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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое VIPP-SD-SingH, "Video-Feedback Intervention to Promote Positive Parenting and Sensitive Discipline Adapted for the Singapore Context with a Health Component"
  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 b
• Поведенческое CARE-SD, "Caregiver Awareness of Relationships through E-learning for Sensitivity and Discipline"
  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.
• Поведенческое NeuroEducation for Parents
  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.

Первичные конечные точки

• 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 [Срок оценки: 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 [Срок оценки: Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session]

Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: Prior to revealing the Treatment Arm until One to Three Months Post Last Intervention Session]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Сингапур · 5 центров

• Insitute of Human Development and Potential, Agency for Science and Technology Research (A — Singapore
• National University of Singapore — Singapore
• KK Women and Children's Hospital — Singapore
• National Institute of Education, Nanyang Technological University — Singapore
• Nanyang Technological University — Singapore

Публикации

• 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.
• 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.
• 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
• Carlson, S. M. (2021). Minnesota Executive Function Scale: Technical Report. Reflection Sciences, Inc. St. Paul, MN.
• Carlson, S. M., & Zelazo, P. D. (2014). Minnesota Executive Function Scale: Test Manual. Reflection Sciences, Inc. St. Paul, MN.
• 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
• 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
• 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):567-57 PMID 33720329

Идентификаторы

NCT: NCT07687524 · IRB: NUS-IRB-2025-92 · H23P1M0007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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