Home Play-based Intervention for Parents and Infants

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-15
SponsorNanyang Technological University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: SPRINT Intervention GroupExperimental treatment 1 intervention
Group B: Waitlist Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
2

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.

Time frame
Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
3

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.

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

Secondary outcomes

1

Adult Wellbeing

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.

Time frame
Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
2

Adult Emotional Regulation

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.

Time frame
Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
3

Adult Executive Function

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.

Time frame
Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
4

Child Cognitive Development

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.

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

Other outcomes

Sponsors and contacts

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Nanyang Technological University

Lead sponsor

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

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