Lise Laclautre

Frank PIZON, MCF HDR

Laurent GERBAUD, PU PH

Model and map, from a qualitative multi-phased protocol, the conceptions and systems of conceptions of the determinants of health and cancer expressed and perceived by schoolchildren aged 6 to 11 years. The secondary objectives are to analyze the ability to question the conceptions of children's health regardless of their age and to link conceptions and determinants to contextual factors. The informative value and complementarity of the collection tools (photo expression, QC, photo-narration) and the relevance of a mixed analysis methodology (qualitative and quantitative) in order to highlight the different determinants of health will also be studied.

Qualitative observational study of human and social sciences (SHS), multicenter, conducted with schoolchildren.

The qualitative methodology used combines the use of photographs, open questionnaires and focus groups, over very large panels, aiming at both diversity and representativeness.

* Photo expression: to identify the determinants perceived as having a positive or negative influence on one's health;
* CQR : Certainty/Question/Rumour on how to take care of one's health (health promotion input following on from school policies, i.e. PES: Politique d'Etablissements Scolaires);
* Photo narration: to identify argumentative frameworks in health and alternatives perceived as being positive or negative for one's health,
* Focus groups: to improve understanding of the rationalities built by adolescents in relation to that which determines their health.

This choice is justified by the need to explore and understand the actions from the participants' point of view.

The diversity of schools and pupils (5 classes in 4 schools in the AURA region, i.e. 320 pupils) will make it possible to obtain the data saturation required in qualitative research.

This makes it possible to consider a mixed analysis strategy, both qualitative and quantitative.

This project aims to better understand the rationalities elaborated by children and the way in which their concepts on the determinants of cancer interlink, as well as to describe the declared impact these concepts have on the decision-making regarding their health.

Determinants of Health and Cancer: Investigating the Conceptions of Children From 6 to 11 Years Old

The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.

The informative value and complementarity of the collection tools (photo The informative value are measured with collection tools (photo expression, photo-narration) and a mixed analysis methodology (qualitative and quantitative) is used in order to highlight the different determinants of health.

The informative value are measured with collection tools (photo expression, photo-narration) and a mixed analysis methodology (qualitative and quantitative) is used in order to highlight the different determinants of health.

Identify child profiles / classes / school based :• Socio-demographic data (class / age, sex, class size, number of male and female, school enrollment, class number, geographical location, priority education, team stability, health project, type of project, impression of researchers)

• Domains or designs: Individual \& collective Domains created during the qualitative analysis

Université d'Auvergne

University Hospital, Clermont-Ferrand

Neoplasms

Nervous System Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Brain Neoplasms

Fibrosis

Cystic Fibrosis

Pancreatic Diseases

Gastrointestinal Diseases

Lung Diseases

Respiratory Tract Diseases

Genetic Diseases, Inborn

Infant, Newborn, Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Newly diagnosed brain tumour patients aged between 5 and 13 years

Patients diagnosed with Cystic Fibrosis aged between 5 and 13 years

Healthy children aged between 5 and 13 years

A Kingma, PhD

There is ample evidence that children treated for a brain tumour (BT) often develop deficits in social and emotional functioning. The investigators wish to examine the cause of these deficits, i.e. the underlying neuropsychological deficit(s). The aim is to study impairment and developmental delay in social cognition (and related cognitive functions) caused by brain damage in patients treated for a BT in childhood as compared to a reference group of chronically ill children. If we can identify the specific deficits these patients experience, neuropsychological treatment and guidance can be developed to give patients the most optimal chances to live as normal as possible, to improve their quality of life (QoL) and to prevent them from developing depression and anxiety. Eventually, an intervention programme could be developed based on our results, to improve social, vocational and emotional QoL.

* Rationale: There is ample evidence that children treated for a brain tumour (BT) often develop deficits in social and emotional functioning. The investigators wish to examine the cause of these deficits, i.e. the underlying neuropsychological deficit(s). The following is expected:

  1. Children treated for a BT will perform worse than both healthy controls and patients with Cystic Fibrosis (CF) on measures of social cognition at Time 2 (3 years post diagnosis), but not at Time 1 (shortly after diagnosis, before neurotoxic treatment). The deterioration in performance will be influenced by the following adverse factors:

     1. History of cranial radiation therapy;
     2. Site of lesion in diencephalon;
     3. History of hydrocephalus and/or posterior fossa syndrome;
     4. Younger age at diagnosis.
  2. Parents and teachers will rate patients with a BT as being less socially competent and experiencing more internalizing problems than healthy controls and patients with CF at Time 2, but not at Time 1.
  3. Performance on tests of social cognition will be positively related to executive functions at Time 1 and 2.
  4. Performance on tests of social cognition will be positively related to parent and teacher reports of social competence and environmental biographic factors (parental education and occupation) at Time 1 and 2.
* Objective: To study impairment and developmental delay in social cognition (and related cognitive functions) caused by brain damage in patients treated for a BT in childhood as compared to a reference group of chronically ill children. The focus will be on the neurocognitive basis of such deficits.
* Study design: Comparative Non-randomised Prospective International Multi-Centre Study
* Study population: 49 Children treated for a BT aged 5-13 years, 32 children diagnosed with CF aged 5-13 years and 32 healthy controls aged 5-13 years.

