Child Behavior Disorders
Conditions
Brief summary
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
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.
Interventions
DEVICEInner Garden
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.)
Sponsors
Ullo World
Groupe Hospitalier de la Rochelle Ré Aunis
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Crises | 8 months after inclusion | Agitation crises of moderate to severe intensity, which did not allow the child to reintegrate the group of care during the sessions A mild state of agitation does not require the child to be removed from the group and from the common place of care; A moderate agitation requires removal of the child from the group but not from the common place of care; In case of serious agitation, the child must be removed from the group and from the common care area to a calming room where the caregiver will take care of him/her individually. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score at the Emotion Regulation Checklist | 4 months after inclusion | The ERC items assess affective stability, intensity, valence, flexibility, and situational appropriateness of children between the ages of 6 to 12 years. Items are rated by a parent on a 4-point scale (1=never, 2=sometimes, 3=often, 4=almost always) and are weighted both negatively and positively. The ERC is comprised of two scales: emotion regulation (10 items) and emotional lability/negativity (14 items). The former scale assesses expression of emotions, empathy, and emotional self-awareness, with higher scores indicating greater adaptive regulatory processes (range 10-40). The latter scale assesses lack of flexibility, anger dysregulation, and mood lability, with higher scores indicating greater emotion dysregulation (range 14-56). The Composite emotional regulation score is the sum of the emotion regulation score and the inverted emotional lability score with higher scores indicating greater adaptive regulatory processes (range 24-96). |
| Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported | 9 months after inclusion | Assault or violence against health professional with a statement in the dedicated application. In cases of severe agitation, the child's hetero-aggressive actions may injure the caregiver. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Wards without the Inner Garden biofeedback tool | 30 |
| Inner Garden Wards with the Inner Garden biofeedback tool
Inner Garden: 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.) | 33 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Improvement in their condition no longer justifies care in the Children's Hospital Unit | 1 | 4 |
Baseline characteristics
| Characteristic | Inner Garden | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 33 Participants | 30 Participants | 63 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 7.2 years STANDARD_DEVIATION 1.7 | 6.9 years STANDARD_DEVIATION 1.8 | 7.1 years STANDARD_DEVIATION 1.7 |
| Enrolled in school No | 2 Participants | 1 Participants | 3 Participants |
| Enrolled in school Yes | 31 Participants | 29 Participants | 60 Participants |
| Home Family home | 25 Participants | 27 Participants | 52 Participants |
| Home Foster care | 6 Participants | 3 Participants | 9 Participants |
| Home Institution | 2 Participants | 0 Participants | 2 Participants |
| Number of years of inpatient care for children | 2.4 years STANDARD_DEVIATION 1.3 | 2.8 years STANDARD_DEVIATION 1.4 | 2.6 years STANDARD_DEVIATION 1.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Reason for hospitalisation Conduct and/or emotional disorders | 9 Participants | 3 Participants | 12 Participants |
| Reason for hospitalisation Developmental disorders | 14 Participants | 15 Participants | 29 Participants |
| Reason for hospitalisation Observation for suspected psychiatric illness, unspecified | 4 Participants | 6 Participants | 10 Participants |
| Reason for hospitalisation Other (mental retardation, hyperkinetic, social, adjustment disorders, congenital malformations) | 6 Participants | 6 Participants | 12 Participants |
| Region of Enrollment France | 33 participants | 30 participants | 63 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 27 Participants | 25 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 33 |
| other Total, other adverse events | 0 / 30 | 0 / 33 |
| serious Total, serious adverse events | 0 / 30 | 0 / 33 |
Outcome results
Primary
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 A mild state of agitation does not require the child to be removed from the group and from the common place of care; A moderate agitation requires removal of the child from the group but not from the common place of care; In case of serious agitation, the child must be removed from the group and from the common care area to a calming room where the caregiver will take care of him/her individually.
Time frame: 8 months after inclusion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Crises | 97 crises |
| Inner Garden | Number of Crises | 35 crises |
Secondary
Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported
Assault or violence against health professional with a statement in the dedicated application. In cases of severe agitation, the child's hetero-aggressive actions may injure the caregiver.
