Randomized Controlled Trial of an Evidence-informed Parenting Intervention to Prevent Violence Against Young Children by Parents and Primary Caregivers in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Change in frequency of child maltreatment (physical and emotional abuse)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult inclusion criteria:
- •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.
- •Child inclusion criteria:
- •Aged 2 to 9 years; and
- •Parent/primary caregiver meets the above inclusion criteria.
- •Inclusion criteria for programme facilitators, who will deliver the PLH for Young Children Thailand programme:
- •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.
排除标准
- •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.
- •Child exclusion criteria:
- •Any child exhibiting acute physical or mental disabilities.
研究组 & 干预措施
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.
干预措施: PLH-Thailand parenting programme (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. 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.
干预措施: Control (care as usual) (Other)
结局指标
主要结局
Change in frequency of child maltreatment (physical and emotional abuse)
时间窗: Differences between groups at T2 (4 months) and T3 (7 months)
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.
次要结局
- Change in frequency of dysfunctional parenting(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))
- 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 attitudes toward punishment(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))
- Change in number of daily child behaviour problems and parenting behaviors(T1: baseline; T2: 1 month; T2: 2 months; T3: 3 months; T4: 6 months)
- 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 child neglect(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))
- Change in frequency of child monitoring and supervision practices(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))
- Change in frequency of child behaviour problems(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))
- Change in number of positive parent-child interactions(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))
- Change in frequency of attitudes towards corporal punishment(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))
- Change in levels of parental depression, anxiety and stress(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))
- Change in frequency of Intimate partner violence(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))
- Change in frequency of parental sense of inefficacy(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))
- Change in frequency of intimate partner negotiation(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))
- Change in frequency of intimate partner coercion(Differences between groups at T2 (4 months) and T3 (7 months), controlling for T1 (baseline))