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| ID | Type | Description | Link |
|---|---|---|---|
| 813546 | Other Grant/Funding Number | European Union Horizon 2020 Program |
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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 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A. Focus group | Other | Individuals will participate in one or several, semi-structured focus group meetings. |
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| Group B. Individual | Other | Individuals will participate in a semi-structured qualitative interview. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | October 2021-December 2024 |
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Inclusion criteria:
The participant
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mareike Kaemmerer | Contact | +33766858444 | mareike.kaemmerer@uclouvain.be | |
| Stéphane Moniotte | Contact | + 32 2 764 13 80 | stephane.moniotte@uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Stéphane Moniotte | Cliniques universitaires Saint-Luc UCLouvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mareike Kaemmerer | Recruiting | Brussels | 1000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22059621 | Background | 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. | |
| 20215458 | 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. |
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| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Individual qualitative interviews. Focus group meetings.
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| Individual interviews | Other | Individual qualitative interviews (semi-directive), conducted by one or two study facilitators. |
|
| 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. |
| 22585190 | 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. |
| 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 |
| 30578633 | 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. |
| 16162841 | 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. |
| 11553698 | 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. |
| 17683450 | 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. |
| 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 |