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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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. Automated reminders are provided to support adherence, and participant engagement and responses are monitored throughout the intervention. During the intervention period, home visits will also be conducted to provide study devices, programme orientation, training, and technical support. Brief parent-child play interaction recordings collected during these visits may also be used for analysis and to facilitate module content.
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.
NTU EMPOWER Centre
Singapore, Singapore
Parenting Behaviours
Parenting Behaviours will be assessed using three validated questionnaires: the Parenting Sense of Competence Scale Revised (PSOC-R) (Gilmore \& Cuskelly, 2024), the Emotional Availability Self-Report (EA-SR) (Biringen et al., 2002), and the Parental Reflective Functioning Questionnaire (PRFQ) (Luyten et al., 2017). Together, these instruments assess complementary dimensions of parenting, including parental competence, emotional attunement and the capacity to understand and reflect on their child's mental states. Analyses may consider each measure individually and/or as a composite measure, where appropriate. Higher scores indicate more positive parenting behaviours on the respective measures. Change from pre- to post-intervention will be assessed.
Time frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
Child Executive Function
This outcome measure is applicable only to participants allocated to the Executive Functioning (EF) Track in Module F. Children's EF will be assessed using age-appropriate tasks including the A-not-B task (Piaget \& Cook, 1954) and Snack/Object Delay Task. These tasks assess complementary components of EF, including working memory, inhibitory control and cognitive flexibility. Outcomes may be examined using individual task performance and/or a composite EF score, where appropriate. Higher scores indicate better EF on the respective tasks, where applicable. Change from pre- to post-intervention will be assessed.
Time frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
Child Socio-emotional Competencies
This outcome measure is applicable only to participants allocated to the Socio-Emotional (SE) Track in Module F. Children's SE will be assessed using the Ages \& Stages Questionnaire: Social-Emotional (ASQ-SE-2) (Squires et al., 2009), a validated caregiver-reported screening tool. The ASQ-SE-2 assesses complementary domains of SE development, including self-regulation, compliance, communication, adaptive functioning, autonomy, affect, and interaction with people. Higher scores indicate greater SE difficulties, with reductions in scores reflecting improvements in SE competence following the intervention. Change from pre- to post-intervention will be assessed.
Time frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
Adult Wellbeing
Parental wellbeing will be assessed using a set of validated self-report questionnaires: the Perceived Stress Scale (PSS) (Cohen, Kamarck, \& Mermelstein, 1983), the State-Trait Anxiety Inventory (STAI) (Spielberger, 1989), the Depression, Anxiety, and Stress Scales (DASS) (Lovibond \& Lovibond, 1995), the Satisfaction with Life Scale (SWLS) (Diener et al., 1985), the Affect Valuation Index (AVI) (Tsai \& Knutson, 2001), and the Scale of Positive and Negative Experience (SPANE) (Diener et al., 2010). Together, these instruments assess complementary dimensions of parental wellbeing, including perceived stress, anxiety, mood, life satisfaction, and states of positive and negative affect. Analyses may consider each measure individually and/or as a composite measure, where appropriate. Change from pre- to post-intervention will be assessed.
Time frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
Adult Emotional Regulation
Emotional regulation will be assessed using three validated self-report measures: the Southampton Mindfulness Questionnaire (SMQ) (Chadwick et al., 2008), the Five Facet Mindfulness Questionnaire (FFMQ) (Baer et al., 2006), and the Emotion Regulation Questionnaire (ERQ) (Gross \& John, 2003). Together, these instruments assess complementary aspects of emotional regulation, including mindfulness, reappraisal and suppression. Analysis may consider each measure individually and/or as a composite measure, where appropriate. Change from pre- to post-intervention will be assessed.
Time frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
Adult Executive Function
Adult EF will be assessed using validated self-report measure and a battery of standardized tasks. Everyday EF will be measured using the Behavior Rating Inventory of Executive Function, Second Edition-Adult (BRIEF-2A) (Roth et al., 2024). Task-based EF will be assessed using the Intra-Extra Dimensional Set Shift (IED), Inquisit Stop Signal Task (SST), Multitasking Test (MTT), and Spatial Working Memory (SWM) task from CANTAB (Langley, Sahakian, \& Robbins, 2023). Together, these measures assess complementary aspects of EF. Analyses may consider each measure individually and/or as composite measures, where appropriate. Change from pre- to post-intervention will be assessed.
Time frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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Child Cognitive Development
Children's cognitive development will be assessed using the cognitive subscale of the Bayley Scales of Infant and Toddler Development (Bayley) (Bayley \& Aylward, 2019), a standardized administration measuring early cognitive functioning. The Bayley Cognitive Scale assesses key domains including attention, memory, problem-solving, and early concept formation. Higher scores indicate more advanced cognitive development. Change from pre- to post-intervention will be assessed.
Time frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)