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Celiac Disease in ChildrenNCT04533776

Support for Adolescents With Celiac Disease

A study testing Celiac Disease Definition, Symptoms and Treatment, Difficulties Due to Celiac Disease and Gluten Free Diet in Celiac Disease in people with Celiac Disease in Children, run by Melike Taşdelen Baş at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 18 years
Conditions the study is for
Celiac Disease in Children
What is being tested?
Celiac Disease Definition, Symptoms and Treatment, Difficulties Due to Celiac Disease and Gluten Free Diet in Celiac Disease
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Jun 2018to 11 Oct 2018
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 13 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Must have had celiac disease for more than a year
  • Must be between 13-18 years old

Who cannot join

  • Another chronic disease
  • Psychiatric illness

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Selcuk University Aksehir Kadir Yallagöz Health School.

    Konya, 42550

Other trials in Turkey (Türkiye)

About this study

Official title: Peer-Interaction Group Support in Adolescents With Celiac Disease: A Randomized Controlled Trial

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.

Read the 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 09:00 and 17:00 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.

Children's 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 (Cronbach's alpha) of the section prepared for children of the scale developed by Varni et al. Was found to be 0.93. 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 (Cronbach's alpha) of the form prepared for adolescents in the study of Memik et al. Was found to be 0.82.

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 (Cronbach's alpha) according to the sub-dimensions of the scale were: 0.72; conflict: 0.68; proximity: 0.76; help: 0.81; and protection: found to be 0.58. 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 0.85. 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 5,6,7 and 8 items, help sub-dimension 9,10,11,12 and 13 items, protection sub-dimension 14,15,16 and 17th items, proximity sub-dimension is calculated by evaluating items 18,19,20,21 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 (Cronbach's alpha) of the scale was 0.62. 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 didn't 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 didn't 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 1.5 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 University's 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 11.10.2018, 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 University's 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.

Being tested
Celiac Disease Definition, Symptoms and Treatment, Difficulties Due to Celiac Disease, Gluten Free Diet in Celiac Disease, Difficulties Related to Disease in School and Social Life, Celiac Disease and Its Effects on Acamdemic Success Peer Relations
Keywords
Celiac Disease, Adolescent, Quality of Life, Friendship Relations, Coping, Nursing Care
Medical subject headings
Celiac Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Celiac Disease Definition, Symptoms and TreatmentBehavioural

    • Adolescents share their knowledge about the disease
    • Emphasizing the definition and symptoms of celiac disease
    • Discussion of the treatment of celıac disease Expression Question-Answer Discussion Summarizing
  • Difficulties Due to Celiac DiseaseBehavioural

    • Determining what experience living with celiac is fot the patient (What do I think about the disease, how do I feel about the disease,how do I perceive the disease, how does the disease affect me)
    • Determining the difficulties encountered in Daily life due to illness (How do I deal with difficulties)
    • Determining how the disease affects life Expression Question-Answer Discussion Summarizing
  • Gluten Free Diet in Celiac DiseaseBehavioural

    • Evaluating dietary information
    • Identifying the difficulties in diet therapy Expression Question-Answer Discussion Summarizing Case Study Presentation (Transfer of life experience of an individual who is 22 years old with celiac disease)
  • Difficulties Related to Disease in School and Social LifeBehavioural

    • Assessment of difficulties encountered in school and social life
    • Evaluation of the solution suggestions fort he difficulties encountered Expression Question-Answer Discussion Summarizing Örnek Olay Sunumu (Transfer of life of experience of a 23 years old dietician with celiac disease)
  • Celiac Disease and Its Effects on Acamdemic Success Peer RelationsBehavioural

    • Evaluation of the effects of the disease on academic success
    • Evaluation of the effects of the disease on peer relationships in the school enviroment
    • Difficulties experienced in peer relations and evaluation of relationships (exclusion) Expression Question-Answer Discussion Summarizing
  • Celiac Diseae anf Future GoalsBehavioural

    • General summary of all sessions so far
    • Summarizing the topics discussed in the previous session
    • Evaluating the future goals of the participants Expression Question-Answer Discussion Summarizing
  • No Intervention: routine health care- control groupOther

    Peer interactive group support was not provided to the control group. After all the sessions of the peer interactive group support of the study were completed, a separate training meeting was held for the control group.

