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

NCT07687524 | Recruiting

• 2 other identifiers: IRB: NUS-IRB-2025-92H23P1M0007
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Child Development; Child Behavioral Problems; Parent Child Relationship

Keywords

VIPP-SD; Sensitive caregiving; Executive function; BMI; Physical fitness; Externalizing problems; VIPP-SD-SingH; CARE-SD; NeuroEducation; Asian; Cortisol; Genetic; Dopamine; EEG; Theta; Frontal Alpha Asymmetry; Emotional memory bias; Preschool; Vicarious; Home visiting; Digital; Sensitive Discipline; Singapore

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Additional Exploratory Outcomes, Mediators, and Moderators

  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.

Study Arms (3)

VIPP-SD-SingH

EXPERIMENTAL

Participants assigned to this arm will receive the VIPP-SD-SingH program. Both adult and child participants will actively take part in at least some aspects of the VIPP-SD-SingH. Each VIPP-SD-SingH session is scheduled as close to 14 days after the prior home-visit as possible. Participants will not progress to the next VIPP-SD-SingH session if they have not completed the prior one. However, the maximum duration for the intervention will be 32 weeks.

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

CARE-SD

OTHER

Participants assigned to this arm will receive the CARE-SD program for proof of principle, implying whatever the outcome further tests are indispensable for translation to policy or practice. Results will further inform feasibility/acceptability and preliminarily efficacy information. Parents will be asked to watch online CARE-SD sessions and then involve children in activities. After session videos have been opened, participants can mark a session as complete. Then, the completed session's materials will remain accessible for 14 days. Marking a session "complete" also triggers the next session to open 14 days later. User metrics and additional self-reported involvement data (e.g., How much did you watch? Did you do the activities?) will be collected, but will not influence the first-level assessment of completion (for Intent to Treat analyses) or session progression. Participants will not progress without completing prior sessions, though the maximum duration will be 32 weeks.

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

NeuroEducation for Parents

OTHER

This arm will serve as an Active Control for both VIPP-SD-SingH and CARE-SD. It is not expected to notably impact sensitive caregiving though it may impact caregiver knowledge about child development. After a sessions' videos have been opened, participants will have access to a form where they can mark a session as complete. Once they do so, the completed session's materials will remain accessible for 14 days. Marking a session as "complete" also triggers the next session to open 14 days later. Although user metrics and additional self-reported involvement data (e.g., How much did you watch? Did you read the additional material?) will be collected, those will not influence the first-level assessment of completion (for Intent to Treat analyses) or session progression. People will not progress to the next NeuroEducation session if they have not completed the prior one. However, the maximum duration for the intervention will be 32 weeks.

Behavioral: NeuroEducation for Parents

Interventions

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).

Also known as: This was referred to as "O" or "Own" during earlier LOVING Development/Pilot research.

VIPP-SD-SingH

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.

Also known as: This was referred to as "V" or "Vicarious" in LOVING Developmental/Pilot research.

CARE-SD

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.

Also known as: This was referred to as "E" or "neuroEducation" in LOVING Developmental/Pilot research.

NeuroEducation for Parents

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: collaborator
• KK Women's and Children's Hospital: collaborator
• National University of Singapore: lead
• Nanyang Technological University: collaborator
• National Institute of Education, Singapore: collaborator

Study Sites (5)

Insitute of Human Development and Potential, Agency for Science and Technology Research (A*STAR)

Singapore, Singapore, 117609, Singapore

RECRUITING

National University of Singapore

Singapore, Singapore, 11907, Singapore

RECRUITING

KK Women and Children's Hospital

Singapore, Singapore, 229899, Singapore

RECRUITING

National Institute of Education, Nanyang Technological University

Singapore, Singapore, 637616, Singapore

RECRUITING

Nanyang Technological University

Singapore, Singapore, 639798, Singapore

RECRUITING

Related Publications (10)

• Pederson, D. R., Moran, G., & Bento, S. (2013). The Maternal Behavior Q-sort: Assessing Maternal Sensitivity and the Quality of Mother-Infant Interaction [Unpublished Manual]. University of Western Ontario.

  BACKGROUND

• Jiang, Y., Sun, S., Ji, X., Pang, A., Lim, S., Chin, W., Chong, M., Goodwill, A. M.,Khng, K., Chen, H., Setoh, P., Bakermans-Kranenburg, M. J., van IJzendoorn, M., & Rifkin-Graboi, A. (in preparation). Feasibility and acceptability of CARE-SD: A study of a digitally delivered parenting program in Singapore.

