CTRI

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CTRI Number

CTRI/2025/09/095218 [Registered on: 22/09/2025] Trial Registered Prospectively

Last Modified On:

19/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Other (Specify) [Mindfulness techniques Alternative yoga and meditation based interventions]

Study Design

Other

Public Title of Study

Effectiveness of Guided Mindfulness-Based- Interventions (MBI) on Selected Outcomes of Parents of People with selected Neuro Developmental Disorders (NDDs)-

Scientific Title of Study

Effectiveness of Guided Mindfulness-Based- Interventions (MBI) on Mindfulness and Selected Outcomes of Parents of People with selected Neuro Developmental Disorders (NDDs)- A Quasi-Experimental Community-Based Study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
nil	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	NISHA LAILA
Designation	PhD Scholar
Affiliation	IIHMR University
Address	IIHMR University, Prabhu Dayal Marg,Rajasthan PhD Scholar IIHMR University Jaipur Rajasthan India Jaipur RAJASTHAN 302033 India
Phone	08860784830
Fax	NIL
Email	nirala786nishi@gmail.com

Details of Contact Person
Scientific Query

Name	Dr.Tripti Bisawa
Designation	Professor, IIHMR-U
Affiliation	IIHMR University
Address	IIHMR University, PRABHU Dayal Marg, Jaipur, Rajasthan PhD Scholar IIHMR University Jaipur Rajasthan India Jaipur RAJASTHAN 302033 India
Phone	8875500082
Fax
Email	tripti@iihmr.edu.in

Details of Contact Person
Public Query

Name	NISHA LAILA
Designation	PhD Scholar
Affiliation	IIHMR University
Address	IIHMR University, Prabhu Dayal Marg, Jaipur, Rajasthan, India PhD Scholar IIHMR University Jaipur Rajasthan India Jaipur RAJASTHAN 302033 India
Phone	08860784830
Fax
Email	nirala786nishi@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	NISHA LAILA
Address	PhD Scholar,IIHMR University,Jaipur, Rajasthan India, 302033
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
NISHA LAILA	Action For Autism (AFA, Open Door School	Action For Autism Open Door School Pocket 7 Jasola New Delhi New Delhi DELHI	8860784830 nirala786nishi@gmail.com
MsNisha Laila	TAMANA Autism Centre School of Hope	C.P.W.D Complex Near Chinmaya Vidhyalaya Vasanth Vihar New Delhi 110057 New Delhi DELHI	8860784830 nirala786nishi@gmail.com

Details of Ethics Committee

No of Ethics Committees= 3
Name of Committee	Approval Status
Institutional Review Board IIHMR UNIVERSITY, JaipurIHMR UNIVERSITY JAIPUR	Approved
IRB TAMANA AUTISM CENTRE NEW DELHI	Approved
IRBACTIONFORAUTISMNEW DELI	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Parents of people with selected NDDs Such as autsim, ADHD, Intellectual disabilities

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	No intervention	Only receiving parent -child training at the centers as standard therapy
Intervention	Guided Mindfulness based Interventions	Mindfulness online training (Integrated mind body training ) will be provided to eligible parents who meets the inclusion criteria for a period of 8 weeks duration (Total 16 hrs,(16 days) weekly 2 hr sessions by a mindfulness trainer expert in the mindfulness and yoga field).The adherence to the training Programme is ensured by frequent reminders and home practice videos shared by parents weekly).The mindfulness interventions are a combination of different meditation techniques and body scan, breathing exercises, guided meditation and chanting mantras,Basic meditation exercise: mindfulness is having the experience without thoughts, meditation on mindful breathing, conscious returning of attention to the breath when the mind wanders away.The training program named as Program Name: Mindful Parenting in Neurodivergence: A Resilience & Healing Journey

Inclusion Criteria

Age From	25.00 Year(s)
Age To	55.00 Year(s)
Gender	Both
Details	1.Parents of children more than 2 years of age, parents of adolescents (14-18), and young adults (19 years to 30years) formally diagnosed with NDDs such as ASD, ADHD &other intellectual disabilities for more than one year. 2.Parents of who are attending for special training and education for their children and adolescents & parents of young adults who are primary care givers of people with selected NDDs. 3.Included both mothers and fathers eligible for the study. 4.Parents who can understand and speak Hindi and English 5.Parents who are willing to participate in a scheduled Mindfulness Based Intervention Programme online mode for 8weeks duration (2 sessions (1-1.5 hrs) per week for total 8 weeks)-16 hrs and there is flexibility in the weekly schedule for the training. 6.Parents who are able to follow Mindfulness meditation techniques 7.Parents who are physically not challenged.

ExclusionCriteria

Details

1. Parents with severe mental health challenges
2.Grand-parents who are caregivers of people with selected NDDs
3. Parents previously attended mindfulness training programs
4.Parents who are already engaged in other psychological therapies
5.Parents taking psychiatric medications, especially for severe depression.
6.Parents experiencing physical problems that would be worse by mindful techniques.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Reduction of Psychological distress (stress, anxiety, depression), improved levels of mindfulness skills, improvement in Interpersonal Mindfulness in parenting, Increased psychological well-being & improved Self-compassion for parents people with Selected Neuro Developmental Disorders such as Autism,ADHD &Other intellectual Disabilities after the Mindfulness based training intervention	8 months

Secondary Outcome

Outcome	TimePoints

NIL	NIL

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)

01/03/2026

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="8"
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 - NO

Brief Summary

The main Aim of the study is to investigate the effectiveness of guided mindfulness Interventions training on mindfulness skills and selected outcomes for parents of people with selected Neuro Developmental Disabilities (NDDs) such as Autism Spectrum Disorder, ADHD (Attention Deficit Hyperactivity Disorder) &Other intellectual disabilities.The study settings selected were two major N.G.O s working for people with Autism and neurodevelopmental disabilities located in New Delhi, Namely Action For Autism ,Open Door school & TAMANA Centre for people with Neuro neurodevelopmental disabilities, New Delhi. The major expected outcomes of this study will be level of mindfulness skills, mindfulness parenting skills, Psychological distress (stress,anxiety and depression), psychological wellbeing, and self compassion for parents.The training will be online mode by an expert mindfulness trainer for 2 months (weekly 2 sessions 1-1.5 hrs for a total of 16 hrs, 8weeks ) and a pretest and post test will be conducted.

The main interventions in this training program are different mindfulness techniques (Mindfulness of thought process, mindfulness of emotion, mindfulness of perception and guided meditation, and breathing exercises) in the form of integrated mind-body meditation as per the training module for parents.There will be a comparison group (receiving only parent-child training at study settings) to compare the outcomes with the intervention group

In this study parents are not undergoing any additional training for their mental health and wellbeing.

The study Design adopted is a Non non-equivalent Quasi-experimental two-group design with a comparison group (pretest-posttest design).

The expected sample size for the two groups will be 44 parents of people with Selected NDDs according to eligibility (Sample size determined from previous similar studies)

The study will be conducted after obtaining ethical approval from the Institutional review Board,IIHMR University, & Permission letters already obtained from respected study settings ,Action For Autism & Tamana Autism centre, New Delhi.

Recruitment for the sample in this study has not yet begun. The recruitment will be starting after obtaining Ethical clearance from IIHMR University,Jaipur