Study groups in NCT04533776
Study groupRoleWhat they receive
PEER-INTERACTION GROUP SUPPORTExperimentalAll the sessions of the research took place in a classroom in the hospital. The sessions lasted an average of 90 minutes with two 45-minute sections. During the break, which lasted about 20 minutes, gluten-free products were offered. During the break, adolescents were given the opportunity to chat and interact with each other. Peer interactive group support was implemented for 3 months with an interval of one week. A total of 6 sessions were held with the study group. Adolescents in the study group were contacted by phone before each session. The day before the session, a text message was sent to all participants informing the location and time of the meeting. The contents of the first and second sessions in relation to the study were created beforehand. However, contents of the third, fourth, fifth and sixth sessions were prepared after the first two sessions.
Receives: Behavioral: Celiac Disease Definition, Symptoms and Treatment; Behavioral: Difficulties Due to Celiac Disease; Behavioral: Gluten Free Diet in Celiac Disease; Behavioral: Difficulties Related to Disease in School and Social Life; Behavioral: Celiac Disease and Its Effects on Acamdemic Success Peer Relations; Behavioral: Celiac Diseae anf Future Goals
routine health care- control groupExperimentalPeer interactive group support was not provided to the control group.
Receives: Other: No Intervention: routine health care- control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life 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. It is thought that the higher the total score for PedsQL, the better the health-related quality of life.

    Measured: 12 weeks

  2. Friendship Qualities Scale

    Friendship Qualities Scale The Friendship Qualities Scale aims to evaluate the relationship of children and adolescents in the 10-18 age group with their best friends. 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.

    Measured: 12 weeks

  3. Coping Scale (KIDCOPE)

    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 scores to be scored range from 0-12 for active and avoidant coping, and 0-9 points for negative coping. A higher score indicates that the assessed coping approach is used more.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2020
  2. Study start22 Jun 2018
  3. Primary completion6 Sep 2018
  4. Study completion11 Oct 2018

Resources

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
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04533776
Sponsor's protocol ID
2018/08-24 (KA-180047)
Status last verified
Aug 2020
First submitted
10 Aug 2020
Last updated
3 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Al-sheyab N, Gallagher R, Crisp J, Shah S. Peer-led education for adolescents with asthma in Jordan: a cluster-randomized controlled trial. Pediatrics. 2012 Jan;129(1):e106-12. doi: 10.1542/peds.2011-0346. Epub 2011 Dec 12.

    PubMed 22157137
  • de Lorenzo CM, Xikota JC, Wayhs MC, Nassar SM, de Souza Pires MM. Evaluation of the quality of life of children with celiac disease and their parents: a case-control study. Qual Life Res. 2012 Feb;21(1):77-85. doi: 10.1007/s11136-011-9930-7. Epub 2011 May 20.

    PubMed 21598063
  • Errichiello S, Esposito O, Di Mase R, Camarca ME, Natale C, Limongelli MG, Marano C, Coruzzo A, Lombardo M, Strisciuglio P, Greco L. Celiac disease: predictors of compliance with a gluten-free diet in adolescents and young adults. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):54-60. doi: 10.1097/MPG.0b013e31819de82a.

    PubMed 19644397
  • Fasano A, Catassi C. Clinical practice. Celiac disease. N Engl J Med. 2012 Dec 20;367(25):2419-26. doi: 10.1056/NEJMcp1113994. No abstract available.

