Home Play-based Intervention for Parents and Infants (SPRINT)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Victoria Leong
- 電話番号：+65 6514 1052
- メール：victorialeong@ntu.edu.sg
研究場所
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Singapore、シンガポール、308232
- NTU EMPOWER Centre
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コンタクト：
- Victoria Leong
- 電話番号：+65 6514 1052
- メール：victorialeong@ntu.edu.sg
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Parenting Behaviours
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adult Wellbeing
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB-2026-423
- H24P2M0008 (その他の助成金/資金番号：A*STAR)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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SPRINT Interventionの臨床試験
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SPR Therapeutics, Inc.完了
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Saint Peters University HospitalUniversity Orthopaedic Associates - Division of OrthoNJ募集
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