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NCT07716072
Home Play-based Intervention for Parents and Infants
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder, Premature Birth, Global Developmental Delay
Sex: All
Ages: 9 Months – 15 Months
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Nanyang Technological University
Location: NTU EMPOWER Centre Singapore
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.
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.
Source: ClinicalTrials.gov (NCT07716072). StuddyBuddy aggregates publicly available trial information.