Support for Adolescents With Celiac Disease
Peer-Interaction Group Support in Adolescents With Celiac Disease: A Randomized Controlled Trial
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2018
CompletedFirst Submitted
Initial submission to the registry
August 10, 2020
CompletedFirst Posted
Study publicly available on registry
September 1, 2020
CompletedSeptember 3, 2020
August 1, 2020
3 months
August 10, 2020
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
12 weeks
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.
12 weeks
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.
12 weeks
Study Arms (2)
PEER-INTERACTION GROUP SUPPORT
EXPERIMENTALAll 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.
routine health care- control group
EXPERIMENTALPeer interactive group support was not provided to the control group.
Interventions
* 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
* 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
* 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)
* 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)
* 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
* 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
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.
Eligibility Criteria
You may qualify if:
- Must have had celiac disease for more than a year
- Must be between 13-18 years old
You may not qualify if:
- Another chronic disease
- Psychiatric illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Selcuk University Aksehir Kadir Yallagöz Health School.
Konya, 42550, Turkey (Türkiye)
Related Publications (25)
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.
PMID: 22157137BACKGROUNDde 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.
PMID: 21598063BACKGROUNDErrichiello 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.
PMID: 19644397BACKGROUNDFasano 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.
PMID: 23252527BACKGROUNDHill 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.
PMID: 15625418BACKGROUNDKautto 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.
PMID: 25191610BACKGROUNDLebwohl 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.
PMID: 28760445BACKGROUNDNewton 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.
PMID: 22549889BACKGROUNDRose 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.
PMID: 23516989BACKGROUNDSevinc 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.
PMID: 27886806BACKGROUNDBiagetti 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.
PMID: 24225846RESULTBongiovanni 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.
PMID: 20156892RESULTCai 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.
PMID: 28226183RESULTChauhan 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.
PMID: 20532683RESULTCreedy 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.
PMID: 15729797RESULTEisenberg SA, Shen BJ, Schwarz ER, Mallon S. Avoidant coping moderates the association between anxiety and patient-rated physical functioning in heart failure patients. J Behav Med. 2012 Jun;35(3):253-61. doi: 10.1007/s10865-011-9358-0. Epub 2011 Jun 10.
PMID: 21660588RESULTJaser SS, White LE. Coping and resilience in adolescents with type 1 diabetes. Child Care Health Dev. 2011 May;37(3):335-42. doi: 10.1111/j.1365-2214.2010.01184.x. Epub 2010 Dec 9.
PMID: 21143270RESULTKlein DM, Turvey CL, Pies CJ. Relationship of coping styles with quality of life and depressive symptoms in older heart failure patients. J Aging Health. 2007 Feb;19(1):22-38. doi: 10.1177/0898264306296398.
PMID: 17215200RESULTKolsteren MM, Koopman HM, Schalekamp G, Mearin ML. Health-related quality of life in children with celiac disease. J Pediatr. 2001 Apr;138(4):593-5. doi: 10.1067/mpd.2001.111504.
PMID: 11295729RESULTMackner LM, Ruff JM, Vannatta K. Focus groups for developing a peer mentoring program to improve self-management in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2014 Oct;59(4):487-92. doi: 10.1097/MPG.0000000000000473.
PMID: 24979662RESULTScheel A, Beaton A, Okello E, Longenecker CT, Otim IO, Lwabi P, Sable C, Webel AR, Aliku T. The impact of a peer support group for children with rheumatic heart disease in Uganda. Patient Educ Couns. 2018 Jan;101(1):119-123. doi: 10.1016/j.pec.2017.07.006. Epub 2017 Jul 11.
PMID: 28716486RESULTSmeulders ES, van Haastregt JC, Ambergen T, Uszko-Lencer NH, Janssen-Boyne JJ, Gorgels AP, Stoffers HE, Lodewijks-van der Bolt CL, van Eijk JT, Kempen GI. Nurse-led self-management group programme for patients with congestive heart failure: randomized controlled trial. J Adv Nurs. 2010 Jul;66(7):1487-99. doi: 10.1111/j.1365-2648.2010.05318.x. Epub 2010 May 21.
PMID: 20492026RESULTSnead K, Ackerson J, Bailey K, Schmitt MM, Madan-Swain A, Martin RC. Taking charge of epilepsy: the development of a structured psychoeducational group intervention for adolescents with epilepsy and their parents. Epilepsy Behav. 2004 Aug;5(4):547-56. doi: 10.1016/j.yebeh.2004.04.012.
PMID: 15256193RESULTStewart M, Letourneau N, Masuda JR, Anderson S, McGhan S. Impacts of online peer support for children with asthma and allergies: It just helps you every time you can't breathe well". J Pediatr Nurs. 2013 Sep-Oct;28(5):439-52. doi: 10.1016/j.pedn.2013.01.003. Epub 2013 Feb 9.
PMID: 23398896RESULTTrivedi RB, Blumenthal JA, O'Connor C, Adams K, Hinderliter A, Dupree C, Johnson K, Sherwood A. Coping styles in heart failure patients with depressive symptoms. J Psychosom Res. 2009 Oct;67(4):339-46. doi: 10.1016/j.jpsychores.2009.05.014.
PMID: 19773027RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hicran Çavuşoğlu
Hacettepe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecturer, Dr.(Nursing Department)
Study Record Dates
First Submitted
August 10, 2020
First Posted
September 1, 2020
Study Start
June 22, 2018
Primary Completion
September 6, 2018
Study Completion
October 11, 2018
Last Updated
September 3, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share