Attention-Deficit/Hyperactivity Disorder (ADHD)SPRINTNCT07716072
Home Play-based Intervention for Parents and Infants
A study testing SPRINT Intervention and Waitlist Protocol in people with Attention-Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder, run by Nanyang Technological University at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 15 months
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder, Premature Birth
- What is being tested?
- SPRINT Intervention and Waitlist Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2026to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
NTU EMPOWER Centre
Singapore, 308232
Victoria Leong, +65 6514 1052, victorialeong@ntu.edu.sg
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder, Premature Birth, Global Developmental Delay
- Being tested
- SPRINT Intervention, Waitlist Protocol
- Keywords
- Intervention, At-Risk Cohort, Play-based, Home, Social Emotional, Executive Function, Emotional Regulation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder, Premature Birth, Learning Disabilities, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPRINT InterventionBehavioural
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 ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Waitlist Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
Secondary outcomes (4)
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.
Measured: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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.
Measured: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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.
Measured: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
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.
Measured: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research (A*STAR), KK Women's and Children's Hospital, Institute for Human Development and Potential (IHDP), Singapore
- Responsible party
- Principal investigator, Victoria Leong, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716072
- Sponsor's protocol ID
- IRB-2026-423
- Other IDs
- H24P2M0008
- Acronym
- SPRINT
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
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.
PubMed 28472162Lovibond, 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.
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.
PubMed 12916575Gilmore 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.
PubMed 37812533Diener, 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.
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.
PubMed 16367493Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Chadwick 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.
PubMed 18573227Biringen 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.
PubMed 11707915
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sociometric Play-based Remediation of Individual Neurodevelopmental Trajectories (SPRINT)
- ClinicalTrials.gov ID
- NCT07716072
- Acronym / sponsor ID
- SPRINT / IRB-2026-423
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research (A*STAR), KK Women's and Children's Hospital, Institute for Human Development and Potential (IHDP), Singapore
- Study start
- Jul 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SPRINT Intervention Group | Experimental | Behavioral: SPRINT InterventionParticipants 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. |
| Waitlist Control Group | Active comparator | Other: Waitlist ProtocolParticipants 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. |
Who may qualify
- Ages
- 9 to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPRINT InterventionThe 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. | Behavioural | SPRINT Intervention Group |
| Waitlist ProtocolParticipants 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. | Other | Waitlist Control Group |
Primary outcome
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.
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.
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.
4 secondary outcomes
Adult Wellbeing
Time frame: 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)
Adult Executive Function
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- BackgroundTsai, J. L., & Knutson, B. (2001). Affect Valuation Index (AVI). Unpublished measure, Stanford University.
- BackgroundSquires, J., Bricker, D., & Twombly, E. (2009). Ages & Stages Questionnaires: Social-Emotional (2nd ed.). Paul H. Brookes Publishing.
- BackgroundSpielberger, C. D. (1989). State-Trait Anxiety Inventory: Bibliography (2nd ed.). Consulting Psychologists Press.
- BackgroundRothbart, M. K. (1981). Measurement of temperament in infancy. Child Development, 52, 569-578.
- BackgroundPiaget, J., & Cook, M. T. (1954). The construction of reality in the child. Basic Books.
- Background: PubMed 28472162Luyten 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.
- BackgroundLovibond, P. F., & Lovibond, S. H. (1995). Manual for the Depression Anxiety Stress Scales (2nd ed.). Psychology Foundation.
- BackgroundLangley, 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: PubMed 12916575Gross 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.
- Background: PubMed 37812533Gilmore 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.
- BackgroundDiener, 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: PubMed 16367493Diener 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPRINT Intervention and Waitlist Protocol in people with Attention-Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder, run by Nanyang Technological University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Leong (+65 6514 1052, victorialeong@ntu.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Behaviours (time frame: Pre-Intervention (T1) and, immediately after completion of the 12-week intervention/control period, Post-Intervention (T2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07716072, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.