Home Play-based Intervention for Parents and Infants

Официальное название

Sociometric Play-based Remediation of Individual Neurodevelopmental Trajectories (SPRINT)

Обзор

The goal of this clinical trial is to learn whether a 12-week home-based intervention (Sociometric Play-based Remediation of Individual Neurodevelopmental Trajectories (SPRINT)) helps support parenting and the development of infants aged 7 - 15 months (at the time they join the study) who were born preterm and/or have a higher family risk of developmental conditions, such as autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), and/or global developmental delay (GDD). The main questions it aims to answer are: * Does taking part in the SPRINT intervention help parents develop parenting skills? * Does taking part in the SPRINT intervention improve infant's thinking skills and/or socio-emotional development? Researchers will compare families who receive the SPRINT intervention with families in a waitlist control group to see whether the intervention leads to greater improvements in parents and their children. Participants will: * Complete questionnaires and in-person assessments, before and after the 12-week period. * Be assigned to either the SPRINT intervention or a waitlist control group and complete the assigned activities for 12 weeks. * Use the SPRINT app, which provides information, guidance and activities for either the SPRINT intervention or waitlist control group.

Подробное описание

This study evaluates the efficacy of SPRINT, a 12-week, home-based, parent-delivered intervention developed to promote parenting and early development in infants at increased risk of neurodevelopmental difficulties. Existing early interventions have demonstrated benefits for parent and child outcomes but often require delivery by trained practitioners and substantial time commitments, which may limit accessibility and scalability for families requiring timely support. To address this limitation, SPRINT was developed as an age-appropriate, home-deliverable intervention that can be implemented during infancy to support both parent and child.

This study is a two-arm, parallel, waitlist-controlled interventional trial involving approximately 120 parent-infant dyads. All participants will complete online questionnaires and attend laboratory visits at both pre-intervention (T1) and post-intervention (T2). During these visits, participants will complete tasks assessing executive function (EF), emotional processing, socio-emotional (SE) functioning, cognitive development, and parent-child interactions. Physiological and neurophysiological measures, including electroencephalography (EEG) and electrocardiography (ECG), may be collected during the study. Audiovisual recordings will also be obtained to characterise parent-infant interactions, facial expressions, posture and vocal behaviour.

Following completion of the questionnaires and visits at T1, participants will be pseudorandomised to either the SPRINT intervention or waitlist control group (N = 60 per group, sufficient to detect a medium effect size with .80 power, alpha = .05, including 10% attrition), with allocation balanced according to variables such as child age, sex, risk category, developmental needs (e.g., from ASQ-SE, IBQ-R and lab-based EF tasks score), and/or previous treatments received to minimise imbalance between groups. Participants in the SPRINT intervention group will complete the 12-week SPRINT programme, while those in the waitlist control group will complete the brief app-based activities designed to maintain engagement without providing structured developmental training. Within the SPRINT intervention group, participants will be further allocated to either an EF or SE track based on developmental needs identified.

Primary analyses will compare changes over time between the SPRINT intervention and waitlist control groups. Relevant characteristics may be included as covariates where appropriate to account for individual differences and explore variability in treatment responses.

Вмешательства

• Поведенческое SPRINT Intervention
  The SPRINT intervention is a 12-week, home-based, parent-delivered programme designed to promote responsive caregiving, parental and child executive function, emotion regulation, and child's socio-emotional development. The intervention is delivered via the SPRINT app and comprises six concurrent modules: (A) Awareness, (B) Bond, (C) Cognition, (D) Decode, (E) Emotions, and (F) Fun. On average, participants are expected to engage with programme activities for approximately 25 minutes per day. Au
• Другое Waitlist Protocol
  Participants will complete brief app-based activities during the 12-week waitlist period using the study devices provided. These activities are designed to maintain participant engagement without providing structured training targeting cognitive or socio-emotional skills, and involve simple visual or sensory interactions (e.g., tapping tasks or basic touch-based activities). The app will also send reminders, and activity completion will be logged.

Первичные конечные точки

• Parenting Behaviours [Срок оценки: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)]
• Child Executive Function [Срок оценки: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)]
• Child Socio-emotional Competencies [Срок оценки: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)]

Вторичные конечные точки (4)

• Adult Wellbeing [Срок оценки: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)]
• Adult Emotional Regulation [Срок оценки: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)]
• Adult Executive Function [Срок оценки: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)]
• Child Cognitive Development [Срок оценки: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)]

Критерии участия

Критерии включения

All participants must satisfy the following criteria:

• Parent(s) must have access to the internet via a computer, laptop or phone.
• Parent (s) with adequate English comprehension skills to participate in the study tasks and provide consent

Participants will be included if they meet either of the following criteria:

\- Parent(s) with infants who are identified as having increased familial risk of ASD, ADHD, GDD, related neurodevelopmental disorders or premature birth outcomes. Prematurity is defined as being born before 37 weeks.

Критерии исключения

Participants will be excluded if they meet the following criteria:

• Parent(s) and infants with brain injury, severe motor or sensory impairments (e.g., visual or hearing) that would render them unable to participate in the tasks
• Parent(s) diagnosed to have impaired intellectual functioning or mental capacity.
• Infants with an identified genetic, metabolic, syndromic, or progressive neurological disorder (e.g., epilepsy, Down or Rett Syndrome, Tuberous Sclerosis, Neurofibromatosis, Fragile X Syndrome), including vascular risk factors
• Parent (s) with current or pre-existing diagnosed psychological conditions.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• NTU EMPOWER Centre — Singapore

Публикации

• Tsai, J. L., & Knutson, B. (2001). Affect Valuation Index (AVI). Unpublished measure, Stanford University.
• Squires, J., Bricker, D., & Twombly, E. (2009). Ages & Stages Questionnaires: Social-Emotional (2nd ed.). Paul H. Brookes Publishing.
• Spielberger, C. D. (1989). State-Trait Anxiety Inventory: Bibliography (2nd ed.). Consulting Psychologists Press.
• Rothbart, M. K. (1981). Measurement of temperament in infancy. Child Development, 52, 569-578.
• Piaget, J., & Cook, M. T. (1954). The construction of reality in the child. Basic Books.
• Luyten P, Mayes LC, Nijssens L, Fonagy P. The parental reflective functioning questionnaire: Development and preliminary validation. PLoS One. 2017 May 4;12(5):e0176218. doi: 10.1371/journal.pone.0176218. eCollection 2017. PMID 28472162
• Lovibond, P. F., & Lovibond, S. H. (1995). Manual for the Depression Anxiety Stress Scales (2nd ed.). Psychology Foundation.
• Langley, C., Sahakian, B., & Robbins, T. (2023). Cambridge Neuropsychological Test Automated Battery (CANTAB). In G. J. Boyle, Y. Stern, D. J. Stein, B. J. Sahakian, C. J. Golden, T. M. Lee, & S. A. Chen (Eds.), Cambridge handbook of psychology, health and medicine (Vol. 0, pp. 435-468). SAGE Publications.

Идентификаторы

NCT: NCT07716072 · IRB-2026-423 · H24P2M0008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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