| CTRI Number |
CTRI/2025/11/098046 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An experiment to see if a training is useful to support parents in reducing problem behaviours shown by their children with autism in India |
|
Scientific Title of Study
|
Co-design and open trial of a parenting programme for autistic adolescents in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Karuppasamy |
| Designation |
Assistant Professor |
| Affiliation |
Government Rehabilitation Institute for Intellectual Disabilities (GRIID) |
| Address |
Government Rehabilitation Institute for Intellectual Disabilities (GRIID), Sector, 31-C, Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9865407772 |
| Fax |
|
| Email |
karuppasamy7772@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arush Goel |
| Designation |
PhD Candidate |
| Affiliation |
University of Auckland |
| Address |
Desk 025, Building 507, Level 1, 22-30 Park Avenue, Grafton, Auckland 1023
Not Applicable
N/A
1023
Other |
| Phone |
|
| Fax |
|
| Email |
arush.goel@auckland.ac.nz |
|
Details of Contact Person
Public Query
|
| Name |
M Karuppasamy |
| Designation |
Assistant Professor |
| Affiliation |
Government Rehabilitation Institute for Intellectual Disabilities (GRIID) |
| Address |
Room no. 302, Block C, 3rd Floor, Government Rehabilitation Institute for Intellectual Disabilities (GRIID), Sector, 31-C, Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9865407772 |
| Fax |
|
| Email |
karuppasamy7772@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Rehabilitation Institute for Intellectual Disabilities (GRIID), Sector, 31-C, Chandigarh, 160047 |
|
|
Primary Sponsor
|
| Name |
Arush Goel |
| Address |
Department of Psychological Medicine, Faculty of Medical and Health Sciences, 22-30 Park Avenue, Grafton, Auckland 1023, New Zealand
|
| Type of Sponsor |
Other [University of affiliation of the PhD candidate, Arush Goel] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Hiran Thabrew |
Department of Psychological Medicine, Faculty of Medical and Health Sciences, 22-30 Park Avenue, Grafton, Auckland 1023, New Zealand |
| Prof Trecia Wouldes |
Department of Psychological Medicine, Faculty of Medical and Health Sciences, 22-30 Park Avenue, Grafton, Auckland 1023, New Zealand
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Karuppasamy |
Government Rehabilitation Institute for Intellectual Disabilities (GRIID) |
Room no. 302, Block-C, 3rd floor, Department of Spcial Education, Government Rehabilitation Institute for Intellectual Disabilities (GRIID), Sector, 31-C, Chandigarh, 160047
Chandigarh
CHANDIGARH |
9865407772
karuppasamy7772@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Rehabilitation Institute for Intellectual Disabilities Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No condition. Participants will be parents of autistic adolescents. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Building Bridges Triple P parenting intervention |
The Building Bridges Triple P program will consist of five 120-minute group sessions and three 30-minute telephonic sessions. All sessions are held over eight consecutive weeks (one session each week). The topics covered during the sessions include understanding positive parenting, encouraging and teaching appropriate behaviour, managing problem behaviour, getting their children connected and teaching survival skills. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The sample will include parents only. The inclusion criteria is as follows -
Parents of adolescents aged 12-19 years who have received a diagnosis of autism (through ICD-10, including 84.0, F84.1, F84.5, F84.9, through ICD-11:6A02) by a clinician (psychiatrist, paediatrician, or clinical psychologist)
Parents reporting problem behaviour (including but not limited to irritability, aggression, self-harm, non-compliance, tantrums, etc).
Parents who can read, speak and understand English enough to effectively grasp the content of the training and reliably complete the outcome measures
Parents who have the means to attend the training sessions offline |
|
| ExclusionCriteria |
| Details |
Parents of adolescents aged 12-19 who have received the diagnosis of Rett syndrome, other childhood disintegrative conditions, overactivity, and other pervasive developmental conditions (through ICD-10:F84.2, F84.3, F84.4, and F84.8, through ICD-11:LD90.4)
Evidence of psychosis in adolescents
Parents engaged in any other parent training program or within the last year
Autistic adolescents undergoing intensive Applied Behavioural Analysis program (ABA) or within the last year |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Child problem behaviours measured through likert scale parent self-report measures: Strengths and Difficulties Questionnaire (SDQ; Goodman; 1997) and Child Adjustment and Parent Efficacy Scale - Developmental Disability (CAPESDD; Mazzucchelli, Sanders & Morawska, 2011) |
Pre-intervention, Post-intervention(8-weeks) and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parent confidence and self-regulation measured through liker scale parent self-report measures: Child Adjustment and Parent Efficacy Scale - Developmental Disability (CAPESDD; Mazzucchelli, Sanders & Morawska, 2011) and Parenting Self-Regulation Scales-Parent version (PSRS; Sanders et al., 2017) |
Pre-intervention, post-intervention and three month follow-up |
Feasibility of conducting the trial measured through The ease of recruiting participants and providing them training (based on
the student researcher’s experience), the overall cost involved during the various stages of the
trial (i.e. receiving training in the intervention, cost of material provided to participants, and
cost involved in training the participant), attendance and attrition of participants and time
duration of data collection will be used to assess the feasibility of the open trial |
Post-intervention to 3 month follow-up |
| Acceptability of the intervention measured through quantitative questionnaire - Therapy Attitude Inventory (TAI; Eyberg & Johnson, 1974) and qualitative interviews |
Quantitative measure will be collected post-intervention and qualitative interviews will be conducted at 3-month follow up |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="10"
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
|
This protocol is part of the PhD thesis of Mr Arush Goel, who is an Indian national, currently pursuing his doctoral degree from the University of Auckland, New Zealand. Mr Goel’s PhD is being supervised by Dr Hiran Thabrew (Senior Lecturer, Department of Psychological Medicine, University of Auckland) and Prof. Trecia Wouldes (Head of Department, Psychological Medicine, University of Auckland). I, Dr Karuppasamy, am the Indian collaborator and co-investigator assisting Mr Goel with his data collection at GRIID. This study aims to evaluate a parenting intervention for autistic adolescents with problem behaviours in India.
Health services for families of autistic adolescents in India are limited, as the majority of services focus on early interventions. Problem behaviours, including aggression, non-compliance and irritability, are common symptoms observed in autistic adolescents, and such issues increase the burden of autism on the individual and their families. Traditional therapies like the Applied Behaviour Analysis, although efficacious, pose feasibility issues to access in lower and middle-income countries like India. Hence, parenting interventions offer a scalable and cost-effective alternative for supporting autistic individuals with problem behaviours. Since such interventions have not yet been explored in India, the present study aims to do the same. The study aims to evaluate the feasibility, acceptability and preliminary efficacy of a parenting intervention, the Building Bridges Triple P, for Indian parents with autistic adolescents showing problem behaviour.
In terms of feasibility, the study hypothesises that the trial of such an intervention will be feasible in terms of logistical issues. For acceptability, the study hypothesises that the parenting intervention will highlight good participant and cultural acceptability. Furthermore, the study hypothesises that the parenting intervention, Building Bridges Triple P, will be useful in reducing problem behaviours in autistic adolescents. Secondary to this, it may also improve parental confidence and self-regulation in supporting their child. |