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CTRI Number  CTRI/2014/11/005179 [Registered on: 05/11/2014] Trial Registered Retrospectively
Last Modified On: 05/11/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of a psychological treatment on the mothers explanations about the cause of intellectual disability in children and adolescents. 
Scientific Title of Study   A randomized control trial to study the effect of a structured psychosocial intervention on the explanatory models of the primary caregivers of children and adolescents with intellectual disability. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushila Russell nee Edwardraj 
Designation  Reader 
Affiliation  Christian Medical College 
Address  Child & Adolescent Psychiatry unit Department of Psychiatry Christian Medical College Bagayam Vellore India
Department of Psychiatry Christian Medical College Bagayam Vellore Tamil Nadu 632002
Vellore
TAMIL NADU
632002
India 
Phone  9443623638  
Fax  04162262268  
Email  sushila.russell@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Sushila Russell nee Edwardraj 
Designation  Reader 
Affiliation  Christian Medical College 
Address  Child & Adolescent Psychiatry unit Department of Psychiatry Christian Medical College Bagayam Vellore India
Department of Psychiatry Christian Medical College Bagayam Vellore Tamil Nadu 632002
Vellore
TAMIL NADU
632002
India 
Phone  9443623638  
Fax  04162262268  
Email  sushila.russell@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Sushila Russell nee Edwardraj 
Designation  Reader 
Affiliation  Christian Medical College 
Address  Child & Adolescent Psychiatry unit Department of Psychiatry Christian Medical College Bagayam Vellore India
Department of Psychiatry Christian Medical College Bagayam Vellore Tamil Nadu 632002
Vellore
TAMIL NADU
632002
India 
Phone  9443623638  
Fax  04162262268  
Email  sushila.russell@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Fluid research grant, Christian Medical College, Vellore, India 
 
Primary Sponsor  
Name  Christian Medical College 
Address  Christian Medical College,Bagayam,Vellore,Tamil Nadu, India- 632002 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
KSJacob  Professor, Department of Psychiatry, Christian Medical College, Vellore, India- 632002 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sushila Russell nee Edwardraj  Child & Adolescent Psychiatry unit , Department of Psychiatry,  Christian Medical College,Bagayam, Vellore,India 632002
Vellore
TAMIL NADU 		 9443623638
04162262268
sushila.russell@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board (Research and Ethics Committee), Christian Medical College, Vellore, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Healthy primary care-givers of children with Intellectual Disability,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard care alone  Standard care (parent training program) only for 12 weeks. 
Intervention  Structured Psychosocial Intervention plus standard care (parent training program)  2 hour sessions of Psychosocial intervention in 12 weeks plus Standard care (parent training program) for 12 weeks. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Primary caregiver defined as a biological mother of children with intellectual disability between 2 to 18 years and
enrolled in the parent training program.

Intellectual disability defined as IQ below 70 as assessed on any standardized test of intelligence.
 
 
ExclusionCriteria 
Details  Psychiatric morbidity in primary caregiver.
Severe sensory impairments or psychiatric problem in child.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Explanatory model: mean score  12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Family stress:mean score

Beliefs and values:mean score

Behavior problems:mean score
 		 12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   28/01/2011 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a randomized control trial to study the effect of a structured psychosocial intervention on the primary caregivers of children with intellectual disability ,who are enrolled in a 12 week parent training program.The primary outcome measure will be the primary caregivers explanatory  models .The secondary outcomes will be the primary caregivers spiritual beliefs ,family stress and child’s behavior problems.
 
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