  BACKGROUND

• Egger, H. L., Angold, A., Small, B., & Copeland, W. (2019). The Preschool Age Psychiatric Assessment: A structured parent interview for assessing psychiatric symptoms and disorders in preschool children. In The Oxford handbook of infant, toddler, and preschool mental health assessment, 2nd ed. (pp. 227-243). Oxford University Press. https://doi.org/10.1093/oxfordhb/9780199837182.013.9

  BACKGROUND

• Carlson, S. M. (2021). Minnesota Executive Function Scale: Technical Report. Reflection Sciences, Inc. St. Paul, MN.

  BACKGROUND

• Carlson, S. M., & Zelazo, P. D. (2014). Minnesota Executive Function Scale: Test Manual. Reflection Sciences, Inc. St. Paul, MN.

  BACKGROUND

• van IJzendoorn MH, Schuengel C, Wang Q, Bakermans-Kranenburg MJ. Improving parenting, child attachment, and externalizing behaviors: Meta-analysis of the first 25 randomized controlled trials on the effects of Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline. Dev Psychopathol. 2023 Feb;35(1):241-256. doi: 10.1017/S0954579421001462. Epub 2022 Jan 17.

  PMID: 35034668 BACKGROUND

• Tarabulsy GM, Provost MA, Bordeleau S, Trudel-Fitzgerald C, Moran G, Pederson DR, Trabelsi M, Lemelin JP, Pierce T. Validation of a short version of the maternal behavior Q-set applied to a brief video record of mother-infant interaction. Infant Behav Dev. 2009 Jan;32(1):132-6. doi: 10.1016/j.infbeh.2008.09.006. Epub 2008 Nov 11.

  PMID: 19004503 BACKGROUND

• O'Farrelly C, Watt H, Babalis D, Bakermans-Kranenburg MJ, Barker B, Byford S, Ganguli P, Grimas E, Iles J, Mattock H, McGinley J, Phillips C, Ryan R, Scott S, Smith J, Stein A, Stevens E, van IJzendoorn MH, Warwick J, Ramchandani PG. A Brief Home-Based Parenting Intervention to Reduce Behavior Problems in Young Children: A Pragmatic Randomized Clinical Trial. JAMA Pediatr. 2021 Jun 1;175(6):567-576. doi: 10.1001/jamapediatrics.2020.6834.

  PMID: 33720329 BACKGROUND

• Nader PR, O'Brien M, Houts R, Bradley R, Belsky J, Crosnoe R, Friedman S, Mei Z, Susman EJ; National Institute of Child Health and Human Development Early Child Care Research Network. Identifying risk for obesity in early childhood. Pediatrics. 2006 Sep;118(3):e594-601. doi: 10.1542/peds.2005-2801.

  PMID: 16950951 BACKGROUND

• Brown T, Moore TH, Hooper L, Gao Y, Zayegh A, Ijaz S, Elwenspoek M, Foxen SC, Magee L, O'Malley C, Waters E, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2019 Jul 23;7(7):CD001871. doi: 10.1002/14651858.CD001871.pub4.

  PMID: 31332776 BACKGROUND

MeSH Terms

Interventions

Sensitivity and Specificity

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Statistics as Topic; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anne E Rifkin-Graboi, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy Yifan Jiang, PhD

CONTACT

80695639; jyifan@nus.edu.sg

Shamini Sanmugam, MA

CONTACT

80695639; shamini.sanmugam@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: The study will recruit participants in three sequential waves (target dyadic n = 210, 210, and 204) with block randomization occurring via a computer-generated random allocation sequence. There will be 12 randomization blocks, with each wave consisting of four randomization blocks. The first three blocks for each wave will consist of 60 dyads while the fourth block will consist of 30 dyads for Waves One and Two and 24 dyads for Wave Three. At the outset the allocation ratio will be 1:1:1 though this may be adjusted in later blocks following predetermined rules triggered by projected sample sizes that suggest necessary enrollment numbers will not be sufficient to maintain power for confirmatory analyses. Wave One participants will also be asked to take part in longer term light-touch follow-ups provided they complete their Lab1 visit by June 24, 2027 (for the 6 month follow-up) and Dec 23, 2027 (for the 12 month follow-up).

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: July 7, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): February 9, 2028
• Study Completion (Estimated): February 9, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-07

Locations

SG (5)