Home Play-based Intervention for Parents and Infants

NCT07716072 | Not Yet Recruiting DMC

• 2 other identifiers: IRB-2026-423H24P2M0008
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD); Autism Spectrum Disorder; Premature Birth; Global Developmental Delay

Keywords

Intervention; At-Risk Cohort; Play-based; Home; Social Emotional; Executive Function; Emotional Regulation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)

Secondary Outcomes (4)

• Adult Wellbeing

  Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)

• Adult Emotional Regulation

  Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)

• Adult Executive Function

  Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)

• Child Cognitive Development

  Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)

Study Arms (2)

SPRINT Intervention Group

EXPERIMENTAL

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.

Behavioral: SPRINT Intervention

Waitlist Control Group

ACTIVE COMPARATOR

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.

Other: Waitlist Protocol

Interventions

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.

Waitlist Control Group

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.

SPRINT Intervention Group

Eligibility Criteria

• Age: 9 Months - 15 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanyang Technological University: lead
• Agency for Science, Technology and Research (A*STAR): collaborator
• KK Women's and Children's Hospital: collaborator
• Institute for Human Development and Potential (IHDP), Singapore: collaborator

Study Sites (1)

NTU EMPOWER Centre

Singapore, 308232, Singapore

Location

Related Publications (17)

• Tsai, J. L., & Knutson, B. (2001). Affect Valuation Index (AVI). Unpublished measure, Stanford University.

  BACKGROUND

• Squires, J., Bricker, D., & Twombly, E. (2009). Ages & Stages Questionnaires: Social-Emotional (2nd ed.). Paul H. Brookes Publishing.

  BACKGROUND

• Spielberger, C. D. (1989). State-Trait Anxiety Inventory: Bibliography (2nd ed.). Consulting Psychologists Press.

  BACKGROUND

• Rothbart, M. K. (1981). Measurement of temperament in infancy. Child Development, 52, 569-578.

  BACKGROUND

• Piaget, J., & Cook, M. T. (1954). The construction of reality in the child. Basic Books.

  BACKGROUND

• 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 BACKGROUND

• Lovibond, P. F., & Lovibond, S. H. (1995). Manual for the Depression Anxiety Stress Scales (2nd ed.). Psychology Foundation.

  BACKGROUND

• 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.

  BACKGROUND

• Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.

  PMID: 12916575 BACKGROUND

• Gilmore L, Cuskelly M. The Parenting Sense of Competence scale: Updating a classic. Child Care Health Dev. 2024 Jan;50(1):e13173. doi: 10.1111/cch.13173. Epub 2023 Oct 9.

  PMID: 37812533 BACKGROUND

• Diener, E., Wirtz, D., Tov, W., Kim-Prieto, C., Choi, D., Oishi, S., & Biswas-Diener, R. (2010). New well-being measures: Short scales to assess flourishing and positive and negative feelings. Social Indicators Research, 97(2), 143-156.

  BACKGROUND

• Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

  PMID: 16367493 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Chadwick P, Hember M, Symes J, Peters E, Kuipers E, Dagnan D. Responding mindfully to unpleasant thoughts and images: reliability and validity of the Southampton mindfulness questionnaire (SMQ). Br J Clin Psychol. 2008 Nov;47(Pt 4):451-5. doi: 10.1348/014466508X314891. Epub 2008 Jun 20.

  PMID: 18573227 BACKGROUND

• Biringen Z, Robinson JL, Emde RN. Appendix A: the emotional availability scales (2nd ed.; an abridged infancy/Early Childhood version). Attach Hum Dev. 2000 Sep;2(2):251-70. doi: 10.1080/14616730050085617. No abstract available.

  PMID: 11707915 BACKGROUND

• Bayley, N., & Aylward, G. P. (2019). Bayley scales of infant and toddler development (4th ed.). Pearson.

  BACKGROUND

• Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

  PMID: 16443717 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Premature Birth; Learning Disabilities; Emotional Regulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior; Behavior

Central Study Contacts

Victoria Leong

CONTACT

+65 6514 1052; victorialeong@ntu.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This study will be conducted as an open-label trial with no masking. Participants will be aware of their group assignment (SPRINT intervention or waitlist control), as the nature of the intervention does not allow for blinding. Investigators and personnel delivering the intervention will also be aware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study will use a parallel assignment, waitlist-controlled interventional design. Participants will be pseudorandomised to either (1) the SPRINT intervention or (2) the waitlist control group, with allocation balanced according to 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. Intervention efficacy will be evaluated by comparing outcomes between the two groups using the assessments collected at T1 and post-intervention (T2). Participants initially assigned to the waitlist control group will be offered the opportunity to receive the same intervention later.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 21, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

SG (1)