LOVING (Learning About Our Behavior is Valuable for Increasing Nurturing Relationships and Healthy Growth) RCT

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.

Additional discovery analyses will compare VIPP-SD-SingH versus NeuroEducation Control and CARE-SD versus NeuroEducation Control on other outcomes, as well as mediating and moderating processes, including genetic moderators.

Six-hundred-twenty four parent-young-child pairs from median-income and below households will be recruited and randomly assigned to one of three study groups. Sample size was determined via G-power 3.1 in the following way. First, the minimal sample size needed for the primary confirmatory (VIPP-SD-SingH versus NeuroEducation) outcomes assessed with a repeated measures design and interaction term was calculated. With regards to parental sensitivity, an effect size of f = 0.18 was assumed based on prior meta-analytic data and f = 0.12 was chosen for ODD+CD symptoms in keeping with that reported with similar interview data within HSHS . Using an alpha of .05, correlations between pretest and posttest assessments of r = .30, and power .95, the required dyadic sample size is 72 per arm for parental sensitivity and 159 per arm for oppositional defiant and conduct problems. Assuming a 15 percent drop-out rate the necessary dyadic numbers become 83 and 183.

In addition, G-power 3.1 was also used to calculate the minimal sample size needed for the secondary confirmatory (VIPP-SD-SingH versus NeuroEducation) analyses. Given the comparatively limited literature base, rather than relying on past published effect sizes, f = 0.10 was chosen as a reasonable estimate for behavioral interventions. Using an alpha of .025 (i.e., corrected for the two secondary outcomes [i.e., MEFS performance & BMIz]), correlations between pretest and posttest assessments of r = .30, and power .80, the required dyadic sample size is 168 per arm, which becomes 194 after adjusting for a 15% drop-out rate.

Considering the parallel exploratory analyses requiring the additional CARE-SD arm, the total sample size should be minimally 249 (parental sensitivity), 548 (ODD and CD symptoms), and 582 (adiposity and executive functioning ). As such, even with the addition of covariates, the anticipated sample size of 624 dyads should be sufficient to detect primary and secondary confirmatory outcomes.

Participating families will complete research visits that include questionnaires, structured observations of parent-child interaction, hair samples for hormonal analyses, buccal cell swabs for genetic moderation, electrophysiology and assessments of children's development including executive functioning, emotional memory, and physical fitness. These assessments will allow for explorations of whether the interventions improve parenting sensitivity and child outcomes and whether changes in caregiving are associated with improvements in children's emotional, behavioral, cognitive, and physical outcomes.

Upon trial completion an exploratory cost effectiveness analysis of the VIPP-SD-SingH program versus NeuroEducation will be conducted. Findings from the LOVING trial will contribute to the limited evidence base on parenting interventions in Asian populations and will help inform the development of alternative approaches to support families and promote healthy child development in Singapore and similar contexts.

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.