search
Back to results

Emotions and Cognitions in Pediatric Chronic Physical Conditions (EmCog)

Primary Purpose

Multiple Chronic Conditions

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Focus group meetings
Individual interviews
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Chronic Conditions focused on measuring pediatric, chronic disease, intervention, emotion, cognition

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: The participant is a health care professional in the domain of pediatric chronic diseases or parents/family members/tutors of a child with CPC, aged 8-12 years OR is in regular contact with children with a chronic physical condition who are between 8 and 12-years-old. speak fluently French Exclusion Criteria: Health care professionals who are not in regular contact with children, 8 to 12 years- old, with a chronic physical condition Parents with a child with CPC who is not 8 to 12 years old Participants who do not speak French

Sites / Locations

  • Mareike KaemmererRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A. Focus group

Group B. Individual

Arm Description

Individuals will participate in one or several, semi-structured focus group meetings.

Individuals will participate in a semi-structured qualitative interview.

Outcomes

Primary Outcome Measures

Interview data outcomes
Interview questions will explore: 1) emotional and cognitive difficulties and resources of children with CPC, 2) emotional and cognitive needs of children with CPC. Audio data from semi-structured group meetings and semi-structured individual interviews will be transcribed and analysed with thematic analysis (Braun & Clarke, 2006).

Secondary Outcome Measures

Interview data outcomes and systematic review results
Narrative comparison of emerged themes from the thematic analysis of qualitative interview data, to results of the systematic literature review.

Full Information

First Posted
September 21, 2021
Last Updated
March 9, 2023
Sponsor
Université Catholique de Louvain
search

1. Study Identification

Unique Protocol Identification Number
NCT05778630
Brief Title
Emotions and Cognitions in Pediatric Chronic Physical Conditions
Acronym
EmCog
Official Title
Emotions and Cognitions in Pediatric Chronic Physical Conditions - the Creation and Implementation of a Psychological Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Children living with a chronic physical condition (CPC) are more likely than their peers without a disease to develop psychological difficulties or disorders (Hysing et al., 2007). To prevent or treat these difficulties and disorders, many psychotherapeutic approaches have been developed and tested. Most of them follow a categorical approach, based on a global diagnosis (e.g., Moreira et al., 2013). Few interventions are conducted from a processual perspective (Nef et al., 2012) studying underlying mechanisms of psychological functioning. Emotions and cognitions represent such underlying processes and play an important role in many psychopathological disorders. These processes can weaken but also protect a child from developing psychological difficulties, depending on whether they are effective or not (Gipson et al., 2006; Hysing et al., 2007; Lahaye et al., 2011). The present research project aims to identify a psychological intervention that builds on knowledge of emotional and cognitive processes, considered as protective and risk factors, to prevent/treat psychological difficulties. The project will be conducted in two parts: The first phase aims to better understand the action mechanisms of psychological interventions, focused on emotional and cognitive difficulties of children with CPCs. First, a systematic review will identify recent literature which reports the efficacy of psychological interventions which focused on emotional and cognitive processes. Second, interviews with experts (e.g., pediatricians, psychiatrists, psychologists, nurses, educators) in the field of CPCs and with parents/families of children with CPCs will be conducted. Individual and focus group meetings will be organized, with the aim of identifying the needs of children, based on clinical and practical knowledge and experience. A third phase will consist of the selection of an intervention that will be based on the results of the first two phases. In the second part (not yet registered), the selected intervention will be set up for a feasibility study (Bowen et al., 2009). For this, a small sample of children will participate in the intervention. Participants will be randomly allocated to an intervention group and a control group. The control group will participate in an alternative intervention (e.g., information on chronic diseases). The exact content of the intervention and its form (number of sessions, duration etc.) will be determined by the focus group. The intervention's efficacy will be evaluated (evaluation of emotional and cognitive processes as well as psychological and physiological health), using a mixed method approach. The results will be analyzed and discussed with the focus group. Limitations and perspectives will be formulated to allow for possible transfer of the intervention for future use or to other areas of psychology (Durlak & DuPre, 2008).
Detailed Description
The research project will be conducted as a non-medical intervention study, based on a mixed method and action-research principles (Bradbury & Lifvergren, 2016; Ivankova & Wingo, 2018; Malengreaux et al., 2020; Marshall et al., 2006). It will include a systematic literature review, quantitative (standardized questionnaires, self and hetero-reports) and qualitative measures (dialogues and discussions, semi-directed interviews, audio-recordings, observations, written reports). The effectiveness study of PART II of the research project will be carried out as randomized controlled trial but is not described in this registration. PART 1 Phase I.a: A systematic literature review is conducted by all investigators (researchers) in order to better understand action mechanisms of psychological interventions for children with chronic diseases (registered in PROSPERO: CRD42021233505). Phase I.b: Individual semi-structured qualitative interviews will be conducted by one or two investigators to explore the following questions: Which are emotional and cognitive difficulties and resources in children with CPC? Which are the emotional and cognitive needs of children with CPC? How are these/can these be addressed? One or several focus groups will be created. They will be composed of different experts in the domain of CPCs (health care professionals, families, researchers, etc.). Per group, one or several meetings will be organized, depending on participants' availabilities. The meetings will be conducted by one or two investigators who will use semi-structured interview techniques to explore the following questions: Which are emotional and cognitive difficulties and resources in children with CPC? Which are the emotional and cognitive needs of children with CPC? How are these/can these be addressed? PART II will consist of a feasibility and an effectiveness study of the intervention. For both studies, the selected intervention will be implemented, based on scientific, rigorous methods, and be evaluated with different quantitative and qualitative measures. PART II will rely on PART I. Thus, it will be described in another registration after completion of PART I.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chronic Conditions
Keywords
pediatric, chronic disease, intervention, emotion, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individual qualitative interviews. Focus group meetings.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A. Focus group
Arm Type
Other
Arm Description
Individuals will participate in one or several, semi-structured focus group meetings.
Arm Title
Group B. Individual
Arm Type
Other
Arm Description
Individuals will participate in a semi-structured qualitative interview.
Intervention Type
Other
Intervention Name(s)
Focus group meetings
Intervention Description
Focus group meetings with different experts in the domain of CPCs (health care professionals) and/or parents or family members of a child with CPC. Focus group meetings will be facilitated by one or two study investigators. Group discussions will be audio-recorded.
Intervention Type
Other
Intervention Name(s)
Individual interviews
Intervention Description
Individual qualitative interviews (semi-directive), conducted by one or two study facilitators.
Primary Outcome Measure Information:
Title
Interview data outcomes
Description
Interview questions will explore: 1) emotional and cognitive difficulties and resources of children with CPC, 2) emotional and cognitive needs of children with CPC. Audio data from semi-structured group meetings and semi-structured individual interviews will be transcribed and analysed with thematic analysis (Braun & Clarke, 2006).
Time Frame
October 2021-December 2024
Secondary Outcome Measure Information:
Title
Interview data outcomes and systematic review results
Description
Narrative comparison of emerged themes from the thematic analysis of qualitative interview data, to results of the systematic literature review.
Time Frame
October 2021-December 2024