    PubMed 23252527
  • Hill ID, Dirks MH, Liptak GS, Colletti RB, Fasano A, Guandalini S, Hoffenberg EJ, Horvath K, Murray JA, Pivor M, Seidman EG; North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. Guideline for the diagnosis and treatment of celiac disease in children: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2005 Jan;40(1):1-19. doi: 10.1097/00005176-200501000-00001.

    PubMed 15625418
  • Kautto E, Ryden PJ, Ivarsson A, Olsson C, Norstrom F, Hogberg L, Carlsson A, Hagfors L, Hornell A. What happens to food choices when a gluten-free diet is required? A prospective longitudinal population-based study among Swedish adolescent with coeliac disease and their peers. J Nutr Sci. 2014 Feb 13;3:e2. doi: 10.1017/jns.2013.24. eCollection 2014.

    PubMed 25191610
  • Lebwohl B, Sanders DS, Green PHR. Coeliac disease. Lancet. 2018 Jan 6;391(10115):70-81. doi: 10.1016/S0140-6736(17)31796-8. Epub 2017 Jul 28.

    PubMed 28760445
  • Newton KP, Singer SA. Celiac disease in children and adolescents: special considerations. Semin Immunopathol. 2012 Jul;34(4):479-96. doi: 10.1007/s00281-012-0313-0. Epub 2012 May 2.

    PubMed 22549889
  • Rose C, Howard R. Living with coeliac disease: a grounded theory study. J Hum Nutr Diet. 2014 Feb;27(1):30-40. doi: 10.1111/jhn.12062. Epub 2013 Mar 21.

    PubMed 23516989
  • Sevinc E, Cetin FH, Coskun BD. Psychopathology, quality of life, and related factors in children with celiac disease. J Pediatr (Rio J). 2017 May-Jun;93(3):267-273. doi: 10.1016/j.jped.2016.06.012. Epub 2016 Nov 23.

    PubMed 27886806
  • Biagetti C, Naspi G, Catassi C. Health-related quality of life in children with celiac disease: a study based on the Critical Incident Technique. Nutrients. 2013 Nov 12;5(11):4476-85. doi: 10.3390/nu5114476.

    PubMed 24225846
  • Bongiovanni TR, Clark AL, Garnett EA, Wojcicki JM, Heyman MB. Impact of gluten-free camp on quality of life of children and adolescents with celiac disease. Pediatrics. 2010 Mar;125(3):e525-9. doi: 10.1542/peds.2009-1862. Epub 2010 Feb 15.

    PubMed 20156892
  • Cai RA, Holt RIG, Casdagli L, Viner RM, Thompson R, Barnard K, Christie D. Development of an acceptable and feasible self-management group for children, young people and families living with Type 1 diabetes. Diabet Med. 2017 Jun;34(6):813-820. doi: 10.1111/dme.13341.

    PubMed 28226183
  • Chauhan JC, Kumar P, Dutta AK, Basu S, Kumar A. Assessment of dietary compliance to gluten free diet and psychosocial problems in Indian children with celiac disease. Indian J Pediatr. 2010 Jun;77(6):649-54. doi: 10.1007/s12098-010-0092-3. Epub 2010 Jun 8.

    PubMed 20532683
  • Creedy D, Collis D, Ludlow T, Cosgrove S, Houston K, Irvine D, Fraser J, Moloney S. Development and evaluation of an intensive intervention program for children with a chronic health condition: a pilot study. Contemp Nurse. 2004 Dec-2005 Jan;18(1-2):46-56. doi: 10.5172/conu.18.1-2.46.

    PubMed 15729797

Questions about this trial

What is this clinical trial studying?

A study testing Celiac Disease Definition, Symptoms and Treatment, Difficulties Due to Celiac Disease and Gluten Free Diet in Celiac Disease in people with Celiac Disease in Children, run by Melike Taşdelen Baş 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 2 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: finished, as of the sponsor's last update on 3 Sep 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Quality of Life Scale (time frame: 12 weeks). The study lists 3 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 NCT04533776, which also lists 25 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 3 Sep 2020.

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