Parenting for Lifelong Health - Thailand

University of Oxford

Status: Completed

Conditions: Domestic Violence; Parenting; Depression, Anxiety; Parent Child Abuse; Parent-child Problem; Parent-Child Relations; Child Behavior Problem; Child Neglect

Treatments: Behavioral: PLH-Thailand parenting programme; Other: Control (care as usual)

Study type: Interventional

Funder types: Other

Identifiers

NCT03539341

HCR17011

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Adult inclusion criteria:

1. Men or women aged 18 or older;
2. Serves as the primary caregiver of a child in the household between the ages of 2 and 9;
3. Parent passes the screening interview, based on the Multiple Indicator Cluster Survey (MICS) version 6 module on child discipline;
4. Provides consent to participate in the full study; and
5. Agrees to participate in the PLH for Young Children Thailand parenting programme.

Child inclusion criteria:

1. Aged 2 to 9 years; and
2. Parent/primary caregiver meets the above inclusion criteria.

Inclusion criteria for programme facilitators, who will deliver the PLH for Young Children Thailand programme:

1. Age 18 or older;
2. Prior participation in a five-day facilitator training workshop provided by PLH Trainers; and
3. Agreement to deliver the entire eight session PLH for Young Children Thailand programme.

Adult exclusion criteria:

1. Any adult exhibiting severe mental health problems or acute mental disabilities;
2. Any adult who is unavailable for participation in the PLH for Young Children Thailand programme at time of recruitment;
3. Any adult who has already participated in the feasibility pilot.

Child exclusion criteria:

Any child exhibiting acute physical or mental disabilities.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

PLH-Thailand parenting programme

Experimental group

Description:

Trained facilitators and coaches will deliver the programme over eight weekly sessions at the Udon Thani Regional Hospital during the feasibility pilot and the RCT. During the RCT, the 60 parents/primary caregivers in the intervention group will be divided into 4 groups of 15 participants, with each group overseen by 2 facilitators and 1 coach. Core session activities may include discussion about assigned home activities, core parenting principles, illustrated stories, role-plays, and problem solving. Home visits will be conducted by facilitators to those parents/primary caregivers who miss sessions or require additional support, and SMS/LINE messages will be delivered to all participants twice per week with relevant parenting tips and reminders to attend the upcoming session.

Treatment:

Behavioral: PLH-Thailand parenting programme

Control (care as usual)

Other group

Description:

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. The delivery of services at Parent Schools are guided by the Ministry of Public Health Handbook for Parent Schools, which appear to be open to adaptation at the local level. At Parent Schools, three to five sessions are provided to parents in groups or one-on-one by hospital health personnel.

Treatment:

Other: Control (care as usual)