Parenting for Lifelong Health - Thailand

Summary

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

Conditions

• Parent Child Abuse
• Domestic Violence
• Child Behavior Problem
• Child Neglect
• Depression, Anxiety
• Parent-Child Relations
• Parenting
• Parent-child Problem

Interventions

BEHAVIORAL

PLH-Thailand parenting programme

Parenting programmes include developing positive caregiver-child interaction through child-led play and emotional communication, praise and rewards to encourage positive child behaviour, limit-setting behaviours such as effective instruction giving and establishing consistent household rules, and non-violent discipline strategies to replace harsh parenting and corporal punishment.

OTHER

Control (care as usual)

The control will be an inactive condition of standard care at the time of the intervention. 'Standard care' may include access to Parent Schools in Mother and Child Health clinics at public hospitals, which are provided in some provinces and districts in Thailand.

Sponsors & Collaborators

• Bureau of Inspection, Ministry of Public Health

  collaborator UNKNOWN

• Regional Health Center 8 in Udon Thani

  collaborator UNKNOWN

• Udon Thani Regional Hospital

  collaborator UNKNOWN

• Boromarajonani College of Nursing (Ministry of Public Health)

  collaborator UNKNOWN

• United Nations Children's Fund (UNICEF) Thailand

  collaborator UNKNOWN

• Mahidol Oxford Tropical Medicine Research Unit

  collaborator OTHER

• University of Cape Town

  collaborator OTHER

• University of Oxford

  lead OTHER

Principal Investigators

• Frances Gardner, DPhil · University of Oxford

• Jamie Lachman, DPhil · University of Oxford

• Sombat Tapanya, PhD · Mahidol Oxford Tropical Medicine Research Unit

• Phaikyeong Cheah, PhD · Mahidol Oxford Tropical Medicine Research Unit

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-12-11

Primary Completion

2020-01-31

Completion

2020-02-01

Countries

• Thailand

Study Locations