Home Play-based Intervention for Parents and Infants | NCT07716072

NCT07716072

Overview

NCT ID: NCT07716072
Lead Sponsor: Nanyang Technological UniversityOTHER
Official Title: Sociometric Play-based Remediation of Individual Neurodevelopmental Trajectories (SPRINT)
Brief Summary: 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Mar 2029Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 120Estimated
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Victoria LeongContact
victorialeong@ntu.edu.sg+65 6514 1052

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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