LOVING (Learning About Our Behavior is Valuable for Increasing Nurturing Relationships and Healthy Growth)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 624
- 试验地点
- 5
- 主要终点
- Differential Change Pre-Post Parental Sensitivity Assessed via the Preschool MBQS (Parent Outcome) Confirmatory: VIPP-SD-SingH more favorable trajectory than NeuroEducation; Exploratory: CARE-SD more favorable trajectory than NeuroEducation
研究概览
简要总结
The LOVING study is a randomized controlled trial designed to determine whether adaptations to an internationally recognized parenting program that enhances sensitive caregiving likewise improves sensitive caregiving in Singapore and, in turn, downstream child outcomes in emotional, behavioral, and cognitive development during the early childhood years.
Research shows that sensitive caregiving is linked to secure relationships, decreased child mental health problems, better executive functioning, and potentially healthier body mass indices. The Video Feedback to Improve Positive Parenting and Sensitive Discipline (VIPP-SD) program is an internationally recognized home-based intervention designed to enhance sensitive caregiving. However, evidence demonstrating its efficacy in Asia remains extremely limited. Moreover, most previous evaluations have focused primarily on parenting or child mental health outcomes, with newer work only beginning to focus upon additional child outcomes.
In this study, families with young children from median-income and below households living in Singapore will be randomly assigned to one of three groups. Some families will participate in a locally adapted version of the home-based VIPP-SD program that includes additional health-related scenarios (VIPP-SD-SingH). Other families will be assigned to CARE-SD, which was developed within the context of proof-of-concept research. CARE-SD is a standardized, digitally delivered parenting program using vicarious pre-rendered video examples and comments derived from the VIPP-SD program and does not include personalized feedback during home visits. Furthermore, CARE-SD includes health related scenarios and language and settings familiar to families living in Singapore. A third group will receive developmental information about children's learning and development (i.e., NeuroEducation Active Control). The programs are brief and are designed to be practical and accessible for families.
Families participating in the study will take part in research visits that include questionnaires, observations of parent-child interaction, and activities designed to assess children's development. Laboratory visits will take place at IHDP (a collaborating institution) research facilities. Information collected in the study will help researchers better understand how parenting support programs influence children's emotional well-being, behavior, learning, and physical health.
The results of this research may help inform the development of effective programs to support families and promote healthy child development.
详细描述
Early childhood is a critical developmental period during which caregiving relationships play an important role in shaping children's social, emotional, cognitive, and physical development. Sensitive caregiving occurs when a caregiver accurately perceives and responds to a child's signal in a timely and appropriate manner. It is associated with secure attachment relationships, fewer child behavioral and emotional difficulties, better executive functioning, and potentially healthier physical development.
Interventions that support sensitive caregiving have therefore been identified as promising approaches for promoting healthy child development and preventing later mental health and behavioral problems.
One of the most widely studied programs designed to enhance sensitive caregiving is the Video Feedback to Improve Positive Parenting and Sensitive Discipline (VIPP-SD) program. VIPP-SD is a brief, home-based intervention that uses video feedback to help caregivers recognize and respond sensitively to their child's cues and to support positive discipline practices. Numerous randomized trials conducted primarily in Europe and North America have demonstrated that the VIPP-SD can improve parental sensitivity and, in several cases, child behavioral outcomes. However, rigorous evaluations of these approaches in Asian contexts remain extremely limited. In addition, most existing studies have focused primarily on parenting and child mental health outcomes, with less attention to broader developmental domains such as executive functioning or physical health.
The LOVING study is a randomized controlled trial designed to evaluate whether an adapted version of the VIPP-SD program (i.e., VIPP-SD-SingH, Video-Feedback Intervention to Promote Positive Parenting and Sensitive Discipline Adapted for the Singapore Context with a Health Component), improves sensitive caregiving and downstream child externalizing (specifically conduct and oppositional defiant symptoms). The RCT will also examine additional child developmental outcomes among families in Singapore in a secondary (i.e., children's executive functioning and adiposity) and/or exploratory capacity.
The study will furthermore provide an exploratory proof of principle investigation of whether a standardized, digitally delivered parenting program using vicarious pre-rendered video examples and comments derived from the VIPP-SD program, which does not include personalized feedback during home visits, but like the VIPP-SD-SingH incorporates Singaporean experience and health related contexts, produces benefits relative to an active control. That is, this study's investigations involving CARE-SD (i.e.,Caregiver Awareness of Relationships through E-learning for Sensitivity and Discipline) will provide additional acceptability and feasibility information beyond that obtained in earlier LOVING research and preliminary proof-of-principle efficacy information.
