Home Play-based Intervention for Parents and Infants (SPRINT)

July 16, 2026 updated by: Victoria Leong, Nanyang Technological University

Sociometric Play-based Remediation of Individual Neurodevelopmental Trajectories (SPRINT)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: SPRINT Intervention
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.
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.
Other: Waitlist Protocol
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parenting Behaviours
Time Frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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
Time Frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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
Time Frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adult Wellbeing
Time Frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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.
Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
Adult Emotional Regulation
Time Frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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.
Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
Adult Executive Function
Time Frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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.
Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
Child Cognitive Development
Time Frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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.
Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanyang Technological University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KK Women's and Children's Hospital
Institute for Human Development and Potential (IHDP), Singapore
Agency for Science, Technology and Research (A*STAR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-2026-423
  • H24P2M0008 (Other Grant/Funding Number: A*STAR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Any data shared as part of this study will be fully anonymised to ensure that no individual participants can be identified, and will require specific consent from participants for their data to be shared beyond the study team for other research purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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