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临床试验/CTRI/2025/09/095218
CTRI/2025/09/095218
尚未招募
不适用

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

NISHA LAILA2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月1日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
NISHA LAILA
入组人数
100
试验地点
2
主要终点
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

概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Parents with severe mental health challenges 2.Grand-parents who are caregivers of people with selected NDDs
  • 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.

结局指标

主要结局

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

时间窗: 8 months

次要结局

未报告次要终点

研究者

发起方
NISHA LAILA
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

NISHA LAILA

IIHMR University

研究点 (2)

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