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CTRI Number  CTRI/2024/03/064471 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 13/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Integrative Art Therapy for Childrens with Emotional and Behavioural Problems. 
Scientific Title of Study   Development and pilot testing of Integrative Art Therapy Module for Emotional and Behavioural Well-being of Children residing in Children’s home. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Saikia 
Designation  PhD Scholar 
Affiliation  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health 
Address  Department of Psychiatric Social Work, 4th floor, Academic Buiding, LGBRIMH, Tezpur, Assam, 784001
Department of Psychiatric Social Work, 4th floor, Academic Buiding, LGBRIMH, Tezpur, Assam, 784001
Sonitpur
ASSAM
784001
India 
Phone  918136056076  
Fax    
Email  priyankasaikia187@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonia Pereira Deuri 
Designation  Professor and Head of the Department 
Affiliation  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health 
Address  Department of Psychiatric Social Work Academic Buiding LGBRIMH Tezpur Assam 784001

Sonitpur
ASSAM
784001
India 
Phone  9435080843  
Fax    
Email  soniadeuri28@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amaresha C 
Designation  Associate Professor 
Affiliation  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health 
Address  Department of Psychiatric Social Work Academic Buiding LGBRIMH Tezpur Assam 784001

Sonitpur
ASSAM
784001
India 
Phone  9449603952  
Fax    
Email  amarmsw@gmail.com  
 
Source of Monetary or Material Support  
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health 
 
Primary Sponsor  
Name  Priyanka Saikia 
Address  LGBRIMH, Tezpur, Assam 
Type of Sponsor  Other [Priyanka Saikia] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mrs Trishna Mani Laskar  Nabaprabhat Children Home  Ketekibari Road Ketekibari Tezpur Assam 784150
Sonitpur
ASSAM 		 9707775071

NABAPRABHATKETEKIBARI@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, LGBRIMH, Tezpur 784001  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children with emotional and behavioural problems 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrative Art Therapy  The sessions will include topics on different types of facial expressions to understand what children feel about an event, issue, or individual in his/her life and to discover what helps the child to cope with it, Listening to Music to regulate the mood, Blind Walk to build up trust and to facilitate openness towards sharing, Falling and Holding To strengthen the trust while sharing and to help the participants to verbalize their feelings and so on. The total duration of the intervention will be 5 months approximately. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children residing in Children’s home, from 8-18 years of age will be the inclusion criteria. 
 
ExclusionCriteria 
Details  Children with major physical and psychiatric illnesses will be excluded at the time of analysis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
enhancement in Emotional and behavioural wellbeing of the children residing in children home.  1 Baseline assessment
2 Post assessment 
 
Secondary Outcome  
Outcome  TimePoints 
Satisfaction of the participants with the intervention and usefulness of the intervention  Post asssessment 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyankasaikia187@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2030?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - none
Brief Summary  
Emotional and behavioural issues are quite common among children and adolescents, affecting approximately 10% to 20% of them globally. These problems can significantly disrupt daily life and its activities. Children with emotional and behavioral difficulties can be better intervened through the integration of medical and psychosocial treatment modalities. Integrative art therapy has been using various art forms like painting, sculpture, clay, dance, music, drama, digital art, etc. as a means of expression to address inner conflicts and to improve wellbeing. Integrative Art Therapy has gained increasing recognition as an effective intervention for improving emotional and behavioral problems among children and adolescents. Several studies have highlighted the potential of Integrative Art Therapy to enhance emotional and behavioral well-being among children. 
  
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