on these questions it was ensured that the participants shared their problems and solutions with each other The responses of the participants to the questions were noted and reported by the researcher
Control Group No peer interactive group support was provided to the control group In the control group in a classroom belonging to the Universitys Child Health and Diseases Polyclinic where the study was conducted the Introductory Information Form the Quality of Life Scale for Children the Friendship Qualities Scale the Adolescent Coping Scale were applied after the adolescents and parents were informed about the subject of the study and written permission was obtained Three months later the Adolescents in the control group were administered the Quality of Life Scale for Children Friendship Qualities Scalee and the Adolescent Coping Scale
The adolescents in the control group were not informed about the routine education they received from the hospital during the study A separate training meeting was held for the control group on 11102018 after all sessions of the peer interactive group support of the study were completed The training lasted about one hour in the classroom of the Universitys Child Health and Diseases Polyclinic The definition symptoms and signs of celiac disease treatment and dietary rules were discussed in the training content At the end of the meeting an information booklet titled Living with Celiacs was given
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None