| CTRI Number |
CTRI/2025/03/082276 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development and Validation of a Novel Screening Tool for Early Detection of Developmental and Mood Disorders in Children and Adolescents |
|
Scientific Title of Study
|
Development of a new screening tool for early diagnosis of developmental and mood disorders in children and adolescents |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreenivas Rachakonda |
| Designation |
Post Graduate, Paediatrics |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Dept of Paediatrics, Saveetha Medical College and Hospital, Saveetha Nagar,
Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
09008842152 |
| Fax |
|
| Email |
shreenivas.rachakonda30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lal DV |
| Designation |
Professor, Program Director Saveetha CDC, Paediatrics |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Dept of Paediatrics, Saveetha Medical College and Hospital, Saveetha Nagar,
Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7299938038 |
| Fax |
|
| Email |
drlaldv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lal DV |
| Designation |
Professor, Program Director Saveetha CDC, Paediatrics |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Dept of Paediatrics, Saveetha Medical College and Hospital, Saveetha Nagar,
Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7299938038 |
| Fax |
|
| Email |
drlaldv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Kancheepuram district, Tamil Nadu 602105, India |
|
|
Primary Sponsor
|
| Name |
Dr Shreenivas Rachakonda |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Kancheepuram district, Tamil Nadu 602105, 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 |
| Shreenivas Rachakonda |
Saveetha Medical College and Hospital |
Dept of Paediatrics, Saveetha Medical College and Hospital, Saveetha Nagar,
Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu
Kancheepuram
TAMIL NADU |
09008842152
shreenivas.rachakonda30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NORMAL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 1 month to 18 years
2. Availability of a Primary Caregiver or Parent
3. Consent to Participate in the study and the follow – up process |
|
| ExclusionCriteria |
| Details |
1. Children diagnosed Severe Neurological Disorders: Children with epilepsy with uncontrolled seizures, or neurodegenerative disorders that significantly impair communication or cooperation in screening assessments.
2. Children with acute medical illness at the time of screening: Children who are hospitalized or have a severe acute illness at the time of screening will be excluded to avoid confounding effects on behavioral assessment.
3. Children with a prior diagnosis with a fully established psychiatric disorder and undergoing intensive treatment: If a child is already diagnosed with a psychiatric disorder (e.g., schizophrenia, severe bipolar disorder, major depressive disorder) and is undergoing intensive psychiatric treatment (hospitalization, psychotherapy, or multiplepsychotropic medications), they may be excluded to prevent bias in validation.
4. Children with history of developmental regression due to organic causes: Children with documented progressive developmental regression due to metabolic or genetic syndromes that significantly impact cognitive and behavioral function.
5. Children with non-consent from Parent/Guardian |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop and validate a novel screening tool for early detection of developmental, mood, and behavioral disorders in children and adolescents. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Developmental, Mood, and Behavioral Disorders in the study population |
2 years |
|
|
Target Sample Size
|
Total Sample Size="3300"
Sample Size from India="3300"
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)
|
25/03/2025 |
| 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="2"
Months="0"
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 proposed research project aims to develop a novel screening tool for the early diagnosis of developmental and mood disorders in children and adolescents . Early detection of such disorders is crucial for timely intervention, which can significantly improve long-term outcomes for affected children. The screening tool will be designed to be comprehensive yet easy to administer, parent-reported measures to identify early signs of developmental delays and mood disturbances.
This project will involve several phases, starting with an extensive review of existing screening tools and current literature to identify gaps and areas for improvement. The next phase will focus on the design and development of the new tool, leveraging the latest advancements in developmental psychology and pediatric psychiatry. The tool will undergo rigorous validation through pilot studies involving diverse populations to ensure its accuracy, reliability, and cultural sensitivity.
Ultimately, the goal of this project is to create an effective, widely applicable screening tool that can be used by healthcare professionals and educators to facilitate early diagnosis and intervention. By identifying developmental and mood disorders at an earlier stage, the tool will help to provide children with the necessary support and resources to enhance their developmental trajectories and overall well-being. |