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: The participant is a health care professional in the domain of pediatric chronic diseases or parents/family members/tutors of a child with CPC, aged 8-12 years OR is in regular contact with children with a chronic physical condition who are between 8 and 12-years-old. speak fluently French Exclusion Criteria: Health care professionals who are not in regular contact with children, 8 to 12 years- old, with a chronic physical condition Parents with a child with CPC who is not 8 to 12 years old Participants who do not speak French
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mareike Kaemmerer
Phone
+33766858444
Email
mareike.kaemmerer@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane Moniotte
Phone
+ 32 2 764 13 80
Email
stephane.moniotte@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Moniotte
Organizational Affiliation
Cliniques universitaires Saint-Luc UCLouvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mareike Kaemmerer
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mareike Kaemmerer
Email
mareike.kaemmerer@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22059621
Citation
Sansom-Daly UM, Peate M, Wakefield CE, Bryant RA, Cohn RJ. A systematic review of psychological interventions for adolescents and young adults living with chronic illness. Health Psychol. 2012 May;31(3):380-93. doi: 10.1037/a0025977. Epub 2011 Nov 7.
Results Reference
background
PubMed Identifier
20215458
Citation
McNally K, Rohan J, Pendley JS, Delamater A, Drotar D. Executive functioning, treatment adherence, and glycemic control in children with type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1159-62. doi: 10.2337/dc09-2116. Epub 2010 Mar 9.
Results Reference
background
Citation
Marshall, P., de Salas, K., & Mckay, J. (2006). Action research in practice: Balancing the dual imperatives. ACIS 2006 Proceedings - 17th Australasian Conference on Information Systems.
Results Reference
background
PubMed Identifier
22585190
Citation
Lahaye M, Van Broeck N, Bodart E, Luminet O. Predicting quality of life in pediatric asthma: the role of emotional competence and personality. Qual Life Res. 2013 May;22(4):907-16. doi: 10.1007/s11136-012-0194-7. Epub 2012 May 15.
Results Reference
background
Citation
Luminet, O. (2008). Psychologie des émotions (2nd edition). De Boeck.
Results Reference
background
Citation
Nef, F., Phillippot, P., & Verhofstadt, L. (2012). L'approche processuelle en évaluation et intervention cliniques: une approche psychologique intégrée. Revue Francophone de CliniqueComportementale et Cognitive, 17(3). http://hdl.handle.net/2078.1/129174
Results Reference
background
PubMed Identifier
30578633
Citation
Thabrew H, Stasiak K, Hetrick SE, Donkin L, Huss JH, Highlander A, Wong S, Merry SN. Psychological therapies for anxiety and depression in children and adolescents with long-term physical conditions. Cochrane Database Syst Rev. 2018 Dec 22;12(12):CD012488. doi: 10.1002/14651858.CD012488.pub2.
Results Reference
background
PubMed Identifier
16162841
Citation
Beale IL. Scholarly literature review: Efficacy of psychological interventions for pediatric chronic illnesses. J Pediatr Psychol. 2006 Jun;31(5):437-51. doi: 10.1093/jpepsy/jsj079. Epub 2005 Sep 14.
Results Reference
background
PubMed Identifier
11553698
Citation
Plante WA, Lobato D, Engel R. Review of group interventions for pediatric chronic conditions. J Pediatr Psychol. 2001 Oct-Nov;26(7):435-53. doi: 10.1093/jpepsy/26.7.435.
Results Reference
background
PubMed Identifier
17683450
Citation
Hysing M, Elgen I, Gillberg C, Lie SA, Lundervold AJ. Chronic physical illness and mental health in children. Results from a large-scale population study. J Child Psychol Psychiatry. 2007 Aug;48(8):785-92. doi: 10.1111/j.1469-7610.2007.01755.x.
Results Reference
background
Citation
Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa
Results Reference
background

Learn more about this trial

Emotions and Cognitions in Pediatric Chronic Physical Conditions

We'll reach out to this number within 24 hrs