Pilot design: The feasibility pilot of PLH for Young Children in Thailand has a single-site, pre-post design with no control group, with the aims of assessing programme implementation, cultural and contextual relevance, and study feasibility. Although there is no comparison group and it is not designed to test effects, the pilot also has a provisional goal of reductions in child physical and emotional abuse at one-month post-intervention. RCT design: The RCT of PLH for Young Children Thailand is a randomized, controlled, observer-blinded, single-site trial with two parallel groups and a primary endpoint goal of reductions in child physical and emotional abuse at one month and three-months post-intervention. Randomisation will be performed at the individual level with a 1:1 allocation ratio. Allocation: Using a 1:1 allocation ratio, the 120 participants will be randomly assigned to either the intervention or control group using the concealed computerized programme Sealed Envelope. An external researcher based at the Department of Social Policy and Intervention at the University of Oxford, and who is not directly involved in the study, will generate the random sequence. The Project Coordinator and Co-Investigator McCoy will notify participants of their allocation status via telephone following the collection of baseline data, in order to ensure that participants remain blind to their status during the initial assessment. Blinding: Due to the involvement of facilitators and coaches in the delivery of the programme, blinding will not be possible for deliverers; moreover, participants cannot be blinded to their allocation status following the initial assessment. However, the allocation status of other participants will be kept concealed from participants in order to reduce the risk of contamination. Data collectors gathering outcome and process evaluation data, as well as statisticians providing support in data analysis, will be blinded to participant allocation status for the purposes of minimizing assessment bias. Cases of compromised blinding will be immediately reported to the Research Manager, who will consult with the research team on an appropriate course of action. Un-blinding of participants will only be permitted if any instances of significant harm due to participation in the study are reported by a participant or any member of the project team at any stage of the study. This study is funded by the United Nations Children's Fund (UNICEF) Thailand and the Department of Social Policy and Intervention, University of Oxford. UNICEF grant reference: PCA/THLC/2017/002
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in frequency of child maltreatment (physical and emotional abuse)
Timeframe: Differences between groups at T2 (4 months) and T3 (7 months)