| CTRI Number |
CTRI/2025/05/087950 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Parental Empowerment Through Active Listening Support (PETALS) on selected parenting outcomes and quality of life among parents of children with developmental delay.
|
|
Scientific Title of Study
|
A mixed method study to evaluate the effect of Parental Empowerment Through Active Listening Support (PETALS) on selected parenting outcomes and quality of life among parents of children with developmental delay.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GEETHU BABY |
| Designation |
PhD Scholar |
| Affiliation |
Bishop Benziger College of Nursing , Kollam |
| Address |
PhD Scholar
Dept. of Child Health Nursing Bishop Benziger College of Nursing
Kollam
Pin - 691001
Kollam
KERALA
691001
India |
| Phone |
8129954939 |
| Fax |
|
| Email |
babygeethus@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namitha Subrahmanyam |
| Designation |
Professor |
| Affiliation |
MOSC College of Nursing Kolenchery |
| Address |
Principal
Dept. of OBG Nursing
MOSC College of Nursing
Kolenchery
Pin - 682311
Ernakulam
KERALA
682311
India |
| Phone |
9447421888 |
| Fax |
|
| Email |
namithanijeesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namitha Subrahmanyam |
| Designation |
Professor |
| Affiliation |
MOSC College of Nursing Kolenchery |
| Address |
Principal
Dept. of OBG Nursing
MOSC College of Nursing
Kolenchery
Pin- 682311
Ernakulam
KERALA
682311
India |
| Phone |
9447421888 |
| Fax |
|
| Email |
namithanijeesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Centre
Bishop Benziger College of Nursing
Kollam, India
Pin - 691001 |
|
|
Primary Sponsor
|
| Name |
Geethu Baby |
| Address |
PhD Scholar
Bishop Benziger College of Nursing, Kollam, India
Pin - 691001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Geethu Baby |
Buds School , Pallarimangalam |
Buds School
Pallarimangalam
Muvattupuzha
Ernakulam
KERALA |
8129954939
babygeethus@gmail.com |
| Geethu Baby |
Daya buds school |
Daya Buds School
Nellikuzhi
Muvattupuzha
Ernakulam
KERALA |
8129954939
babygeethus@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Cornmittee Mar Sleeva Medicity Palai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
parents of children with developmental delay |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Routine services given for the participant previously will be continued - information, education |
| Intervention |
Parental Empowerment Through Active Listening Support |
informational empowerment (nutrition, sleep, communication , self care, expression of emotion, attachment), skill training, referral services, telephonic support |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Parents of child with developmental delay
Parents who can understand and communicate in Malayalam or English.
Parents who are willing to share relevant experiences, issues and needs.
Parents of child aged between 2- 10 yrs. |
|
| ExclusionCriteria |
| Details |
Parents of child with co morbidities
Parents with disabilities that incapacitates him/ her to participate in the study like with hearing impairment/ speech impairment.
Parents who already received referral services |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To explore the parenting experiences, issues and needs in caring child with developmental delay.
To design an intervention programme based on the data extracted from the qualitative phase and literature review.
To determine the effect of PETALS on parent-child bonding, parenting self-efficacy, parental satisfaction, parenting stress and quality of life of parents of children with developmental delay. |
1 month post intervention and 3 month post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the relationship between parent - child bonding, parenting self-efficacy, parental satisfaction, parenting stress and quality of life of parents of children with developmental delay.
To determine the association of socio demographic variables with selected parenting outcomes and quality of life of parents of children with developmental delay. |
1 month post intervention and 3 month post intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
09/06/2025 |
| 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="3"
Months="0"
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 is a mixed method study to evaluate the effect of the intervention Parental Empowerment Through Active Listening Support on selected parenting outcomes and quality of life among parents of children with developmental delay. The study will be done in two phases the qualitative phase and quantitative phase. This study intends to evaluate the effect of the intervention Parental Empowerment Through Active Listening Support on parent child bonding, parenting self efficacy, parenting stress, parental satisfaction and quality of life among parents of children with developmental delay. |