Effectiveness of Prosocial-orientated Acceptance and Commitment Training (PACT) Programme for Parents of Children With Special Health Care Needs in Response to Outbreaks of Novel Infectious Disease: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 3
- 主要终点
- Parental mental well-being
研究概览
简要总结
This randomised controlled trial aims to determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence and family functioning with parents of children with special health care needs as well as the mental well-being of parent-child dyads over 12 months follow-up.
详细描述
Background: The caregiving burden experienced by parents of children with special health care needs (SHCN) is known to be significant, and its impact tends to be exacerbated when an outbreak of a novel infectious disease occurs. As shown in this coronavirus (COVID-19) pandemic, with the prolonged disruptions of individualised rehabilitation/supporting services which cannot be substituted by digital/remoted format and the unprecedented economic hardship, many parents of children with SHCN are under psychological distress, affecting parenting behaviours and child well-being. Existing interventions in literature only serve for suspected/infected cases/healthcare workers. Many interventions were developed without a conceptual understanding of what/how the proposed active/therapeutic ingredient(s)/process(es) could lead to desired outcomes. This study informs the development of a conceptual model, showing that two psychological constructs, namely psychological flexibility (a therapeutic process measured in Acceptance and Commitment Therapy) and prosociality (an attitude and/or behaviour that orient(s) toward the welfare of others and society) played significant roles in mitigating the adverse impact of COVID-19 on parental mental health.
Objectives: To determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence of parents and family functioning parents of children with SHCN as well as the mental well-being of parent-child dyads over 12 months follow-up.
Hypotheses to be tested: When compared to the Control Group, the participation in the PACT programme could improve parental mental well-being, child mental well-being, parental psychological flexibility and parental prosociality, parenting competence and family functioning at immediate, 3-, 6- and 12 months after the completion of the programme.
Design and subjects: A randomised controlled trial with a blinded, two-arm, repeated-measures design; 196 Cantonese-speaking parents/caregivers of children with special health care needs.
Study Instruments: Validated questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The randomisation procedure will be carried by a clerical staff who has no involvements in this project. For parents, all participants will use the same mobile app tentatively branded as "Calm Parents" but receive different assigned contents of the app.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cantonese-speaking Hong Kong residents
- •Living together with the child who is at preschool/school-age (3-8 years old)
- •Caregivers who adopted the responsibility of taking care of the child,
- •has daily access to their iPhone and Android smartphones.
- •In addition, potential eligible parents who respond "yes" to any of the five validated screening questions in the Children with Special Health Care Needs (SHCN) Screener (see https://www.childhealthdata.org/docs/cshcn/technical-summary-of-cshcn-screener.pdf) will then be asked the associated follow-up questions to determine whether the child possesses physical, neurodevelopmental/emotional problem(s) that has lasted for at least 12 months. Only children with a positive response(s) to ≥ 1 item in each of the associated follow-up questions will be classified as children with SHCN.
排除标准
- •Parents who have diagnoses of severe mental illness or developmental disabilities, such as intellectual disabilities
研究组 & 干预措施
PACT Group
A combination of 6 online modules and 4 group-based video conferencing sessions of Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice via a mobile app across 12 weeks
干预措施: Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice (Behavioral)
Control Group
A combination of 6 online modules and 4 group-based video conferencing sessions of daily parenting challenges in caring for a child with SHCN plus positive parenting advice via a mobile app across 12 weeks
干预措施: Positive parenting advice (Behavioral)
结局指标
主要结局
Parental mental well-being
时间窗: Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
The 14-item Mental Health Continuum Short Form for Adults (MHC-SF) will be used to assess the emotional, social and psychological well-being of parents. MHC-SF can be scored between 0 and 5 (6 points Likert scale), which means that the total score on the scale can range from 0 to 70 points. Higher scores indicate a higher level of emotional wellbeing. scaleThe MHC-SF subscales possessed good convergent validity and internal consistencies in Western populations (Lamers et al., 2011).
Child mental well-being
时间窗: Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
The 25-item Strengths and Difficulties Questionnaire (SDQ, 25 items, 3-point Likert scale) will be adopted to evaluate the psychological adjustment of children with SHCN, in terms of conduct problems, hyperactivity, emotional symptoms, peer problems and prosocial behaviours. A total difficulties score can be generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40. The SDQ is one of the most commonly used proxy reports from parents to assess the psychopathology of their children aged 3-16 years (Lai et al., 2010).
次要结局
- Parental psychological flexibility(Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention)
- Parental prosociality(Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention)
- Parenting competence(Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention)
- Family functioning(Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention)
研究者
Yuen Yu CHONG
Assistant Professor, The Nethersole School of Nursing, CUHK
Chinese University of Hong Kong