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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04300712
Other study ID # Parpsych-Ed_2018
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date December 31, 2021

Study information

Verified date March 2020
Source GCS pour la recherche et la formation en sante mentale
Contact Sandrine Bonneton, MD
Phone 0033157278458
Email bonnetonsandrine@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Local partnerships between schools (preschool and elementary) and mental health public services are implemented in seven sites in France. They aim to improve recognition of difficulties related to mental health problems and to provide interventions to 3 to 8 years-old pupils in need. Our hypothesis that these local partnerships and interventions enhance the role of school in supporting good mental health and wellbeing of all children and the trajectories of children with mental health service needs. Theses also facilitate community support. One of them, early-interventions involve caregivers. Our objective is to enhance knowledge of the unmet mental healthcare need at school and to explore for whom, in which local context and how partnerships and early intervention work.


Description:

Teachers are legitimately concerned about children that encounter mental health problems. Mental healthcare might be indicated. Because of internal and external barriers of treatment, they could remain inaccessible for many children in need. School staff should not try to diagnose conditions. However, collaborative interventions delivered by school and mental healthcare staffs in association with other stakeholders as parents and associations should ensure clear systems and processes in place for identifying possible mental health problems and support children and their parents. Local partnership and early interventions will be elaborated within focus groups bringing together all stakeholders and will be experimented in 7 French sites (preschool, primary school and local public health service) thereafter. These complex interventions will be evaluated through mixed-methods including qualitative case studies and a pragmatic trial. This feasibility study will produce a set of findings that will permit to argue conceptual framework of partnership and early intervention, to provide guidelines to implement these in France considering children needs, local context, all stakeholders acceptance and public health efficacy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2000
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 8 Years
Eligibility Inclusion Criteria:

- Attending pre- and elementary schools involved in the ParpsychEd partnerships.

Exclusion Criteria:

- Absence of parents and/or child consent.

Study Design


Related Conditions & MeSH terms

  • School Difficulties Associated With Mental Health Problems

Intervention

Behavioral:
Questionnaires at the start and end of the school year
Interventions will be proposed to children identified in a worrisome situation. The Strengths and Difficulties. Questionnaire will be used by teachers to score these situations. The recognition process of mental health problem and need continue with responses. Responses are supporting a graduated response process in school and facilitating external support when needed (mental health services, community supports). Early intervention is one of all responses, which involve caregivers. Responses to worrisome situations aim to improve schooling conditions, to acknowledge mental health problems or condition and the health services need for children. To evaluate the intervention, the impact supplement of SDQ and the follow-up questions will be used by the teachers and the parents of children who benefit of the intervention. The interventions will be experimented during year 2020-21. Children might benefit of them from several weeks to one year, according to their need.

Locations

Country Name City State
France EPSM Barthélémy Durand Grigny Essone
France EPSM Val de Lys La Couture Pas De Calais
France Centre Hospitalier Sainte Anne Paris
France Fondation Bon Sauveur de la Manche Picauville
France EPSM de Guadeloupe Saint-Claude Guadeloupe
France Centre Hospitalier de Saint Denis Saint-Denis
France EPSM Val de Lys Vieille chapelle Pas De Calais

Sponsors (1)

Lead Sponsor Collaborator
GCS pour la recherche et la formation en sante mentale

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of 3 to 8 years old children identified with mental health services need Evolution of the number of 3 to 8 years old children identified with mental health services 24 months
Secondary Strengths and Difficulties Questionnaire (SDQ) Changes in the impact supplement and the follow-up questions - parents and teachers 12 months
Secondary Healthcare access, barriers to treatment, intervention acceptance Healthcare access, barriers to treatment, intervention acceptance 12 months
Secondary Parent refusal rate to let their child benefit of all responses Parent refusal rate to let their child benefit of all responses 12 months
Secondary Parent refusal rate to let their child benefit of the early intervention Parent refusal rate to let their child benefit of the early intervention 12 months
Secondary Parents refusal rate to plan appointment in public health services as indicated after the intervention Parents refusal rate to plan appointment in public health services as indicated after the intervention 18 months
Secondary Mental health and mental health services representation and use Changes in the mental health representations of parents, teachers and others professionnals 18 months