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)
盲法说明
In addition to the Investigators and Outcomes Assessors, laboratory staff will not be told the assigned group and participants will be asked not to reveal their grouping to laboratory staff. Should participants inadvertently do so, staff will inform the scheduler who will take note and/or ensure that the staff member does not see the family for subsequent laboratory visits. VIPP-SD-SingH interveners will not be involved in scoring the parent-child interaction data for the families with whom they have been assigned to conduct the VIPP-SD-SingH, and so will be "blind" to treatment group as they score interactions. At a minimum, datasets used for confirmatory analyses, as well as those comparing CARE-SD and the NeuroEducation control on MBQS sensitivity, PAPA ODD-conduct, MEFS executive function, and BMIz will be labeled using anonymized group codes (e.g., A, B, C), with analysts blinded to treatment allocation until relevant analyses are complete.
入排标准
- 年龄范围
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children must be 2 to 5.5 years of age at their pre-test visit. Children with a medical or developmental condition that makes it hard for them to see, hear, move, or communicate in typical ways (for example, autism spectrum disorder, down syndrome, spina bifida, or serious vision or hearing problems) will not be eligible to participate. This is because the study focuses on everyday patterns of parent-child interaction. Children with minor or symptom-free medical or genetic conditions (for example, traits that do not affect their day-to-day health or development) can take part.
- •Parents must be between 21 and 65 years old at the time of consent. Mothers and fathers who consider themselves to have a major caregiving role are eligible. Parents who have been hospitalized for more than two weeks (inclusive) within the past 6 months and/or have had any in-patient mental health treatment within the past 6 months may not participate, nor may parents with notable neurodegenerative diagnosis such as Alzheimer's, Parkinson's, or Huntington's disease.
- •Participants must be from families earning near to Singapore's median household income or below, provided recruitment and enrollment difficulties have not triggered a pre-defined rule leading to the omission of this requirement. Parents and children must be able to communicate in English, Mandarin, Bahasu Melayu, and/or Tamil. Participants must also be willing to be audio-video recorded and amenable to random assignment.
排除标准
- 未提供
结局指标
主要结局
Differential Change Pre-Post Parental Sensitivity Assessed via the Preschool MBQS (Parent Outcome) Confirmatory: VIPP-SD-SingH more favorable trajectory than NeuroEducation; Exploratory: CARE-SD more favorable trajectory than NeuroEducation
时间窗: Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session
Change in parental sensitivity will be evaluated from video records of four dyadic interactions, totaling roughly 25 minutes of behavior per relevant lab visit. Trained coders will apply the Preschool MBQS (Pederson et al, 2013; Tarabulsy 2009), a 25-item forced q-sort to interactions. The interactions themselves will proceed in a set order beginning with a parent-child snack, obedience task, hopscotch-like game, and sticker-by-art activity. These will be included for relevance to obedience and the physical health related aspects in the VIPP-SD-SingH and CARE-SD programs (i.e., feeding/nutrition; physical activity/movement; rest/relaxation). Tasks are likely amenable to engaged interaction but also do not explicitly require it. Instructions will be delivered on notecards, to ensure consistency and also some divided attention. In principle, all tasks can be conducted in a developmentally appropriate manner. 20% will be independently coded.
Differential Change in Pre-Post PAPA Assessed ODD/Conduct Symptom Count (Child Outcome) Confirmatory: VIPP-SD-SingH more favorable trajectory than NeuroEducation; Exploratory: CARE-SD more favorable trajectory than NeuroEducation
时间窗: Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session
Parents will be interviewed by trained staff using modules from the "The Preschool Age Psychiatric Assessment (PAPA): A structured parent interview for diagnosing psychiatric disorders in preschool children" (see Egger et al., 2019). The outcome used in primary analyses will be the sum of the Oppositional Defiant Disorder (ODD) and Conduct Problems (CD) symptom counts (maximum score = 17). ODD symptoms will be assessed with regards to a "primary period" (e.g., 3 months) and require a minimal frequency to be met, which varies by symptom and is adjusted by age (as per the DSM5). CD symptom criteria are more varied, with some variables requiring only one occurrence, which in some cases can happen outside the primary period. In such cases, we will also collect occurrence within the last three months to better examine intervention effects. Note: The minimal time between Labs 1 and 3 will be 18 weeks, i.e., more than 3 months. 20% of interviews will contribute to fidelity checks.
次要结局
- Differential Change in Pre-Post Adiposity Assessed by Body Mass Index z-score (BMIz) (Child Outcome) Confirmatory: VIPP-SD-SingH more favorable trajectory than NeuroEducation; Exploratory: CARE-SD more favorable trajectory than NeuroEducation(Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session)
- Differential Change in Pre-Post Child Executive Functioning as Assessed via the MEFS. Confirmatory: VIPP-SD-SingH more favorable trajectory than NeuroEducation; Exploratory: CARE-SD more favorable trajectory than NeuroEducation(Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session)
研究者
Anne Rifkin-Graboi
Research Associate Professor
National University of Singapore