Parenting for Lifelong Health - Thailand

NCT03539341 | Completed

• 1 other identifier: HCR17011
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in frequency of child maltreatment (physical and emotional abuse)

  Child maltreatment: physical \& emotional abuse (self-report) Physical abuse (including abusive discipline) and emotional abuse will be measured using 20 items from an adapted and expanded version of the International Society for the Prevention of Child Abuse and Neglect (ISPCAN) Child Abuse Screening Tool-Trial Caregiver version (ICAST-T). The ICAST-T measures parental reports of the incidence of abuse perpetrated against their child over the past month using a frequency score on a scale of 0 to 7, or 8 or more times (e.g., "In the past 4 weeks, how often did you discipline \[Child Nickname\] by pushing, grabbing, or kicking him/her?"). This study will assess overall indication of previous child abuse (0 = no abuse; 1 = previous abuse), and frequency of overall abuse by summing all of the subscales. An indication of previous child abuse and a higher frequency of overall abuse represents a worse outcome.

  Differences between groups at T2 (4 months) and T3 (7 months)

Secondary Outcomes (17)

• Change in frequency of physical and emotional abuse

  Differences between groups at T2 (4 months) and T3 (7 months)

• Change in number of instances of physical and emotional abuse

  Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)

• Change in frequency of child maltreatment (physical and emotional abuse)

  Differences between groups at T2 (4 months), controlling for T1 (baseline).

• Change in frequency of positive parenting

  Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)

• Change in frequency of dysfunctional parenting

  Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline)

Other Outcomes (8)

• Implementation fidelity

  This outcome measure will be assessed once per week over an 8 week period, during parenting programme delivery.

• Implementation quality

  The outcome measure will be assessed twice during the 8 week period of parenting programme delivery, during week 6 and week 7.

• Adherence/exposure (parents/primary caregivers)

  This outcome measure will be assessed once per week over an 8 week period, during parenting programme delivery.

Study Arms (2)

PLH-Thailand parenting programme

EXPERIMENTAL

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.

Behavioral: PLH-Thailand parenting programme

Control (care as usual)

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. 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.

Other: Control (care as usual)

Interventions

PLH-Thailand parenting programme 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.

PLH-Thailand parenting programme

Control (care as usual) 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.

Control (care as usual)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 18 or older;
• Serves as the primary caregiver of a child in the household between the ages of 2 and 9;
• Parent passes the screening interview, based on the Multiple Indicator Cluster Survey (MICS) version 6 module on child discipline;
• Provides consent to participate in the full study; and
• Agrees to participate in the PLH for Young Children Thailand parenting programme.
• Aged 2 to 9 years; and
• Age 18 or older;
• Prior participation in a five-day facilitator training workshop provided by PLH Trainers; and
• Agreement to deliver the entire eight session PLH for Young Children Thailand programme.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oxford: lead
• Bureau of Inspection, Ministry of Public Health: collaborator
• Regional Health Center 8 in Udon Thani: collaborator
• Udon Thani Regional Hospital: collaborator
• Boromarajonani College of Nursing (Ministry of Public Health): collaborator
• United Nations Children's Fund (UNICEF) Thailand: collaborator
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• University of Cape Town: collaborator

Study Sites (4)

Ban Tat Health Promotion Hospital

Udon Thani, 41000, Thailand

Location

Chiang Pin Health Promotion Hospital

Udon Thani, 41000, Thailand

Location

Kling Kam Health Promotion Hospital

Udon Thani, 41000, Thailand

Location

Na Phu Health Promotion Hospital

Udon Thani, 41000, Thailand

Location

Related Publications (1)

• 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.

  PMID: 34051772 RESULT

Related Links

• Parenting for Lifelong Health - Thailand research project page

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Frances Gardner, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Jamie Lachman, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Sombat Tapanya, PhD

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

• Phaikyeong Cheah, PhD

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 29, 2018
• Study Start: December 11, 2018
• Primary Completion: January 31, 2020
• Study Completion: February 1, 2020
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Indefinitely
• Access Criteria: Accessibility of the data will require approval from the study team. The study investigators, led by the PI, will jointly make decisions on whether to supply research data to potential new users. Research data will be deposited in and available in the UK Data Archive solely for non-profit use.

Locations

TH (4)