Child Behavior DisordersESSAIMSNCT04610281

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

A study testing Inner Garden in people with Child Behavior Disorders, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 12 years
Conditions the study is for: Child Behavior Disorders
What is being tested?: Inner Garden
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteFrance
Study dates: 2 Nov 2020to 6 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

Refusal to participate on the part of the child and/or legal representative(s).

Trial locations and contacts

1 site in 1 country.

France1 site

Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle

Other trials in France

About this study

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

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.

Read the 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.

Conditions: Child Behavior Disorders
Being tested: Inner Garden
Medical subject headings: Child Behavior Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inner GardenDevice
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.)

Study groups in NCT04610281
Study group	Role	What they receive
Control	No intervention	Wards without the "Inner Garden" biofeedback tool
Inner Garden	Experimental	Wards with the "Inner Garden" biofeedback tool Receives: Device: Inner Garden

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 months after inclusion

Secondary outcomes (3)

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).
Measured: 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).
Measured: 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.
Measured: 9 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 20206 Jul 2021

First posted30 Oct 2020
Study start2 Nov 2020
Primary completion6 Jul 2021
Study completion6 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Child Behavior DisordersStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04610281
Sponsor's protocol ID: 2019/P08/360
Acronym: ESSAIMS
Status last verified: Feb 2024
First submitted: 26 Oct 2020
Last updated: 9 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Domon-Archambault V, Terradas MM, Drieu D, De Fleurian A, Achim J, Poulain S, Jerrar-Oulidi J. Mentalization-Based Training Program for Child Care Workers in Residential Settings. J Child Adolesc Trauma. 2019 Jun 21;13(2):239-248. doi: 10.1007/s40653-019-00269-x. eCollection 2020 Jun.
PubMed 32549935
Niquille M, Gremion C, Welker S, Damsa C. [Agitation in prehospital setting: view of emergency physicians]. Rev Med Suisse. 2007 Aug 15;3(121):1839-46. French.
PubMed 17892148
Tereno S, Soares I, Martins C, Celani M, Sampaio D. Attachment styles, memories of parental rearing and therapeutic bond: a study with eating disordered patients, their parents and therapists. Eur Eat Disord Rev. 2008 Jan;16(1):49-58. doi: 10.1002/erv.801.
PubMed 17879224
Lewis GF, Hourani L, Tueller S, Kizakevich P, Bryant S, Weimer B, Strange L. Relaxation training assisted by heart rate variability biofeedback: Implication for a military predeployment stress inoculation protocol. Psychophysiology. 2015 Sep;52(9):1167-74. doi: 10.1111/psyp.12455. Epub 2015 Jun 11.
PubMed 26095854
Zeman J, Shipman K, Suveg C. Anger and sadness regulation: predictions to internalizing and externalizing symptoms in children. J Clin Child Adolesc Psychol. 2002 Sep;31(3):393-8. doi: 10.1207/S15374424JCCP3103_11.
PubMed 12149977
Chicchi Giglioli IA, Pallavicini F, Pedroli E, Serino S, Riva G. Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders. Comput Math Methods Med. 2015;2015:862942. doi: 10.1155/2015/862942. Epub 2015 Aug 3.
PubMed 26339283
Baus O, Bouchard S. Moving from virtual reality exposure-based therapy to augmented reality exposure-based therapy: a review. Front Hum Neurosci. 2014 Mar 4;8:112. doi: 10.3389/fnhum.2014.00112. eCollection 2014.
PubMed 24624073
Gold G, Fazio L, Stolz JH, Herrman FR, Gattelet P, Zekry D. [Assessment of behavior in non-psychiatric settings: use of a simple and reliable method]. Rev Med Suisse. 2012 Nov 7;8(361):2119-21. French.
PubMed 23173347
Kay SR, Wolkenfeld F, Murrill LM. Profiles of aggression among psychiatric patients. I. Nature and prevalence. J Nerv Ment Dis. 1988 Sep;176(9):539-46. doi: 10.1097/00005053-198809000-00007.
PubMed 3418327

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Child Behavior Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study on the Care for Children With Moderate to Severe Agitation, With or Without the Use of a Semi-supervised Support Solution
ClinicalTrials.gov ID: NCT04610281
Acronym / sponsor ID: ESSAIMS / 2019/P08/360
Conditions: Child Behavior Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
Collaborators: Ullo World
Study start: 2 Nov 2020 (actual)
Primary completion: 6 Jul 2021 (actual)
Study completion: 6 Jul 2021 (actual)
First posted: 30 Oct 2020 (actual)
Results: Posted 9 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Wards without the "Inner Garden" biofeedback tool
Inner Garden	Experimental	Device: Inner GardenWards with the "Inner Garden" biofeedback tool

Who may qualify

Ages: 3 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (1 listed)

Refusal to participate on the part of the child and/or legal representative(s).

