NCT04533776

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

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

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

Study Start

First participant enrolled

June 22, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 10, 2020

Last Update Submit

September 1, 2020

Conditions

Keywords

Celiac DiseaseAdolescentQuality of LifeFriendship RelationsCopingNursing Care

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

EXPERIMENTAL

All 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.

Behavioral: Celiac Disease Definition, Symptoms and TreatmentBehavioral: Difficulties Due to Celiac DiseaseBehavioral: Gluten Free Diet in Celiac DiseaseBehavioral: Difficulties Related to Disease in School and Social LifeBehavioral: Celiac Disease and Its Effects on Acamdemic Success Peer RelationsBehavioral: Celiac Diseae anf Future Goals

routine health care- control group

EXPERIMENTAL

Peer interactive group support was not provided to the control group.

Other: No Intervention: routine health care- 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

PEER-INTERACTION GROUP SUPPORT

* 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

PEER-INTERACTION GROUP SUPPORT

* 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)

PEER-INTERACTION GROUP SUPPORT

* 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)

PEER-INTERACTION GROUP SUPPORT

* 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

PEER-INTERACTION GROUP SUPPORT

* 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-INTERACTION GROUP SUPPORT

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.

routine health care- control group

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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)

Location

Related Publications (25)

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    PMID: 19644397BACKGROUND
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    PMID: 23252527BACKGROUND
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    PMID: 15625418BACKGROUND
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    PMID: 25191610BACKGROUND
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    PMID: 28760445BACKGROUND
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    PMID: 22549889BACKGROUND
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    PMID: 23516989BACKGROUND
  • 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.

    PMID: 27886806BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

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  • Eisenberg 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.

  • Jaser 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.

  • Klein 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.

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  • Mackner 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.

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  • Smeulders 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.

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MeSH Terms

Conditions

Celiac Disease

Interventions

TherapeuticsDiet, Gluten-FreeSchools

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaNon-Medical Public and Private Facilities

Study Officials

  • Hicran Çavuşoğlu

    Hacettepe University

    STUDY DIRECTOR

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

Locations