| CTRI Number |
CTRI/2025/04/084488 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ECLECTIC THERAPY] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study on mothers and their children with autism by giving training to mothers to reduce stress improve mothers wellbeing and quality of life and Improving their children development skills. |
|
Scientific Title of Study
|
Eclectic Therapy on Mothers Psychological Well-Being and Resilience Impacting Skill Development in Their Children with Autism Spectrum Disorder |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sirisha M |
| Designation |
Ph. D Scholar |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and TechnologyJaipur |
| Address |
Department of Clinical Psychology, First Floor, Mahatma Gandhi university of medical sciences and Technology, MGUMST, Jaipur
Department of Clinical Psychology, First Floor, Mahatma Gandhi university of medical sciences and Technology, MGUMST, Jaipur
RAJASTHAN
500072
India |
| Phone |
9177771692 |
| Fax |
|
| Email |
sirisha.psych@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Purty |
| Designation |
Associate Professor and Head, Dept. of Clinical Psychology |
| Affiliation |
Mahatma Gandhi university of medical sciences and Technology Jaipur |
| Address |
Department of Clinical Psychology, First Floor, Mahatma Gandhi university of medical sciences and Technology, MGUMST, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9685677129 |
| Fax |
|
| Email |
sunitarnps9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Purty |
| Designation |
Associate Professor and Head, Dept. of Clinical Psychology |
| Affiliation |
Mahatma Gandhi university of medical sciences and Technology Jaipur |
| Address |
Department of Clinical Psychology, First Floor, Mahatma Gandhi university of medical sciences and Technology, MGUMST, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9685677129 |
| Fax |
|
| Email |
sunitarnps9@gmail.com |
|
|
Source of Monetary or Material Support
|
| cognizance institute of mental health and neurosciences , CIMHANS , plot no 20, A.S Raju nagar, nizampet road , hyderabad ,500090 |
|
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Primary Sponsor
|
| Name |
Sirisha M |
| Address |
Department of Clinical Psychology, First Floor, Mahatma Gandhi university of medical sciences and Technology, MGUMST, Jaipur, Rajasthan, India pin code 302022 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Guru Prasanna Lakshmi Immadi |
cognizance institute of mental health and neurosciences , CIMHANS , |
Plot no 20. AS raju nagar , High tension line road, Nizampet Rd, Kukatpally, Hyderabad, Telangana 500090
Medchal
TELANGANA |
9989585186
cognizance.guru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL, MGUMST, JAIPUR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, (2) ICD-10 Condition: F438||Other reactions to severe stress, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eclectic therapy |
Duration of intervention: 16 weeks intervention
Total number of intervention sessions: 16 sessions
frequency of each intervention session:
weekly one session ,
each session duration 60 minutes - 90 minutes
Details of eclectic therapy intervention:
Eclectic therapy is Multimodal Therapy: a comprehensive, biopsychosocial approach to psychotherapy includes techniques from evidence based therapies like Cognitive behavioral therapy CBT, Acceptance commitment therapy ACT, Dialectical behavioral therapy DBT, Solution focused brief therapy SFBT improving the psychological well-being and resilience of mothers with evidence-based therapeutic approach- Eclectic therapy given to mothers of children diagnosed with autism and focusing parallelly on both mother and child outcomes. mothers who engage in responsive caregiving and training their child by understanding their needs build self-efficacy. Parenting a child with a disability who has autism spectrum disorder (ASD) have special needs, and thus it is more challenging as it demands extra effort. In this process, parents need strong mental health and proper coping strategies to maintain their psychological well-being, especially mothers who are the primary caretakers in the family. Mothers of children with Autism Spectrum Disorder are at risk of psychological distress, if a mother is struggling mentally, emotionally it can be hard to nurture a child with Autism. Because of daily challenging situations in parenting the child mother’s psychological well-being and Resilience is mostly compromised.so along with eclectic therapy ,stress management techniques ,home based training to mothers will be given so that they train their children thus
parental involvement in the therapeutic process can be of great help in increasing social and communication skills in children diagnosed with ASD.
|
| Comparator Agent |
Home based management training |
in this comparator group only, mothers will get home based training to their children. no therapies to mothers in this group |
| Comparator Agent |
stress management therapy |
Counselling,
Simple diaphragmic Breathing Exercises, Basic Coping Strategies, Grounding Techniques supportive Counselling
along with,home based training to mothers will be given so that they train their children to evaluate the outcome and compare with intervention group 1 eclectic therapy
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Mothers aged 25-40 years.
Mothers whose education qualification should be minimum 12th grade
Mothers of children who are recently (more than 1 month and less than 6 months) diagnosed as mild Autism by any rehabilitation & clinical professionals Child can be both male or female
Mothers who are biological parent and primary care taker of children Diagnosed with Autism spectrum Disorder (not adopted or caretaker/guardian).
Both working mothers, non-working mothers, single parenting mothers will be included in the study (The group differences or variances in the results will be later analysed separately)
Mothers having single child and multiple children will also be included in the study (the variances in the results will be analyzed separately)
inclusive criteria for children taken for intervention:
Children aged 3 year – 6 years
Children with Intelligent Quotient ranging from 50 – 69 (Mild level of IQ) will be included in the study.
Children who are diagnosed recently (more than 1 month and less than 6 months) as mild Autism with ISAA tool score ranging 70-106), Child can be both male or female.
children who already got admission to regular schools or special schools or whom not yet enrolled in schools will also be included in the study.
|
|
| ExclusionCriteria |
| Details |
exclusive criteria of mothers Mother with any acute clinical depression or psychiatric condition or physical disability.
Previous experience with any type of therapeutic intervention training or any other type of contemplative or other practices such as ongoing in the previous 6 months.
Mothers of children diagnosed with Autism and along with any Other comorbid conditions are excluded like genetic disorders physical disability or TBI.
exclusive criteria of children
Children whom are under medication for generalized seizures/epilepsy
Children with Autism and along with any Other comorbid conditions, psychiatric conditions are excluded like genetic disorders, physical disability
Previous exposure with any type of therapeutic training ongoing in the previous 6 months.
children who are currently taking any other therapies (Behavior therapy, Occupational therapy, Speech therapy) for more than 1 month.
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Psychological Well being
Resilience |
16th week and 25th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
skill development in children with autism
Behavioral changes
Autism levels |
6 months |
| |
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 1 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Three groups will be made according to the inclusion and Exclusion criteria Experimental Group 1, Experimental group 2 , waitlist or control group
Group A Experimental Group 1 will receive Eclectic therapy+ Stress management techniques + Home-based management training for their children with Autism.
Group B Experimental Group 2 will receive Stress management techniques + Home-based management training for their children with Autism.
Group C Waitlist or control Group will receive only Home-based management training for their children with Autism.
Data will be analyzed with an appropriate statistical too after post assessment 1, 8 weeks of no intervention period will be maintained and post assessment 2 will be conducted. |