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Effectiveness of knowledge-based training intervention among mothers for knowledge improvement targeting the prevention of unintentional paracetamol poisoning in children in Rural communities of Batticaloa District in Sri Lanka: A Randomized Controlled Trial

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SLCTR Registration Number

SLCTR/2026/25

Date of Registration

25 Sep 2026

The date of last modification

Sep 25, 2026


Application Summary

Scientific Title of Trial

Effectiveness of knowledge-based training intervention among mothers for knowledge improvement targeting the prevention of unintentional paracetamol poisoning in children in Rural communities of Batticaloa District in Sri Lanka: A Randomized Controlled Trial

Public Title of Trial

Effectiveness of a Knowledge-Based Training Intervention Compared with Usual Care on Mothers’ Knowledge and Practices for the Prevention of Unintentional Paracetamol Poisoning in Children in Rural Communities of Batticaloa District, Sri Lanka: A Randomized Controlled Trial

Disease or Health Condition(s) Studied

Paracetamol poisoning

Scientific Acronym

None

Public Acronym

None

Brief title

Effectiveness of knowledge-based training intervention among mothers for knowledge and practice improvement targeting the prevention of unintentional paracetamol poisoning in children in Rural communities of Batticaloa District in Sri Lanka: A Randomized Controlled Trial

Universal Trial Number

U1111-1344-2996

Any other number(s) assigned to the trial and issuing authority

2025/EC/133;FoM, University of Peradeniya


Trial Details

What is the research question being addressed?

Among mothers of children aged up to 12 years or younger living in rural Batticaloa District, does a structured knowledge-based educational intervention, compared with routine care/no structured education, improve mothers' knowledge and practices regarding the prevention of unintentional paracetamol poisoning over 4 weeks and 6 months?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Single blinded : Outcome assessors

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Prevention

Study Phase

Phase 3

Intervention(s) planned

  1. Study setting: The study will be conducted in two Medical Officer of Health (MOH) areas in Batticaloa District, Sri Lanka. The Vaharai Medical Officer of Health (MOH) area will serve as the intervention cluster, while the Paddipalai MOH area will serve as the control cluster. The predetermined sample size will include 280 eligible mothers, comprising 140 participants in the intervention arm and 140 participants in the control arm. Eligible mothers of children aged 12 years or younger will be recruited from selected Grama Niladhari (GN) divisions within each cluster
  2. Randomization: This is a community-based, cluster randomized controlled trial. The two MOH areas will be randomly allocated to the intervention or control arm to minimize contamination.
  3. Intervention: Participants in the intervention group will receive a structured knowledge-based educational programme on the prevention of unintentional paracetamol poisoning, delivered by the Principal Investigator (PI) at the MOH office using a standardized intervention guide. Sessions will be conducted in groups of approximately 10 participants. The intervention comprises five educational sessions over four weeks (total contact time: 3 hours): one 60-minute session immediately after baseline assessment, followed by four 30-minute weekly reinforcement sessions. Teaching methods include a standardized educational booklet, PowerPoint presentations, educational videos, printed materials, and interactive discussions. The programme covers safe storage, appropriate dosing and administration of paracetamol, recognition of poisoning, immediate first aid, healthcare-seeking behaviour, and prevention strategies. 5.Control: Participants in the control group will receive routine maternal and child health services provided through the existing public health system and will not receive the structured educational programme or study-specific educational materials during the study period. 6.Blinding: This will be a single-blinded cluster randomized controlled trial. Due to the nature of the educational intervention, the Principal Investigator and participants cannot be blinded. However, the outcome assessor and statistician will be blinded to group allocation throughout outcome assessment and data analysis to minimize assessment and analytical bias.

Inclusion criteria

• Mothers aged between 18 and 40 years who have one or more children up to 12 years • Mother who are permanent residents of the selected MOH area will be included in the study.

Exclusion criteria

1.Mothers whose children had one or more chronic illnesses, such as cancer, congenital heart disease, cerebrovascular disease, psychiatric disorders, and hepatic diseases and mothers who stay temporarily for their jobs in these areas will be excluded as they might leave the place at any time.

  1. Mothers who don’t want to give consent for the study are excluded for the study.

Primary outcome(s)

1.

Changes in mothers' mean knowledge and practice scores from baseline to 4 weeks and 6 months post-intervention.

Mean knowledge will be assessed using a validated interviewer administered structured questionnaire and their preventive practices will be assessed using standardized scenario-based checklists.

Differences in changes in mean knowledge and practice scores over time will be calculated and compared between the intervention and control groups. Comparisons will also be made between groups by comparing the differences in mean scores between the intervention and control groups at pre and post intervention at 4 weeks and 6 months.

 [

Outcomes will be assessed at baseline (pre intervention), 4 weeks, and 6 months of (post intervention) in both the intervention and control groups.

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Secondary outcome(s)

1.

None

 [

None

]

Target number/sample size

280 (140 in each control and intervention arms)

Countries of recruitment

Sri Lanka

Anticipated start date

2026-10-01

Anticipated end date

2026-12-30

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

Global Research Academy of Clinical Toxicology (GRACT), University of Edinburg, UK.

Regulatory approvals

Not applicable


State of Ethics Review Approval

Status

Approved

Date of Approval

2026-06-16

Approval number

2025/EC/133

Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Peradeniya.
Institutional Address:Faculty of Medicine, University of Peradeniya
Telephone:+94 81 239 6361
Email: chairperson.erc@med.pdn.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Vijayakumary Thadchanamoorthy
Prof in Paediatrics
Rainwood Estate, Pillayarady Batticaloa
0652228771
0772320717

vijayakumaryt@esn.ac.lk

Contact Person for Public Queries

Vijayakumary Thadchanamoorthy
Prof in Paediatrics
Rainwood Estate, Pillayarady Batticaloa
0652228771
0772320717

vijayakumaryt@esn.ac.lk

Primary study sponsor/organization

Vijayakumary Thadchanamoorthy
Prof in Paediatrics
Rainwood Estate, Pillayaradi Hospital Road
0772320717

vijayakumaryt@esn.ac.lk

Secondary study sponsor (If any)







Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No

IPD sharing plan description

De-identified individual participant data generated during this trial will not be made available to other researchers or released publicly. Only aggregate study findings will be disseminated through peer-reviewed scientific publications and conference presentations.

Study protocol available

Yes

Protocol version and date

Version-02

Protocol URL

Not yet available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


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