Emotions and Cognitions in Pediatric Chronic Physical Conditions

NCT05778630 | Unknown

• 2 other identifiers: 2021/14JUI/269813546
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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:

1. 1.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.
2. 2.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).

Conditions

Multiple Chronic Conditions

Keywords

pediatric; chronic disease; intervention; emotion; cognition

Outcome Measures

Primary Outcomes (1)

• 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).

  October 2021-December 2024

Secondary Outcomes (1)

• Interview data outcomes and systematic review results

  October 2021-December 2024

Study Arms (2)

Group A. Focus group

OTHER

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

Other: Focus group meetings; Other: Individual interviews

Group B. Individual

OTHER

Individuals will participate in a semi-structured qualitative interview.

Other: Focus group meetings; Other: Individual interviews

Interventions

Focus group meetings OTHER

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.

Group A. Focus group; Group B. Individual

Individual interviews OTHER

Individual qualitative interviews (semi-directive), conducted by one or two study facilitators.

Group A. Focus group; Group B. Individual

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Mareike Kaemmerer

Brussels, 1000, Belgium

RECRUITING

Related Publications (11)

• 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.

  PMID: 22059621 BACKGROUND

• 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.

  PMID: 20215458 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22585190 BACKGROUND

• Luminet, O. (2008). Psychologie des émotions (2nd edition). De Boeck.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30578633 BACKGROUND

• 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.

  PMID: 16162841 BACKGROUND

• 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.

  PMID: 11553698 BACKGROUND

• 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.

  PMID: 17683450 BACKGROUND

• Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa

  BACKGROUND

MeSH Terms

Conditions

Multiple Chronic Conditions; Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stéphane Moniotte

  Cliniques universitaires Saint-Luc UCLouvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mareike Kaemmerer

CONTACT

+33766858444; mareike.kaemmerer@uclouvain.be

Stéphane Moniotte

CONTACT

+ 32 2 764 13 80; stephane.moniotte@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individual qualitative interviews. Focus group meetings.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: March 21, 2023
• Study Start: October 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)