Multiple Chronic ConditionsEmCogNCT05778630
Emotions and Cognitions in Pediatric Chronic Physical Conditions
A study testing Focus group meetings and Individual interviews in people with Multiple Chronic Conditions, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multiple Chronic Conditions
- What is being tested?
- Focus group meetings and Individual interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Mareike Kaemmerer
Brussels, 1000
Mareike Kaemmerer, mareike.kaemmerer@uclouvain.be
About this study
Official title: Emotions and Cognitions in Pediatric Chronic Physical Conditions - the Creation and Implementation of a Psychological Intervention
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).
Read the 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.
- Conditions
- Multiple Chronic Conditions
- Being tested
- Focus group meetings, Individual interviews
- Keywords
- pediatric, chronic disease, intervention, emotion, cognition
- Medical subject headings
- Multiple Chronic Conditions, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group meetingsOther
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.
Individual interviewsOther
Individual qualitative interviews (semi-directive), conducted by one or two study facilitators.
| Study group | Role | What they receive |
|---|---|---|
| Group A. Focus group | Other | Individuals will participate in one or several, semi-structured focus group meetings. Receives: Other: Focus group meetings; Other: Individual interviews |
| Group B. Individual | Other | Individuals will participate in a semi-structured qualitative interview. Receives: Other: Focus group meetings; Other: Individual interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: October 2021-December 2024
Secondary outcomes (1)
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.
Measured: October 2021-December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Oct 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Multiple Chronic ConditionsStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Individual qualitative interviews. Focus group meetings.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Moniotte, Principal investigator, Cliniques universitaires Saint-Luc UCLouvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778630
- Sponsor's protocol ID
- 2021/14JUI/269
- Other IDs
- 813546
- Acronym
- EmCog
- Status last verified
- Mar 2023
- First submitted
- 21 Sep 2021
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22059621McNally 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.
PubMed 20215458Marshall, P., de Salas, K., & Mckay, J. (2006). Action research in practice: Balancing the dual imperatives. ACIS 2006 Proceedings - 17th Australasian Conference on Information Systems.
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.
PubMed 22585190Luminet, O. (2008). Psychologie des émotions (2nd edition). De Boeck.
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
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.
PubMed 30578633Beale 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.
PubMed 16162841Plante 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.
PubMed 11553698Hysing 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.
PubMed 17683450Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotions and Cognitions in Pediatric Chronic Physical Conditions - the Creation and Implementation of a Psychological Intervention
- ClinicalTrials.gov ID
- NCT05778630
- Acronym / sponsor ID
- EmCog / 2021/14JUI/269
- Conditions
- Multiple Chronic Conditions
- Keywords
- pediatric, chronic disease, intervention, emotion, cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individual qualitative interviews. Focus group meetings.
| Arm | Type | Receives |
|---|---|---|
| Group A. Focus group | Other | Other: Focus group meetings, Other: Individual interviewsIndividuals will participate in one or several, semi-structured focus group meetings. |
| Group B. Individual | Other | Other: Focus group meetings, Other: Individual interviewsIndividuals will participate in a semi-structured qualitative interview. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus group meetingsFocus 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. | Other | Group A. Focus group, Group B. Individual |
| Individual interviewsIndividual qualitative interviews (semi-directive), conducted by one or two study facilitators. | Other | Group A. Focus group, Group B. Individual |
Primary outcome
Interview data outcomes
Time frame: October 2021-December 2024
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).
1 secondary outcome
Interview data outcomes and systematic review results
Time frame: October 2021-December 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Background: PubMed 22059621Sansom-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.
- Background: PubMed 20215458McNally 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.
- BackgroundMarshall, 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: PubMed 22585190Lahaye 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.
- BackgroundLuminet, O. (2008). Psychologie des émotions (2nd edition). De Boeck.
- BackgroundNef, 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: PubMed 30578633Thabrew 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.
- Background: PubMed 16162841Beale 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.
- Background: PubMed 11553698Plante 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.
- Background: PubMed 17683450Hysing 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.
- BackgroundBraun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Moniotte principal investigator
Cliniques universitaires Saint-Luc UCLouvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus group meetings and Individual interviews in people with Multiple Chronic Conditions, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mareike Kaemmerer (+33766858444, mareike.kaemmerer@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interview data outcomes (time frame: October 2021-December 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05778630, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.