Early Movers Program for Child Development

Overseen By Morgan Potter, MSc.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Non-English speakers, Full-time childcare, Preterm birth, Underweight, Health complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help parents enhance their baby's development by promoting healthy movement habits. It focuses on educating parents about the Canadian 24-Hour Movement Guidelines for infants, using resources like a digital app and weekly tips. The trial, called the Early Movers Program, builds on a successful Australian program and will evaluate how well this approach works for first-time parents. Parents with infants around two months old who are not using full-time childcare might be suitable for this study. As an unphased trial, it offers parents the chance to actively contribute to research that could improve early childhood development strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Early Movers intervention is safe for child development?

Research has shown that the Early Movers program includes activities that are safe and beneficial for children. For instance, a similar program called SAFE improved children's movement and senses while enhancing their home environment. As a result, children not only improve physically but also enjoy a more stimulating place to grow.

Another study on a similar program found that it enhanced children's thinking, speaking, and sensory skills. This means children become better at thinking, talking, and using their senses. The program also enriches the home environment, supporting overall development.

No specific negative effects have been reported in these types of early intervention programs, which reassures parents considering the Early Movers program for their children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Early Movers Program for child development because it takes a fresh approach by combining educational resources with digital support. Unlike traditional methods that might rely solely on in-person interventions or printed materials, this program offers a digital app and weekly text messages to provide ongoing, accessible support and practical tips. This blend of digital and physical resources aims to make it easier for parents to engage with and support their child's development in real-time, potentially leading to improved outcomes.

What evidence suggests that the Early Movers intervention could be effective for child development?

Research has shown that programs focusing on early childhood development can positively affect children's cognitive and motor skills. Combined results from several studies indicate that these programs can improve cognitive skills in children under 3 years old. In this trial, the Early Movers program, which participants may receive, uses these findings to help parents learn and apply the 24-Hour Movement Guidelines for young children. This program provides educational materials, a digital app, and helpful text messages to support parents. The aim is to improve movement habits in young children, potentially enhancing their overall development. ^{3 6 7 8 9}

Who Is on the Research Team?

Lesley Pritchard, PhD

Principal Investigator

University of Alberta

Guy Faulkner, PhD

Principal Investigator

University of British Columbia

Valerie Carson, PhD

Principal Investigator

University of Alberta

Sam Liu, PhD

Principal Investigator

University of Victoria

Kylie Hesketh, PhD

Principal Investigator

Deakin University

Are You a Good Fit for This Trial?

This trial is for first-time parents with infants aged between 2 months and almost 3 months. It aims to help these parents improve their child's development by following Canadian movement guidelines.

Inclusion Criteria

I am a first-time parent with an infant aged 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment and Baseline

Recruitment of participants and baseline data collection including questionnaires on movement behaviour and development

6 months

Multiple visits for recruitment and baseline data collection

Intervention

Participants receive educational resources, access to a digital app, and weekly supportive text messages

4 months

Ongoing digital engagement

Follow-up

Participants are monitored for feasibility and acceptability of the intervention, including interviews and questionnaires

4 months

2-month and 4-month follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Early Movers

Trial Overview

The 'Early Movers' intervention, adapted from an Australian program called INFANT, is being tested to see if it helps increase adherence to the Canadian 24-Hour Movement Guidelines in infancy.

How Is the Trial Designed?

Group I: Early Movers Intervention Experimental Treatment 1 Intervention

Participants will receive an educational resource (i.e., hard copy hand-out), access to a digital app with an online toolkit and weekly text messages that includes tips and supportive messaging.

Group II: Control Active Control 1 Intervention

Participant will receive standard care.

Early Movers is already approved in Canada for the following indications:

Approved in Canada as Early Movers for:

• Promoting adherence to the Canadian 24-Hour Movement Guidelines in infancy

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Published Research Related to This Trial

The Explorer Baby early intervention program showed promising improvements in cognitive and explorative language skills for preterm infants, suggesting it may be beneficial for their holistic development, although these results were not statistically significant compared to the control group.

