Trial Outcomes & Findings for The Inner Garden and Care for Children With Moderate to Severe Agitation (NCT NCT04610281)

Last Updated: 2024-08-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

63 participants

Primary outcome timeframe

8 months after inclusion

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Control Wards without the "Inner Garden" biofeedback tool	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.)
Overall Study STARTED	30	33
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Wards without the "Inner Garden" biofeedback tool	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.)
Overall Study Improvement in their condition no longer justifies care in the Children's Hospital Unit	1	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=30 Participants Wards without the "Inner Garden" biofeedback tool	Inner Garden n=33 Participants 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.)	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=30 Participants	33 Participants n=33 Participants	63 Participants n=63 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=30 Participants	0 Participants n=33 Participants	0 Participants n=63 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	0 Participants n=33 Participants	0 Participants n=63 Participants
Age, Continuous	6.9 years STANDARD_DEVIATION 1.8 • n=30 Participants	7.2 years STANDARD_DEVIATION 1.7 • n=33 Participants	7.1 years STANDARD_DEVIATION 1.7 • n=63 Participants
Sex: Female, Male Female	5 Participants n=30 Participants	6 Participants n=33 Participants	11 Participants n=63 Participants
Sex: Female, Male Male	25 Participants n=30 Participants	27 Participants n=33 Participants	52 Participants n=63 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	30 participants n=30 Participants	33 participants n=33 Participants	63 participants n=63 Participants
Home Institution	0 Participants n=30 Participants	2 Participants n=33 Participants	2 Participants n=63 Participants
Home Foster care	3 Participants n=30 Participants	6 Participants n=33 Participants	9 Participants n=63 Participants
Home Family home	27 Participants n=30 Participants	25 Participants n=33 Participants	52 Participants n=63 Participants
Enrolled in school Yes	29 Participants n=30 Participants	31 Participants n=33 Participants	60 Participants n=63 Participants
Enrolled in school No	1 Participants n=30 Participants	2 Participants n=33 Participants	3 Participants n=63 Participants
Reason for hospitalisation Developmental disorders	15 Participants n=30 Participants	14 Participants n=33 Participants	29 Participants n=63 Participants
Reason for hospitalisation Conduct and/or emotional disorders	3 Participants n=30 Participants	9 Participants n=33 Participants	12 Participants n=63 Participants
Reason for hospitalisation Other (mental retardation, hyperkinetic, social, adjustment disorders, congenital malformations)	6 Participants n=30 Participants	6 Participants n=33 Participants	12 Participants n=63 Participants
Reason for hospitalisation Observation for suspected psychiatric illness, unspecified	6 Participants n=30 Participants	4 Participants n=33 Participants	10 Participants n=63 Participants
Number of years of inpatient care for children	2.8 years STANDARD_DEVIATION 1.4 • n=30 Participants	2.4 years STANDARD_DEVIATION 1.3 • n=33 Participants	2.6 years STANDARD_DEVIATION 1.3 • n=63 Participants

PRIMARY outcome

Timeframe: 8 months after inclusion

Outcome measures

Outcome measures
Measure	Control n=30 Participants Wards without the "Inner Garden" biofeedback tool	Inner Garden n=33 Participants 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.)
Number of Crises	97 crises	35 crises

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Control n=30 Participants Wards without the "Inner Garden" biofeedback tool	Inner Garden n=33 Participants 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.)
Score at the Emotion Regulation Checklist Emotional regulation score	21.8 score on a scale Standard Deviation 6.7	21.7 score on a scale Standard Deviation 3.8
Score at the Emotion Regulation Checklist Emotional Lability/Negativity score	33.1 score on a scale Standard Deviation 10.5	34.9 score on a scale Standard Deviation 8.5
Score at the Emotion Regulation Checklist Composite emotional regulation score	54.9 score on a scale Standard Deviation 11.6	56.6 score on a scale Standard Deviation 9.0

SECONDARY outcome

Timeframe: 8 months after inclusion

Outcome measures

Outcome measures
Measure	Control n=29 Participants Wards without the "Inner Garden" biofeedback tool	Inner Garden n=29 Participants 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.)
Score at the Emotion Regulation Checklist Composite emotional regulation score	53.6 score on a scale Standard Deviation 7.4	56.7 score on a scale Standard Deviation 7.3
Score at the Emotion Regulation Checklist Emotional regulation score	21.6 score on a scale Standard Deviation 4.2	22.5 score on a scale Standard Deviation 3.7
Score at the Emotion Regulation Checklist Emotional Lability/Negativity score	32.0 score on a scale Standard Deviation 7.5	34.5 score on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=30 Participants Wards without the "Inner Garden" biofeedback tool	Inner Garden n=33 Participants 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.)
Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported Assault or violence against health professional	2 Participants	1 Participants
Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported No assault or violence against health professional	28 Participants	32 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inner Garden

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brigitte Laurent

Ullo World

Phone: +33782096875

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place