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
Inner GardenCare 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.)	Device	Inner Garden

Primary outcome

Number of Crises
Time frame: 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.

3 secondary outcomes

Score at the Emotion Regulation Checklist
Time frame: 4 months after inclusion
Score at the Emotion Regulation Checklist
Time frame: 8 months after inclusion
Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported
Time frame: 9 months after inclusion

Results and safety

Results posted to the registry on 9 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	30	29
Inner Garden	33	29

Primary outcome: Number of Crises

Time frame: 8 months after inclusion. Number. Unit: crises

Measure	Control n = 30	Inner Garden n = 33
Value	97	35

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Inner Garden	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32549935Domon-Archambault V, Terradas MM, Drieu D, De Fleurian A, Achim J, Poulain S, Jerrar-Oulidi J. Mentalization-Based Training Program for Child Care Workers in Residential Settings. J Child Adolesc Trauma. 2019 Jun 21;13(2):239-248. doi: 10.1007/s40653-019-00269-x. eCollection 2020 Jun.
Background: PubMed 17892148Niquille M, Gremion C, Welker S, Damsa C. [Agitation in prehospital setting: view of emergency physicians]. Rev Med Suisse. 2007 Aug 15;3(121):1839-46. French.
Background: PubMed 17879224Tereno S, Soares I, Martins C, Celani M, Sampaio D. Attachment styles, memories of parental rearing and therapeutic bond: a study with eating disordered patients, their parents and therapists. Eur Eat Disord Rev. 2008 Jan;16(1):49-58. doi: 10.1002/erv.801.
Background: PubMed 26095854Lewis GF, Hourani L, Tueller S, Kizakevich P, Bryant S, Weimer B, Strange L. Relaxation training assisted by heart rate variability biofeedback: Implication for a military predeployment stress inoculation protocol. Psychophysiology. 2015 Sep;52(9):1167-74. doi: 10.1111/psyp.12455. Epub 2015 Jun 11.
Background: PubMed 12149977Zeman J, Shipman K, Suveg C. Anger and sadness regulation: predictions to internalizing and externalizing symptoms in children. J Clin Child Adolesc Psychol. 2002 Sep;31(3):393-8. doi: 10.1207/S15374424JCCP3103_11.
Background: PubMed 26339283Chicchi Giglioli IA, Pallavicini F, Pedroli E, Serino S, Riva G. Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders. Comput Math Methods Med. 2015;2015:862942. doi: 10.1155/2015/862942. Epub 2015 Aug 3.
Background: PubMed 24624073Baus O, Bouchard S. Moving from virtual reality exposure-based therapy to augmented reality exposure-based therapy: a review. Front Hum Neurosci. 2014 Mar 4;8:112. doi: 10.3389/fnhum.2014.00112. eCollection 2014.
Background: PubMed 23173347Gold G, Fazio L, Stolz JH, Herrman FR, Gattelet P, Zekry D. [Assessment of behavior in non-psychiatric settings: use of a simple and reliable method]. Rev Med Suisse. 2012 Nov 7;8(361):2119-21. French.
Background: PubMed 3418327Kay SR, Wolkenfeld F, Murrill LM. Profiles of aggression among psychiatric patients. I. Nature and prevalence. J Nerv Ment Dis. 1988 Sep;176(9):539-46. doi: 10.1097/00005053-198809000-00007.
Individual participant dataSharing planned: 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.

Related trials for Child Behavior Disorders

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
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RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
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Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)

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.

Nordine Benmabrouk, RN study director

Groupe Hospitalier de la Rochelle Ré Aunis

Brigitte Laurent, PhD study director

Ullo World

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Inner Garden in people with Child Behavior Disorders, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site 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 3 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: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Crises (time frame: 8 months after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04610281, which also lists 9 linked publications.

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 Aug 2024.