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Clinical Trials/CTRI/2025/09/095105
CTRI/2025/09/095105
Not yet recruiting
Not Applicable

Effectiveness of a Brief Parent-Mediated Intervention Program on Parental Knowledge in Parents of Children with Neurodevelopmental Disorders: A One-Group Repeated Measures Design

Christian Medical College1 site in 1 country44 target enrollmentStarted: August 31, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
44
Locations
1
Primary Endpoint
Parental knowledge of symptoms of Neurodevelopmental disorders and their interventions.

Overview

Brief Summary

Neurodevelopmental conditions are a group of disorders that affect brain function, leading to difficulties in learning, behavior, and social interaction. NDDs include autism spectrum disorder ASD, attention-deficit hyperactivity disorder ADHD, and intellectual disabilities, which often emerge in early childhood and can impact daily functioning across the lifespan.

Parenting a child with a neurodevelopmental disorder NDD can be overwhelming, especially when parents lack the knowledge and resources to support their childs needs effectively. Many parents struggle to understand their childs condition, manage behaviours, and access appropriate services, which can create additional stress and prevent children from receiving the interventions they need. We would like to take the pre-intervention assessment at the beginning of the entire 5-day program, and the post-intervention assessment at the end of the entire 5-day program using the VTOP tool. The VTOP tool was found to have the content validity of 0.903 and the face validity of 0.795. In terms of reliability, the internal consistency measured using Cronbachs alpha method was 0.924. The content validity was established through expert review and opinion, and the face validity of the tool has been confirmed, indicating adequate validity. While pilot studies were conducted to assess the usability of the tool, its reliability has not yet been formally studied.

A five-day parent-mediated training program has been designed to provide short-term intervention for parents who attend the sessions with their child everyday. This is primarily aimed at providing parents with knowledge and hands-on skill training on managing their child.

Parent-mediated intervention is strongly recommended as a highly effective approach in paediatric occupational therapy, where 13 percent of reviewed interventions were directly aimed at parents, enabling them to deliver therapy within daily parenting routines at home. This approach leverages parents inherent knowledge of their childrens preferences and engagement styles, along with the substantial caregiving they provide, allowing for increased therapy intensity through home programs and self-management Novak and Honan 2019.

Since the training is short, an observable change in the child is difficult to achieve hence, this study aims to evaluate the effectiveness of this program by assessing changes in parental knowledge before and after the training. Specifically, it also seeks to identify which areas show the most significant progress and determine aspects of the program that may need further refinement. Each childs parent will participate in the training and complete a questionnaire before and after the program to assess their learning. The questionnaire will be scored using a 3-point Likert scale. We have modified the tool by changing the response options to True, False, and Dont know. The scoring key is as follows False or Dont know 1, and True 2. Using this tool, we aim to calculate the change in scores for the pre and post-tests of the VTOP tool.

The study adheres to relevant national and international ethical guidelines, including the Declaration of Helsinki, the Belmont Report, and the ICMR Guidelines. We ensure that no individual is denied access to the intervention, and the intervention is not altered for those who are not participants. Ethical considerations were central to our choice of a quasi-experimental design, as using a controlled experimental design would have required withholding therapy from a group of participants, which we deemed ethically inappropriate.

Since randomization of sessions is not feasible as the sessions follow a protocol based on a hierarchy of information and a predetermined sequence, for the post-test we have instead modified the question order in the assessment tool, to reduce potential recall bias between the pre and post-tests. The areas that will be evaluated are knowledge on NDDs, behaviour management techniques, teaching techniques, task analysis, and sensory-based interventions. The results will be analysed and will lead us to find whether the program causes a significant increase in parental knowledge. If specific topics show minimal improvement, adjustments will be made to enhance future training sessions.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
12.00 Month(s) to 60.00 Month(s) (—)
Sex
All

Inclusion Criteria

  • Parents of children diagnosed with NDD, including ASD, ADHD, learning disability, and Intellectual disability.
  • Parents enrolled in the five-day parent-mediated intervention program.
  • Parents literate in English, Tamil, or Hindi.
  • Parents enrolled for the first time in the five-day program.

Exclusion Criteria

  • Parents who previously attended the 12-week, 6-week, or five-day programs.
  • Parents of children with severe motor comorbidities (e.g., cerebral palsy).

Outcomes

Primary Outcomes

Parental knowledge of symptoms of Neurodevelopmental disorders and their interventions.

Time Frame: T1- pre test | T2- post test

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Ms Teresa Karunya Davis

Christian Medical College, Vellore

Study Sites (1)

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