NCT04300712

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2019

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

May 10, 2019

Last Update Submit

March 6, 2020

Conditions

Keywords

mental healthchildren psychiatryschool difficultiespsychosocial interventions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Strengths and Difficulties Questionnaire (SDQ)

    12 months

  • Healthcare access, barriers to treatment, intervention acceptance

    12 months

  • Parent refusal rate to let their child benefit of all responses

    12 months

  • Parent refusal rate to let their child benefit of the early intervention

    12 months

  • Parents refusal rate to plan appointment in public health services as indicated after the intervention

    18 months

  • +1 more secondary outcomes

Study Arms (1)

Tracking of the children with difficulties

OTHER

All parents and teachers will respond to the questionnaires and the beginning and end of school year which is not done in the routine for tracking the children in difficulty.

Behavioral: Questionnaires at the start and end of the school year

Interventions

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.

Also known as: Questionnaires at the start and end of the school year completed by teachers and directors, Questionnaire before and after intervention completed by teachers and parents., Questionnaires during and after the intervention, completed by public mental health professionals
Tracking of the children with difficulties

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Absence of parents and/or child consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

EPSM Barthélémy Durand

Grigny, Essone, France

Location

EPSM de Guadeloupe

Saint-Claude, Guadeloupe, France

Location

EPSM Val de Lys

La Couture, Pas De Calais, France

Location

EPSM Val de Lys

Vieille Chapelle, Pas De Calais, France

Location

Centre Hospitalier Sainte Anne

Paris, France

Location

Fondation Bon Sauveur de la Manche

Picauville, France

Location

Centre Hospitalier de Saint Denis

Saint-Denis, France

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Jean-Luc Roelandt, MD

    French World Health Organization Collaborating Centre for Research and Training in Mental Health

    STUDY DIRECTOR
  • Sandrine Bonneton, MD

    French World Health Organization Collaborating Centre for Research and Training in Mental Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandrine Bonneton, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

March 9, 2020

Study Start

September 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations