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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-65
SponsorNational University of Singapore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • VIPP-SD-SingH, "Video-Feedback Intervention to Promote Positive Parenting and Sensitive Discipline Adapted for the Singapore Context with a Health Component"

    Behavioral

    The VIPP-SD-SingH is an adaptation of the seven session home-visiting VIPP-SD program. During the first six VIPP-SD sessions the parent-child dyad will be asked to take part in certain activities together while being recorded. During sessions 2-7 the parent will watch the prior sessions's videos and receive frequent (e.g., 10-30 second) feedback ( e.g., focusing on children's perspectives, awareness of attachment and explorative child behavior, tips for sensitive discipline, and back-and-forth behavior). The VIPP-SD-SingH will include some adjustments for local language use and VIPP-SD compatible stimulation for reflections on tips and activities that allow greater generalization of the VIPP-SD principles to physical health contexts (e.g., waiting to eat a snack, using toys that encourage movement, or activities that may encourage relaxation).

  • CARE-SD, "Caregiver Awareness of Relationships through E-learning for Sensitivity and Discipline"

    Behavioral

    CARE-SD, Caregiver Awareness of Relationships through E-learning for Sensitivity and Discipline 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. As with the VIPP-SD-SingH, CARE-SD's design includes seven sessions with scenarios and comments for generalizability to physical activity, feeding, and relaxation. After watching each of the videos in sessions 2-7, parents will be asked to try out the activities they've viewed with their own child. Instructions and suggestions for materials will be provided as will be questions for reflection.

  • NeuroEducation for Parents

    Behavioral

    NeuroEducation for Parents was designed as a seven session online program for parents containing informational videos about young children's Brain Basics, Seven Senses, Learning and Memory, Emotion, Curiosity and Creativity, Thinking, and Friendships. Sensitive caregiving is not discussed explicitly. Each session will end with a short video quiz, complete with answers. Additional optional written material will be provided for parents who wish to learn more.

Treatment groups

624 Participants
are divided into 3 treatment groups
Group A: VIPP-SD-SingHExperimental treatment 1 intervention
Group B: CARE-SDOther 1 intervention
Group C: NeuroEducation for ParentsOther 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session
2

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

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.

Time frame
Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session

Secondary outcomes

1

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

Change in child adiposity will be evaluated using body mass index z-score (BMIz). Weight and height measurements will be obtained by trained study staff using standardized anthropometric procedures. These measurements will be used to calculate BMI as weight (kg) divided by height (m²), which will then be converted to an age- and sex-specific BMI z-score (BMIz) using established reference standards. Weight and height will not be analyzed as separate outcome measures.

Time frame
Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session
2

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

Child executive functioning (EF) will be assessed using the Minnesota Executive Function Scale (MEFS; Carlson \& Zelazo, 2014, 2021). The MEFS will be administered individually by trained staff. The MEFS consists of an adaptive virtual sorting task that provides a brief composite measure of EF. The assessment was designed for use across a wide range of ability levels, with task difficulty adjusted across seven levels based on the child's performance. MEFS Total Scores will be used to summarize EF, with higher scores indicating better EF.

Time frame
Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session

Other outcomes

1

Additional Exploratory Outcomes, Mediators, and Moderators

The following are a) exploratory outcomes evaluated as pre-post differential change, favoring the intervention(s) over the Neuroeducation control; and/or b) exploratory mediators/moderators: 1. Child Fitness: PreFit Tests (e.g., balance, 10m, long-jump) 2. Child Diet Quality: Reported frequencies of food groups 3. Parent Reported Child Psychosocial Fn and/or Executive Control: CBCL Internalizing, CBCL Attentional Problems, BRIEF-P 4. Parent Reported Feeding and Activity: Feeding Practices, PREPAQ 5. Parent Self-Reported Parenting: IM-P (mindfulness); PSDQ (parenting styles); Parenting Growth Mindset 6. Parent Self Reported Mental Health (DASS-21) and Executive Functioning (ADEXI) 7. Additional Measures of Observed Parenting 8. Cortisol from Hair 9. EEG Power/Asymmetry during resting and cognitive tasks 10. Emotional Memory 11. Genetic Moderation (e.g., SLC6A3 ePGS; ENVResp-ePGS) 12. Child Development/Brain Knowledge (expected to favor the NeuroEducation Control group)

Time frame
All laboratory pre-tests are prior to random assignment being revealed. Some measures are then also assessed whilst the treatments are ongoing, others 1-3 months after the last session, and others 6 or 12 months following the final treatment session.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Singapore

Lead sponsor

Nanyang Technological University

Collaborator

Institute for Human Development and Potential (IHDP), Singapore

Collaborator

National Institute of Education, Singapore

Collaborator

KK Women's and Children's Hospital

Collaborator