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CTRI Number  CTRI/2025/03/082787 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   PSYCHOSOCIAL MANAGEMENT OF INTERNALIZING DISORDERS IN CHILDREN OF PATIENTS WITH MOOD DISORDERS 
Scientific Title of Study   Internalizing disorders and their psychosocial management in children of patients with mood disorders 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varsha Vidyadharan  
Designation  Associate Professor 
Affiliation  Government Medical college Kozhikode 
Address  Department of Psychiatry Government Medical college Kozhikode
Department of Psychiatry Government Medical college Kozhikode
Kozhikode
KERALA
673008
India 
Phone  09497392260  
Fax    
Email  drvarshavinu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Harish MT 
Designation  Professor 
Affiliation  Government Medical college Kozhikode 
Address  Department of Psychiatry Government Medical college Kozhikode
Department of Psychiatry Government Medical college Kozhikode
Kozhikode
KERALA
673008
India 
Phone  9847280957  
Fax    
Email  drharishmt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Varsha Vidyadharan  
Designation  Associate Professor 
Affiliation  Government Medical college Kozhikode 
Address  Department of Psychiatry Government Medical college Kozhikode
Department of Psychiatry Government Medical college Kozhikode
Kozhikode
KERALA
673008
India 
Phone  09497392260  
Fax    
Email  drvarshavinu@gmail.com  
 
Source of Monetary or Material Support  
Government medical college, Kozhikode 673008 Kerala India 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [] 
 
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 
Dr Varsha Vidyadharan  Government Medical College Kozhikode  Department of Psychiatry Government Medical College Kozhikode
Kozhikode
KERALA 		 9497392260

drvarshavinu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT MEDICAL COLLEGE KOZHIKODE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F938||Other childhood emotional disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  psycho social module development  module applied to children with internalizing disorders and assessed for improvement one month post intervention 
Comparator Agent  single arm trial,not applicable  NA 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Children aged 6-17 years whose parents (aged 21-60 years) have mood disorders.

Parents and children providing consent/assent.
 
 
ExclusionCriteria 
Details  Comorbid psychiatric conditions in parents
(e.g., substance use disorders).
Neurological, medical conditions, or sensory disabilities in children.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
prevalence of internalizing disorders among children of patients with mood disorders obtained and psychosocial management module created,post intervention after one month assessed  at the end of 1 month after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
to watch for improvement one month post module based interventions  one month after intervention 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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   N/A 
Date of First Enrollment (India)   01/04/2025 
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="0"
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 (Others) -  all data collected as part of study

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response (Others) -  all support information is shared
  3. Who will be able to view these files?
    Response (Others) -  any one interested to view the phd thesis

  4. For what types of analyses will this data be available?
    Response (Others) -  to complete phd thesis

  5. By what mechanism will data be made available?
    Response (Others) -  mail id used

  6. For how long will this data be available start date provided 01-04-2025 and end date provided 13-12-2027?
    Response (Others) -  till completion of phd study

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   to develop a psychosocial management module for intervention among children with internalizing disorders and then to administer this module to identified children and monitor for improvement after one month post intervention the study will be conducted in three phases first prevalence estimation of internalizing disorders among children of parents with mood disorders and then module development with content validation and then module application in these children basically behavioral intervention and again scales will be re applied which was done earlier for prevalence estimation and look for improvement.  
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