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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Our Early Movers longitudinal study found that adherence to the Canadian 24-Hour Movement Guidelines in infancy is low across demographic groups, impacting overall development. Early Movers is a parent-focused intervention designed to increase dissemination and activation of the 24-Hour Movement Behaviour Guidelines for the Early Years. It adapts an established Australian intervention called INFANT. An important first step is conducting a pilot study.

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 data supports the effectiveness of the Early Movers treatment for child development?

The Infant Health and Development Program study showed that a comprehensive early intervention, which included educational support for child development, led to higher IQ scores and fewer behavior problems in low-birth-weight, premature infants. This suggests that early interventions like the Early Movers treatment can positively impact child development. ^{1 2 3 4 5}

How is the Early Movers treatment different from other treatments for child development?

The Early Movers Program is unique because it adapts the INFANT intervention, focusing on early intervention to enhance developmental competence and prevent delays in children, particularly those who are environmentally or biologically vulnerable. Unlike other treatments, it emphasizes a holistic approach to child development, potentially offering moderate positive effects, although more research is needed to confirm its efficacy. ^{3 6 7 8 9}

Research Team

Guy Faulkner, PhD

Principal Investigator

University of British Columbia

Sam Liu, PhD

Principal Investigator

University of Victoria

Valerie Carson, PhD

Principal Investigator

University of Alberta

Kylie Hesketh, PhD

Principal Investigator

Deakin University

Lesley Pritchard, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. [2007]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. Singapore pubmed.ncbi.nlm.nih.gov

Motor development in premature infants: Study protocol for an interdisciplinary hospital-home intervention. [2023]

4. United States 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]

5. England pubmed.ncbi.nlm.nih.gov

Changes in the Content of Pediatric Physical Therapy for Infants: A Quantitative, Observational Study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Norway pubmed.ncbi.nlm.nih.gov

Early intervention leads to long-term developmental improvements in very preterm infants, especially infants with bronchopulmonary dysplasia. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Early developmental support for preterm infants based on exploratory behaviors: A parallel randomized controlled study. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

An infant enrichment programme. [2014]