School Difficulties Associated With Mental Health ProblemsParpsych-EdNCT04300712
Partnerships Between Schools and Public Mental Health Departments: Investigation of Multi-professional Interventions for Children Aged 3 to 8 With Mental Health Issues (Parpsych-Ed)
A study testing Questionnaires at the start and end of the school year in people with School Difficulties Associated With Mental Health Problems, run by GCS pour la recherche et la formation en sante mentale at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- School Difficulties Associated With Mental Health Problems
- What is being tested?
- Questionnaires at the start and end of the school year
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Sep 2020to 31 Dec 2021
- 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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attending pre- and elementary schools involved in the ParpsychEd partnerships.
Who cannot join
- Absence of parents and/or child consent.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
EPSM Barthélémy Durand
Grigny, Essone
EPSM Val de Lys
La Couture, Pas De Calais
Laurent Lauwerier, MD, llauwerier@epsm-stvenant.fr
Centre Hospitalier Sainte Anne
Paris
Marie-Odile Perouse de MontClos, MD, perousedemontclos@ch-sainte-anne.fr
Yann Cross, MD
Fondation Bon Sauveur de la Manche
Picauville
Justine Levaillant, justine.levaillant@fbs50.fr
EPSM de Guadeloupe
Saint-Claude, Guadeloupe
Caroll Devaux, MD, caroll.devaux@epsm-guadeloupe.fr
Centre Hospitalier de Saint Denis
Saint-Denis
Jean-Pierre Benoit, jeanpierre.benoit@ch-stdenis.fr
EPSM Val de Lys
Vieille Chapelle, Pas De Calais
Laurent Lauwerier, MD, llauwerier@epsm-stvenant.fr
About this study
Official title: Partnerships Between Schools and Public Mental Health Departments: Investigation of Multi-professional Interventions for Children Aged 3 to 8 With Mental Health Issues (Parpsych-Ed).
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.
Read the detailed 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.
- Being tested
- Questionnaires at the start and end of the school year
- Keywords
- mental health, children psychiatry, school difficulties, psychosocial interventions
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires at the start and end of the school yearBehavioural
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaires at the start and end of the school year |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (6)
Strengths and Difficulties Questionnaire (SDQ)
Changes in the impact supplement and the follow-up questions - parents and teachers
Measured: 12 months
Healthcare access, barriers to treatment, intervention acceptance
Healthcare access, barriers to treatment, intervention acceptance
Measured: 12 months
Parent refusal rate to let their child benefit of all responses
Parent refusal rate to let their child benefit of all responses
Measured: 12 months
Parent refusal rate to let their child benefit of the early intervention
Parent refusal rate to let their child benefit of the early intervention
Measured: 12 months
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
Measured: 18 months
Mental health and mental health services representation and use
Changes in the mental health representations of parents, teachers and others professionnals
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School Difficulties Associated With Mental Health ProblemsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS pour la recherche et la formation en sante mentale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Roelandt, MD, Study director, French World Health Organization Collaborating Centre for Research and Training in Mental HealthSandrine Bonneton, MD, Principal investigator, French World Health Organization Collaborating Centre for Research and Training in Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300712
- Sponsor's protocol ID
- Parpsych-Ed_2018
- Acronym
- Parpsych-Ed
- Status last verified
- Mar 2020
- First submitted
- 10 May 2019
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnerships Between Schools and Public Mental Health Departments: Investigation of Multi-professional Interventions for Children Aged 3 to 8 With Mental Health Issues (Parpsych-Ed).
- ClinicalTrials.gov ID
- NCT04300712
- Acronym / sponsor ID
- Parpsych-Ed / Parpsych-Ed_2018
- Keywords
- mental health, children psychiatry, school difficulties, psychosocial interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- GCS pour la recherche et la formation en sante mentaleUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Mar 2020 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracking of the children with difficulties | Other | Behavioral: Questionnaires at the start and end of the school yearAll 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Attending pre- and elementary schools involved in the ParpsychEd partnerships.
Key exclusion criteria (1 listed)
- Absence of parents and/or child consent.
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 |
|---|---|---|
| Questionnaires at the start and end of the school yearAlso: 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 professionalsInterventions 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. | Behavioural | Tracking of the children with difficulties |
Primary outcome
number of 3 to 8 years old children identified with mental health services need
Time frame: 24 months
Evolution of the number of 3 to 8 years old children identified with mental health services
6 secondary outcomes
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 12 months
Healthcare access, barriers to treatment, intervention acceptance
Time frame: 12 months
Parent refusal rate to let their child benefit of all responses
Time frame: 12 months
Parent refusal rate to let their child benefit of the early intervention
Time frame: 12 months
Parents refusal rate to plan appointment in public health services as indicated after the intervention
Time frame: 18 months
Mental health and mental health services representation and use
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for School Difficulties Associated With Mental Health Problems
Recruiting
Youth-for-Youth Mental Wellness Care and Action
Mental Well-being, Adolescent Health
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.
Jean-Luc Roelandt, MD study director
French World Health Organization Collaborating Centre for Research and Training in Mental Health
Sandrine Bonneton, MD principal investigator
French World Health Organization Collaborating Centre for Research and Training in Mental Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires at the start and end of the school year in people with School Difficulties Associated With Mental Health Problems, run by GCS pour la recherche et la formation en sante mentale at 7 sites in France.
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 1 inclusion and 1 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 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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 Sandrine Bonneton, MD (0033157278458, bonnetonsandrine@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of 3 to 8 years old children identified with mental health services need (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2020.