Time frame: 9 months after inclusion
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported | Assault or violence against health professional | 2 Participants |
| Control | Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported | No assault or violence against health professional | 28 Participants |
| Inner Garden | Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported | Assault or violence against health professional | 1 Participants |
| Inner Garden | Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported | No assault or violence against health professional | 32 Participants |
Secondary
Score at the Emotion Regulation Checklist
The ERC items assess affective stability, intensity, valence, flexibility, and situational appropriateness of children between the ages of 6 to 12 years. Items are rated by a parent on a 4-point scale (1=never, 2=sometimes, 3=often, 4=almost always) and are weighted both negatively and positively. The ERC is comprised of two scales: emotion regulation (10 items) and emotional lability/negativity (14 items). The former scale assesses expression of emotions, empathy, and emotional self-awareness, with higher scores indicating greater adaptive regulatory processes (range 10-40). The latter scale assesses lack of flexibility, anger dysregulation, and mood lability, with higher scores indicating greater emotion dysregulation (range 14-56). The Composite emotional regulation score is the sum of the emotion regulation score and the inverted emotional lability score with higher scores indicating greater adaptive regulatory processes (range 24-96).
Time frame: 4 months after inclusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Score at the Emotion Regulation Checklist | Emotional regulation score | 21.8 score on a scale | Standard Deviation 6.7 |
| Control | Score at the Emotion Regulation Checklist | Emotional Lability/Negativity score | 33.1 score on a scale | Standard Deviation 10.5 |
| Control | Score at the Emotion Regulation Checklist | Composite emotional regulation score | 54.9 score on a scale | Standard Deviation 11.6 |
| Inner Garden | Score at the Emotion Regulation Checklist | Emotional regulation score | 21.7 score on a scale | Standard Deviation 3.8 |
| Inner Garden | Score at the Emotion Regulation Checklist | Emotional Lability/Negativity score | 34.9 score on a scale | Standard Deviation 8.5 |
| Inner Garden | Score at the Emotion Regulation Checklist | Composite emotional regulation score | 56.6 score on a scale | Standard Deviation 9 |
Secondary
Score at the Emotion Regulation Checklist
The ERC items assess affective stability, intensity, valence, flexibility, and situational appropriateness of children between the ages of 6 to 12 years. Items are rated by a parent on a 4-point scale (1=never, 2=sometimes, 3=often, 4=almost always) and are weighted both negatively and positively. The ERC is comprised of two scales: emotion regulation (10 items) and emotional lability/negativity (14 items). The former scale assesses expression of emotions, empathy, and emotional self-awareness, with higher scores indicating greater adaptive regulatory processes (range 10-40). The latter scale assesses lack of flexibility, anger dysregulation, and mood lability, with higher scores indicating greater emotion dysregulation (range 14-56). The Composite emotional regulation score is the sum of the emotion regulation score and the inverted emotional lability score with higher scores indicating greater adaptive regulatory processes (range 24-96).
Time frame: 8 months after inclusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Score at the Emotion Regulation Checklist | Emotional regulation score | 21.6 score on a scale | Standard Deviation 4.2 |
| Control | Score at the Emotion Regulation Checklist | Emotional Lability/Negativity score | 32.0 score on a scale | Standard Deviation 7.5 |
| Control | Score at the Emotion Regulation Checklist | Composite emotional regulation score | 53.6 score on a scale | Standard Deviation 7.4 |
| Inner Garden | Score at the Emotion Regulation Checklist | Emotional regulation score | 22.5 score on a scale | Standard Deviation 3.7 |
| Inner Garden | Score at the Emotion Regulation Checklist | Emotional Lability/Negativity score | 34.5 score on a scale | Standard Deviation 7.6 |
| Inner Garden | Score at the Emotion Regulation Checklist | Composite emotional regulation score | 56.7 score on a scale | Standard Deviation 7.3 |