Parenting for Lifelong Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-11

Study Completion Date

2020-02-01

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will use a randomised controlled trial design to test the effects of the Parenting for Lifelong Health 2-9 Thailand programme in comparison to participants allocated to receiving care as usual in the control group (N = 120 parents and primary caregivers of children ages 2 to 9 years; 1:1 intervention to control group ratio).

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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PLH-Thailand parenting programme

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.

Group Type EXPERIMENTAL

PLH-Thailand parenting programme

Intervention Type BEHAVIORAL

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.

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. 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.

Group Type OTHER

Control (care as usual)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.

1. Aged 2 to 9 years; and

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.

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.

Any child exhibiting acute physical or mental disabilities.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes