Home Play-based Intervention for Parents and Infants

Sponsor
Nanyang Technological University
Study ID
NCT07716072
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
9 Months - 15 Months
Healthy Volunteers
Not accepted

Interventions

  • SPRINT Intervention — BEHAVIORAL
    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.
  • Waitlist Protocol — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SPRINT Intervention Group
    Participants pseudorandomised to this arm following completion of the pre-intervention (T1) assessments will receive the 12-week SPRINT intervention and complete the post-intervention (T2) assessments.
  • Active Comparator: Waitlist Control Group
    Participants pseudorandomised to this arm following completion of the pre-intervention (T1) assessments will complete the 12-week waitlist control activities and the post-intervention (T2) assessments. Participants will also be offered the opportunity to receive the SPRINT intervention later.

Primary Outcome Measure

Parenting Behaviours [ Time Frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2) ]

Central Contacts

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