Home Play-based Intervention for Parents and Infants (SPRINT)
16 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
120
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Victoria Leong
- Numero di telefono: +65 6514 1052
- Email: victorialeong@ntu.edu.sg
Luoghi di studio
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Singapore, Singapore, 308232
- NTU EMPOWER Centre
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Contatto:
- Victoria Leong
- Numero di telefono: +65 6514 1052
- Email: victorialeong@ntu.edu.sg
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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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.
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Comparatore attivo: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Parenting Behaviours
Lasso di tempo: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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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.
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Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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Child Executive Function
Lasso di tempo: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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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.
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Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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Child Socio-emotional Competencies
Lasso di tempo: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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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.
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Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Adult Wellbeing
Lasso di tempo: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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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.
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Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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Adult Emotional Regulation
Lasso di tempo: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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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.
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Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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Adult Executive Function
Lasso di tempo: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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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.
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Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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Child Cognitive Development
Lasso di tempo: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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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.
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Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Tsai, J. L., & Knutson, B. (2001). Affect Valuation Index (AVI). Unpublished measure, Stanford University.
- Squires, J., Bricker, D., & Twombly, E. (2009). Ages & Stages Questionnaires: Social-Emotional (2nd ed.). Paul H. Brookes Publishing.
- Spielberger, C. D. (1989). State-Trait Anxiety Inventory: Bibliography (2nd ed.). Consulting Psychologists Press.
- Rothbart, M. K. (1981). Measurement of temperament in infancy. Child Development, 52, 569-578.
- Piaget, J., & Cook, M. T. (1954). The construction of reality in the child. Basic Books.
- Lovibond, P. F., & Lovibond, S. H. (1995). Manual for the Depression Anxiety Stress Scales (2nd ed.). Psychology Foundation.
- 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.
- 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.
- 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.
- 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.
- Bayley, N., & Aylward, G. P. (2019). Bayley scales of infant and toddler development (4th ed.). Pearson.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 luglio 2026
Completamento primario (Stimato)
1 marzo 2029
Completamento dello studio (Stimato)
1 marzo 2030
Date di iscrizione allo studio
Primo inviato
13 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
16 luglio 2026
Primo Inserito (Effettivo)
21 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Disordini mentali
- Malattie urogenitali femminili e complicanze della gravidanza
- Travaglio ostetrico, prematuro
- Complicanze ostetriche del lavoro
- Complicazioni della gravidanza
- Manifestazioni neurocomportamentali
- Disturbi del neurosviluppo
- Disturbi dello sviluppo infantile, pervasivi
- Disturbi da deficit di attenzione e comportamento dirompente
- Disturbi della comunicazione
- Condizioni patologiche, segni e sintomi
- Comportamento
- Segni e sintomi
- Comportamento sociale
- Autocontrollo
- Disturbo dello spettro autistico
- Nascita prematura
- Disturbo da deficit di attenzione con iperattività
- Difficoltà di apprendimento
- Regolazione emotiva
Altri numeri di identificazione dello studio
- IRB-2026-423
- H24P2M0008 (Altro numero di sovvenzione/finanziamento: A*STAR)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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