Social Cognition in Children Treated for a Brain Tumour

Social Cognition in Children Treated for a Brain Tumour: A Prospective Longitudinal Multi-Centre Study

Change in performance on tests of social cognition from time 1 (diagnosis) to time 2 (3 years later).

Parent and Teacher reports of social and emotional functioning from time 1 (diagnosis) to time 2 (3 years later).

The influence of individual biographical and medical characteristics (age at diagnosis, histology, sex, tumor site, treatment) on change in performance on tests of social cognition from time 1 to time 2.

Radboud University Medical Center

Universitaire Ziekenhuizen KU Leuven

Amsterdam UMC, location VUmc

University Medical Center Groningen

Clinical Neuropsychologist

Heart and Blood Diseases

Behaviors and Mental Disorders

Immune System Diseases

Stroke

Cognition Disorders

Sclerosis

Multiple Sclerosis

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Experimental group. Receives T-ScEmo Treatment during the study between T0 and T1

Waiting list group: Will be on waiting list for instead of the treatment for the duration of the treatment between T0 and T1.

T-ScEmo is a multifaceted treatment protocol that has the overall aim to improve social cognition, regulation of social behaviour and social participation in everyday life (Westerhof et al., 2017; 2019). The treatment includes, in addition to practicing social cognitive skills throughout the treatment, close involvement of a significant other, and homework assignments. The treatment consists of three modules that address 1) perception of social information including facial expressions of emotions, 2) perspective taking and understanding of social information and 3) regulation of social behaviour. The treatment contains 15-one hour live treatment sessions with a neuropsychologist and 5 online practice sessions, once or twice a week. In the online sessions, the patient can practice the information at home as a neuropsychologist is available for questions. When patients find it too difficult to practice individually at home, there is a opportunity to offer these sessions as live sessions

Treatment social cognition and emotion regulation (T-ScEmo)

A Heegers, MSc.

M.J.J. Gerritssen, dr.

Amber Heegers, MSc.

J.M. Spikman, Prof. Dr.

Impairments in aspects of social cognition are disorder-transcending: these have been demonstrated in various neurological disorders, such as traumatic brain injury (TBI), stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis (MS). Social cognition involves processing of social information, in particular the abilities to perceive social signals, understand others and respond appropriately (Adolphs 2001). Crucial aspects of social cognition are the recognition of facial expressions of emotions, perspective taking (also referred to as mentalizing or Theory of Mind), and empathy. Impairments in social cognition can have a large negative impact on self-care, communication, social and professional functioning, and thus on quality of life of patients.

Recently, a first multi-faceted treatment for social cognitive impairments in TBI was developed and evaluated; T-ScEmo (Training Social Cognition and Emotion). T-ScEmo turned out to be effective in reducing social cognitive symptoms and improving daily life social functioning in this particular group, with effects lasting over time (Westerhof-Evers et al, 2017, 2019).

Unfortunately, up till now there are no evidence based, transdiagnostic treatment possibilities available for these impeding social cognition impairments in neurological patient groups, other than TBI. Therefore the aim of the present study is to investigate whether T-ScEmo is effective for social cognition disorders in patients with different neurological impairments, such as stroke (including subarachnoidal haemorrhage (SAH)), brain tumours, MS, infection (meningitis, encephalitis) and other. The secondary objective is to determine which patient related factors are of influence on treatment effectiveness. In short, hopefully this study can contribute to a treatment possibility for social cognition disorders for all patients with various neurological disorders.

It is expected that T-ScEmo will be effective for various neurological disorders, based on previous research of Westerhof-Evers et al. (2017, 2019). Since social cognition disorders within patients with traumatic brain injury do all have the same ethiology it is expected that the treatment will show the same effects for patients with various neurological disorders. Therefore it is expected that patients will improve on social cognition, social participation and quality of life and social behaviour, that these results will last over time.

Experimental condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment

Waiting list condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 3 months after T0 T2, follow-up measurement within 3 - 5 months after T1

TBI group T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment

The participating patients are randomly allocated into two groups: an experimental condition and a waiting list condition.

In addition, a group of patients with Traumatic Brain Injury will receive T-ScEmo following regular care.

The neuropsychologist who leads T1 and T2 measurements will be masked for the fact of which patient will be draw in which clinical condition (experimental group or control group), however this cannot be guaranteed since patients may talk about their experience.

