An interventional study of Inner Garden in Child Behavior Disorders, sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Completed at 1 site in France. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Groupe Hospitalier de la Rochelle Ré Aunis · Not applicable, Interventional, and Other
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.
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.
35 studies on the registry are indexed under Child Behavior Disorders; 10 are open to participants now.
This study's enrollment of 63 is below the median of 134 across 25 interventional studies indexed under Child Behavior Disorders.
Browse Child Behavior Disorders studies →Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Wards without the "Inner Garden" biofeedback tool
Wards with the "Inner Garden" biofeedback tool
Device: 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.)
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
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
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
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
| Milestone | Control | Inner Garden |
|---|---|---|
| Started | 30 | 33 |
| Completed | 29 | 29 |
| Not completed | 1 | 4 |
| Withdrew: Improvement in their condition no longer justifies care in the children's hospital unit | 1 | 4 |
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.
| crises | Control | Inner Garden |
|---|---|---|
| Number of Crises | 97 | 35 |
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).
| score on a scale | Control | Inner Garden |
|---|---|---|
| Emotional regulation score | 21.8 ± 6.7 | 21.7 ± 3.8 |
| Emotional Lability/Negativity score | 33.1 ± 10.5 | 34.9 ± 8.5 |
| Composite emotional regulation score | 54.9 ± 11.6 | 56.6 ± 9.0 |
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).
| score on a scale | Control | Inner Garden |
|---|---|---|
| Emotional regulation score | 21.6 ± 4.2 | 22.5 ± 3.7 |
| Emotional Lability/Negativity score | 32.0 ± 7.5 | 34.5 ± 7.6 |
| Composite emotional regulation score | 53.6 ± 7.4 | 56.7 ± 7.3 |
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.
| Participants | Control | Inner Garden |
|---|---|---|
| Assault or violence against health professional | 2 | 1 |
| No assault or violence against health professional | 28 | 32 |
Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Inner Garden | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Categorical(Participants) | Control | Inner Garden | Total |
|---|---|---|---|
| <=18 years | 30 | 33 | 63 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Control | Inner Garden | Total |
|---|---|---|---|
| Mean | 6.9 ± 1.8 | 7.2 ± 1.7 | 7.1 ± 1.7 |
| Sex: Female, Male(Participants) | Control | Inner Garden | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 25 | 27 | 52 |
| Race and Ethnicity Not Collected(Participants) | Control | Inner Garden | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Control | Inner Garden | Total |
|---|---|---|---|
| France | 30 | 33 | 63 |
| Home(Participants) | Control | Inner Garden | Total |
|---|---|---|---|
| Institution | 0 | 2 | 2 |
| Foster care | 3 | 6 | 9 |
| Family home | 27 | 25 | 52 |
| Enrolled in school(Participants) | Control | Inner Garden | Total |
|---|---|---|---|
| Yes | 29 | 31 | 60 |
| No | 1 | 2 | 3 |
| Reason for hospitalisation(Participants) | Control | Inner Garden | Total |
|---|---|---|---|
| Developmental disorders | 15 | 14 | 29 |
| Conduct and/or emotional disorders | 3 | 9 | 12 |
| Other (mental retardation, hyperkinetic, social, adjustment disorders, congenital malformations) | 6 | 6 | 12 |
| Observation for suspected psychiatric illness, unspecified | 6 | 4 | 10 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be made available with publication. Keyword are Child Behavior, Psychomotor Agitation, Psychiatric Nursing, Child Day Care Center, Tool Use Behavior, Emotional Regulation. The available version will be the locked database. The database will be made available by the study director upon request up to 15 years after publication. Medical Subject Headings (MESH) terms will be used to describe clinical data. Methodology for will be provided in the publication. International standard unit will be used.
Time frame: Data will be made available with publication (expected at the end of 2021 or beginning of 2022) and up to 15 years after the end of the study.
Access criteria: The database will be made available by the study director upon request
Ran from Nov 2020 to primary completion in Jul 2021, 8 months.
Results were first posted in Aug 2024, 3 years 1 month after primary completion.
Of 16 interventional studies with no phase under Child Behavior Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 86. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier de la Rochelle Ré Aunis