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

Child Behavior Disorders Clinical Trial

— ESSAIMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04610281
• Other study ID #: 2019/P08/360
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: July 6, 2021

Study information

• Verified date: November 2020
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 6, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Child Behavior Disorders
• Mental Disorders

Intervention

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.)

Locations

Country	Name	City	State
France	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis	Ullo World

Country where clinical trial is conducted

France, 

References & Publications (9)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. French. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	8 months after inclusion
Secondary	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
Secondary	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
Secondary	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