Improving Social Cognition and Social Behaviour in Various Brain Disorders

Improving Social Cognition and Social Behaviour in Various Brain Disorders.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Executive functioning will be measured with the Controlled Oral Word Association Test (COWAT).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Executive functioning will be measured with the Key Search Test of the Behavioural Assessment of the Dysexecutive Syndrome.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Verbal memory will be measured with Dutch version of the Rey Auditory Verbal Learning Test (15 Words Test).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Working memory will be measured with the Digit Span Test of the Wechsler Adult Intelligence Scale IV.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Language will be measured with the semantic fluency test.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Mental speed and attention will be measured with the Trail Making Test (TMT).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Mental speed will be measured with the Symbol Digit Modalities Test (SDMT).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Premorbid intelligence will be measured with Dutch version of the Adult Reading Test (NLV).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

The level of physical and mental fatigue will be measured with the Dutch Multifactor Fatigue Scale (DMFS).

This scale has a range between 38 and 190. A higher outcome means more complaints.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Health related physical and practical limitations will be measured with the RAND-36 Health Survey.

A higher outcome means better functioning.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Coping will be measured with the Utrecht Coping List (UCL)

A higher outcome means a better fitting coping style.

The main study parameter will be the difference between baseline (T0) and follow-up (T2) on Dysexecutive Questionnaire Social scales proxy version (DEX-Socproxy; Spikman et al., 2013; Westerhof-Evers, 2017). This scale is scored by the involved proxy of the patient (life partner, family member, friend) and measures the social aspects in daily life: 1) social convention, 2) behavioural-emotional selfregulation 3) metacognition. A higher outcome means more behavioural complaints.

Performance on neuropsychological test measuring emotion recognition; Eckman-60 faces test (EFT). This test has a range between 0 and 60. A higher outcome means a better performance.

Performance on neuropsychological test measuring Theory of Mind; Happé cartoons test. This test has a range between 0 and 36. A higher outcome means a better performance.

Performance on neuropsychological test measuring Theory of Mind: Faux Pas test. This test has a range between 0 and 10. A higher outcome means a better performance.

Performance on neuropsychological test measuring inhibition; Hailing Sentence Completion Test. This test has a range between 1 and 10. A higher outcome means a better performance.

Demographic information such as age, sex, educational level, will be obtained from medical records and anamnesis.

Self-reated social behaviour will be measured with a self rating on the Dysexecutive questionnaire Social Scales. Measuring the social aspects in daily life: 1) social convention, 2) behavioural-emotional selfregulation 3) metacognition. This scale has a range between 0 and 80. A higher outcome means more complaints.

Self-rated social behavior will be measured with the Interpersonal Reactivity Index (IRI). This scale has a range between 0 and 108. A higher outcome means less behavioural complaints.

Self-rated social behavior will be measured with The Dutch version of the BAFQ social scales (BAFQ-SOC). Moreover, patients answer if they have changed on that certain topic after brain damage. A higher outcome means less behavioural complaints and more change.

Proxy-rated social behavior will be measured with the Interpersonal Reactivity Index, proxy version (IRI). This scale has a range between 0 and 108. A higher outcome means less behavioural complaints.

Proxy-rated social behavior will be measured with the Socioemotional Dysfunction Scale (SDS). This scale has a range between 40 and 200. A higher outcome means more complaints.

Proxy-rated social behavior will be measured with the Dutch version of the BAFQ social scales, proxy version (BAFQ-SOC). Moreover, proxies answer if patients have changed on that certain topic after brain damage. A higher outcome means less behavioural complaints and more change.

The presence of alexithymia will be measured with a self-rating on the Toronto Alexithymia Scale (TAS-20). This scale has a range between 20 and 100. A higher outcome means more complaints.

Quality of life will be determined with a self-rating on the Life Satisfaction Questionnaire (LSQ-9). This scale has a range between 6 and 54. A higher outcome means a higher subjective quality of life.

The level of societal participation will be measured with the scores on the Utrecht Scale for Evaluation of Rehabilitation (USER-P). A higher outcome means higher participation rate.

The level of societal participation will be measured with the Impact on Participation and Autonomy (IPA). A higher outcome means lower participation rate.

The level of mood and anxiety will be obtained with the Hospital Anxiety and Depression Scale (HADS). This scale has a range between 0 and 42. A higher outcome means more complaints.

The extend to which proxies experience a burden in taking care of the patient wil be measured with the Zarit burden interview. This scale has a range between 0 and 48. A higher outcome means more burden.

The extent to which patients in the treatment condition improve on their set treatment goals will be measured with the Goal Attainment Scale (GAS). This scale has a range between 1 and 10. A higher outcome means better attainment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Determinants of Health and Cancer: Investigating the Conceptions of Children From 6 to 11 Years Old	NCT04065542	Child Determinants of... Qualitative Res... Cancer		6 Years - 11 Years	University Hospital, Clermont-Ferrand
Social Cognition in Children Treated for a Brain Tumour	NCT01599052	Social Behaviou... Brain Neoplasms Cystic Fibrosis		5 Years - 12 Years	University Medical Center Groningen
Improving Social Cognition and Social Behaviour in Various Brain Disorders	NCT06330298	Stroke Multiple Sclero... Brain Tumor	Treatment socia...	18 Years - 75 Years	University Medical Center Groningen

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