Clinical trial NCT03539341: Parenting for Lifelong Health - Thailand
Official title: Randomized Controlled Trial of an Evidence-informed Parenting Intervention to Prevent Violence Against Young Children by Parents and Primary Caregivers in Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent Child Abuse
Domestic Violence
Child Behavior Problem
Child Neglect
Depression, Anxiety
Parent-Child Relations
Parenting
Parent-child Problem
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Bureau of Inspection, Ministry of Public Health
name: Regional Health Center 8 in Udon Thani
name: Udon Thani Regional Hospital
name: Boromarajonani College of Nursing (Ministry of Public Health)
name: United Nations Children's Fund (UNICEF) Thailand
name: Mahidol Oxford Tropical Medicine Research Unit
name: University of Cape Town
First posted: 2018-05-29
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief 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


Eligibility 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.

Primary outcomes:
measure: Change in frequency of child maltreatment (physical and emotional abuse)
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months)
Secondary outcomes:
measure: Change in frequency of physical and emotional abuse
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months)
measure: Change in number of instances of physical and emotional abuse
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in frequency of child maltreatment (physical and emotional abuse)
timeFrame: Differences between groups at T2 (4 months), controlling for T1 (baseline).
measure: Change in frequency of positive parenting
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in frequency of dysfunctional parenting
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in frequency of child monitoring and supervision practices
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in frequency of child neglect
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in levels of parental depression, anxiety and stress
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in frequency of child behaviour problems
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in attitudes toward punishment
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in number of daily child behaviour problems and parenting behaviors
timeFrame: T1: baseline; T2: 1 month; T2: 2 months; T3: 3 months; T4: 6 months
measure: Change in number of positive parent-child interactions
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in frequency of Intimate partner violence
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in frequency of attitudes towards corporal punishment
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in frequency of parental sense of inefficacy
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in frequency of intimate partner coercion
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
measure: Change in frequency of intimate partner negotiation
timeFrame: Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)
Other outcomes:
measure: Implementation fidelity
timeFrame: This outcome measure will be assessed once per week over an 8 week period, during parenting programme delivery.
measure: Implementation quality
timeFrame: The outcome measure will be assessed twice during the 8 week period of parenting programme delivery, during week 6 and week 7.
measure: Adherence/exposure (parents/primary caregivers)
timeFrame: This outcome measure will be assessed once per week over an 8 week period, during parenting programme delivery.
measure: Engagement in home activities
timeFrame: This outcome measure will be assessed once per week over an 8 week period, during parenting programme delivery.
measure: Satisfaction/acceptability/engagement: quantitative data (parents/primary caregivers)
timeFrame: Quantitative data on engagement & acceptability will be assessed once per week over 8 weeks during programme delivery. Quantitative data on satisfaction will be assessed 7 months post-baseline.
measure: Satisfaction/acceptability (facilitators and coaches)
timeFrame: Once per week over 8 weeks during programme delivery, and at T: 7 months
measure: Programme engagement
timeFrame: Baseline
measure: Satisfaction/acceptability/engagement: qualitative data (parents/primary caregivers)
timeFrame: Once per week over 8 weeks during programme delivery, and at T: 7 months
Locations:
city: Udon Thani
country: Thailand
facility: Ban Tat Health Promotion Hospital
city: Udon Thani
country: Thailand
facility: Chiang Pin Health Promotion Hospital
city: Udon Thani
country: Thailand
facility: Kling Kam Health Promotion Hospital
city: Udon Thani
country: Thailand
facility: Na Phu Health Promotion Hospital
Study officials:
affiliation: University of Oxford
name: Frances Gardner, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Jamie Lachman, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Sombat Tapanya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Phaikyeong Cheah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCoy A, Lachman JM, Ward CL, Tapanya S, Poomchaichote T, Kelly J, Mukaka M, Cheah PY, Gardner F. Feasibility pilot of an adapted parenting program embedded within the Thai public health system. BMC Public Health. 2021 May 29;21(1):1009. doi: 10.1186/s12889-021-11081-4.