| CTRI Number |
CTRI/2025/01/079003 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative study |
| Study Design |
Other |
|
Public Title of Study
|
Parents Experiences with Autism Spectrum Disorder during puberty |
|
Scientific Title of Study
|
Experiences of parents of children with Autism Spectrum Disorder going through different stages of puberty: A Qualitative exploratory 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 |
Dr Karuna Nadkarni |
| Designation |
In charge And Associate Professor |
| Affiliation |
Seth GS Medical college |
| Address |
Occupational Therapy Department OPD 412 Seth GS Medical college And KEM Hospital Orthopedic centre Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738922552 |
| Fax |
|
| Email |
karunanadkarni@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reshma Bhagat |
| Designation |
Pg student |
| Affiliation |
Seth GS Medical college |
| Address |
Occupational Therapy Department OPD 412 Seth GS Medical college And KEM Hospital Orthopedic centre Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8446619511 |
| Fax |
|
| Email |
reshmabhagat116@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karuna Nadkarni |
| Designation |
In charge And Associate Professor |
| Affiliation |
Seth GS Medical college |
| Address |
Occupational Therapy Department OPD 412 Seth GS Medical college And KEM Hospital Orthopedic centre Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738922552 |
| Fax |
|
| Email |
karunanadkarni@kem.edu |
|
|
Source of Monetary or Material Support
|
| Seth GS Medical college and KEM Hospital Mumbai maharashtra 400012 |
|
|
Primary Sponsor
|
| Name |
Dr Karuna Nadkarni |
| Address |
Occupational Therapy Department OPD 412 Seth GSMC And KEM Hospital Orthopedic centre Mumbai 400012 Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karuna Nadkarni |
Seth GS Medical college |
Occupational Therapy Department OPD 412 Seth GS Medical College and KEM hospital orthopedic centre Mumbai
Mumbai
MAHARASHTRA |
7738922552
karunanadkarni@kem.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC)III Seth GS Medical college and KEM Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Parents/caregivers of children with ASD. |
|
| ExclusionCriteria |
| Details |
Parents of children with ASD with co-morbidity like ADHD, epilepsy or any other medical condition. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To find out Parent’s level of understanding of their child’s puberty.
2.To understand the challenges faced by the parents of children with Autism Spectrum Disorder during their child’s puberty. |
Upto 2 weeks (Baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To explore the ways parents are coping with challenges during puberty of their son or daughter with ASD.
2.To identify parents expectations from healthcare professionals regarding puberty related issue
|
Upto 2 weeks (Baseline) |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Title Experiences of parents of children with Autism Spectrum Disorder going through different stages of puberty: A Qualitative exploratory study.
Aim To explore challenges faced by parents of children with ASD during their child’s puberty.
Objectives 1. To find out Parent’s level of understanding of their child’s puberty. 2. To understand the challenges faced by the parents of children with Autism Spectrum Disorder during their child’s puberty. 3. To explore the ways parents are coping with challenges during puberty of their son or daughter with ASD. 4. To identify parents expectations from healthcare professionals regarding puberty related issue. Study design It is an exploratory qualitative study.
Sampling technique Purposive sampling.
Study setting Data will be collected from parents of ASD children coming to Tertiary care hospital.
Inclusion criteria Parents/caregivers of children with ASD between the age of 8 to 14 years and those who are willing to participate.
Exclusion criteria Parents of children with ASD with co-morbidity like ADHD, epilepsy or any other medical condition.
Methodology Ethics approval. Sample size will be determined by the principle of data saturation. (Saturation of responses) As this is a qualitative study, the sample size needed to reach saturation will be the point at which similar comments would be heard over and over again for a particular question and when no new data is generated with respect to the topic.As per review of literature most of the qualitative studies have sample size up to 12, ,we shall evaluate not less than 15 participants or the number at which saturation is reached whichever is more. Written Consent would be taken from the participants (i.e. parents/primary caregivers) for participation in the study & for audio recordings of the interview. Conduction of the one-on-one semi structured interview would be conducted in a disturbance free environment. A pre validated questionnaire would be used for the interview. All of the interviews will be audio recorded. Once the interview is done, if parents required any help or counseling from the healthcare services then they will be referred to an appropriate healthcare professionals. Verbatim data transcription. Analysis using thematic analysis technique. |