Both the Explorer Baby program and the active control neurodevelopmental therapy (NDT) were found to be safe, as they did not negatively impact the overall stress levels of the mothers involved in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early developmental support for preterm infants based on exploratory behaviors: A parallel randomized controlled study. Altunalan, T., Sarı, Z., Doğan, TD., et al.[2023]

Research on very low birth weight infants has shifted from just focusing on survival rates and immediate health issues to examining long-term neurodevelopmental outcomes and the impact of neonatal interventions.

Despite advances in care, very low birth weight survivors still face a higher risk of neurodevelopmental impairments and other health challenges, highlighting the need for effective follow-up assessments and interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How should we report early childhood outcomes of very low birth weight infants? Vohr, BR.[2022]

The Infant Behavioral Assessment and Intervention Program significantly improved motor development in very preterm infants, with a notable effect size of 0.4 SD, as assessed over several years in a study of 176 infants.

Infants with bronchopulmonary dysplasia (BPD) benefited even more, showing significant improvements in both cognitive (0.7 SD) and motor (0.9 SD) development, highlighting the program's effectiveness for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early intervention leads to long-term developmental improvements in very preterm infants, especially infants with bronchopulmonary dysplasia. Van Hus, J., Jeukens-Visser, M., Koldewijn, K., et al.[2022]

Early intervention programs can positively impact the development of children at risk for delays, showing moderate effectiveness in enhancing their developmental skills.

Despite the promising results, many studies on early interventions have significant methodological weaknesses, highlighting the need for more rigorous randomized clinical trials to identify the most effective programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of early intervention for children with developmental disabilities. Majnemer, A.[2019]

The study involved 130 moderate to late preterm infants, comparing a novel hospital-home intervention (HHI) with traditional interventions, showing that HHI focuses on personalized motor development strategies and parental training.

Preliminary results suggest that the HHI, which includes sensory and motor stimulation along with mobile app support, may significantly enhance motor development in premature infants compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor development in premature infants: Study protocol for an interdisciplinary hospital-home intervention. Sandoval-Cuellar, C., Castellanos-Garrido, AL., Ospina Romero, AM., et al.[2023]

The program is designed to support the developmental enrichment of infants up to 12 months old who experience generalized developmental delays associated with mental retardation.

It is a parent-oriented approach, where parents implement the program under the guidance of a physiotherapist, ensuring that the intervention is accessible and tailored to the needs of the family.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An infant enrichment programme. Shepherd, RB.[2014]

The Infant Health and Development Program, involving 985 low-birth-weight premature infants, demonstrated that a comprehensive early intervention significantly improved IQ scores at 36 months compared to standard pediatric follow-up, with mean differences of 13.2 for heavier infants and 6.6 for lighter infants.

The intervention also resulted in fewer reported behavior problems among mothers of infants in the intervention group, although there was a slight increase in reported minor illnesses for the lighter-birth-weight group, with no impact on serious health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the outcomes of low-birth-weight, premature infants. A multisite, randomized trial. The Infant Health and Development Program. [2019]

In a longitudinal study of pediatric physical therapy for infants at risk of neurodevelopmental disorders, the focus on specific educational actions and communication with caregivers increased significantly over time, suggesting a shift towards greater family involvement in therapy sessions.

Despite these changes, the core neuromotor actions in therapy remained stable, indicating that the fundamental approach to addressing motor skills in infants has not changed significantly between the two study periods (2003-2005 and 2008-2014).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in the Content of Pediatric Physical Therapy for Infants: A Quantitative, Observational Study. Hielkema, T., Toonen, RF., Hooijsma, SJ., et al.[2019]

In-hospital growth velocity in extremely low birth weight (ELBW) infants is a strong predictor of neurodevelopmental outcomes, such as the incidence of cerebral palsy and developmental delays, at 18 to 22 months' corrected age, with higher growth rates linked to better outcomes.

The study, which evaluated 495 out of 600 discharged ELBW infants, found that increased weight gain and head circumference growth during hospitalization were significantly associated with lower rates of neurodevelopmental impairment, even after controlling for various demographic and clinical factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Ehrenkranz, RA., Dusick, AM., Vohr, BR., et al.[2007]

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