The Inner Garden and Care for Children With Moderate to Severe Agitation

Study Overview
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Brief Summary
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The objective is to compare the care including the solution of ambient sensory biofeedback Inner Garden, compared to the care without this solution, on the regulation of behavioral disorders during a crisis requiring to take the child out of group care. The nursing support with the Inner Garden tool in three care units will be compared with the practice in six other units not equipped with this tool.

Detailed Description
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Psychiatric illnesses affect more than one person in five each year. In France, the majority of disorders among minors under the care of child psychiatry in full or part-time hospitalization are disorders of psychological development (32%) and behavioural and emotional disorders (24.6%). Hospitalisation is reserved for the most complex acute crisis situations, as well as for children who need to be cared for by a multidisciplinary team several times a week to support their psychological development. In our study, the investigators focus on one of the clinical manifestations regularly present: the state of agitation when its intensity is moderate to severe. The state of agitation is defined as a psychic, motor and relational behavioural disorder that leads to a reaction of intolerance on the part of people in the entourage. The care teams will then implement care actions that will be a graduated response adapted to the intensity of these states of agitation. In addition to the support provided by a caregiver, the investigators propose to use the Inner Garden system developed in 2014 at the laboratory of National Institute for Research in Digital Science and Technology in Bordeaux. It is an interactive Zen garden allowing to present feedback (topographical, physiological) under different sensory modalities.

Official Title
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Pilot Study on the Care for Children With Moderate to Severe Agitation, With or Without the Use of a Semi-supervised Support Solution

Conditions
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Child Behavior Disorders

Intervention / Treatment
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* Device: Inner Garden


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Taken care in Children's Hospitalization Unit of Child Psychiatry Department, Parent affiliated or beneficiary of social security, Information to the child and the legal representative(s) and signed consent by the legal representative(s). Exclusion Criteria: Refusal to participate on the part of the child and/or legal representative(s).

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Wards without the Inner Garden biofeedback tool | |
| Experimental: Inner Garden<br>Wards with the Inner Garden biofeedback tool | Device: Inner Garden<br>* Care actions adapted to the intensity of the states of agitation (The child can be removed from the group while remaining in the same room on a chair with a caregiver. If the problems are too serious, the child can be accompanied to a soothing room where the carer will take care of him/her individually. In units equipped with Inner Garden, the child can use it under semi- supervision of nurses.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of crises | Agitation crises of moderate to severe intensity, which did not allow the child to reintegrate the group of care during the sessions | 8 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score at the Emotion Regulation Checklist | This questionnaire measures the perception of adults close to children about their ability to regulate their emotions in everyday life. It proposes 24 behavioural statements that refer to emotional responses and reactions of joy, anger, empathy with peers and adults, frustration, and activity transitions. For each statement, the adult rates the frequency of the behaviour on a 4-point Likert scale: never, sometimes, often, almost always. | 4 months after inclusion | 
| Score at the Emotion Regulation Checklist | This questionnaire measures the perception of adults close to children about their ability to regulate their emotions in everyday life. It proposes 24 behavioural statements that refer to emotional responses and reactions of joy, anger, empathy with peers and adults, frustration, and activity transitions. For each statement, the adult rates the frequency of the behaviour on a 4-point Likert scale: never, sometimes, often, almost always. | 8 months after inclusion | 
| Number of adverse events related to aggression/violence during group care sessions | Assault or violence against health professional with a statement in the dedicated application | 9 months after inclusion |