Preschool and Me for Developmental Delay

(PreM Trial)

Overseen By Reshma Shah, MD, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

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: 16

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Preschool and Me, designed to improve access to school services for preschool children with developmental delays or disabilities. The program aims to better connect families with necessary education and healthcare services while addressing disparities related to race, ethnicity, and income. It involves two groups: one will use the new linkage model, and the other will continue with their usual treatment. Families with children aged 3-5 in Chicago, diagnosed with or at risk for developmental delays and not currently receiving special education services, are a good fit for this trial. As an unphased trial, this study offers families a chance to contribute to innovative solutions that could transform access to essential services.

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 this educational-medical linkage model is safe?

Research shows that the "Preschool and Me" (PreM) program is practical and well-liked by families. Studies have found that PreM helps families understand early childhood special education. This indicates the program is safe and suitable for communities, especially those with historically marginalized groups. Studies have reported no negative effects. Therefore, participants can feel confident about the safety of joining this program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Preschool and Me" intervention because it offers a unique, educational approach to addressing developmental delays in preschool-aged children. Unlike traditional therapies that might focus on medical or therapeutic interventions, this method emphasizes early childhood education and social engagement as a way to support developmental progress. By integrating learning and social interaction into a structured preschool setting, "Preschool and Me" aims to provide a holistic environment that nurtures growth and development in a naturalistic setting. This could lead to improvements that are not only effective but also enjoyable and engaging for young children.

What evidence suggests that the Preschool and Me linkage model is effective for improving access to school-based services for preschool children with developmental delays?

Research shows that the Preschool and Me (PreM) program may assist families with preschool children who have developmental delays. In this trial, participants in the "Linkage Model" arm will receive the PreM intervention. Studies have found that PreM simplifies access to school services and enhances parent-child interactions. For instance, parents reported spending more time engaging in activities and conversing with their children. Families in the program experienced less stress and improved in achieving goals for their children. These results suggest that PreM could benefit both children and parents in navigating school and medical services. ^{1 2 3 4 6}

Who Is on the Research Team?

Reshma Shah, MD, MPH

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for families with preschool-aged children (36-59 months old by September 1 of the current school year) who have developmental delays or disabilities, or are at risk. To join, kids must screen positive for developmental issues and not be receiving special education services.

Inclusion Criteria

Child is not receiving any ECSE services

My child is between 3 and 5 years old and eligible for ECSE in Illinois.

Child is diagnosed with a developmental delay or disability (DD) or determined to be at risk for DD (clinical concerns raised by primary care provider/healthcare provider or by parents at the time of enrollment)

Exclusion Criteria

If child meets inclusion criteria, no other exclusion criteria will be applied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Preschool and Me (PreM) intervention or are placed in a waitlist control arm for 6 months

6 months

4 visits (remote data collection at baseline, 3, 6, and 12 months)

Follow-up

Participants are monitored for outcomes related to child, parent, family, and health service improvements

12 months

Data collection at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Preschool and Me

Trial Overview The study tests 'Preschool and Me' (PreM), a program linking educational support with medical care to improve access to school-based services for these children while addressing healthcare disparities.

How Is the Trial Designed?

Group I: Linkage Model Experimental Treatment 1 Intervention

Preschool and Me intervention

Group II: Treatment as Usual Active Control 1 Intervention

Preschool and Me intervention is not used

Preschool and Me is already approved in United States for the following indications:

Approved in United States as Preschool and Me for:

• Developmental delays and disabilities in preschool-aged children

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Over a 38-month period, drug therapy was linked to an average of 243 reported deaths annually in infants and young children under 2 years old, with a significant number occurring in the first month and year of life.

A substantial portion of adverse events (24%) were associated with drug exposure from the mother during pregnancy, delivery, or lactation, highlighting the need for careful consideration of medication risks during this critical period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reported adverse drug events in infants and children under 2 years of age. Moore, TJ., Weiss, SR., Kaplan, S., et al.[2022]

A survey conducted by a French national health insurance branch revealed that many children are at risk of experiencing severe adverse effects from treatments intended for mild disorders.

This highlights a potential safety concern regarding the over-medication of children for conditions that may not require such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dangerous paediatric prescriptions. [2009]

A review of 11 studies found that most interventions (9 out of 11) significantly improved fundamental movement skills (FMS) in preschoolers with developmental delay, with a large effect size indicating strong efficacy.

Interventions lasted between 8 to 24 weeks and provided substantial instruction time, suggesting that structured programs can effectively enhance movement skills in this population, but future studies should involve parents and teachers for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor skill interventions to improve fundamental movement skills of preschoolers with developmental delay. Kirk, MA., Rhodes, RE.[2019]

From 2003 to 2008, only 6% of adverse event reports to the FDA involved children, indicating a need for improved pediatric drug safety monitoring despite steady reporting rates for pediatric adverse events.

Certain drug classes, such as anticonvulsants and ADHD medications, were frequently reported in children but not in adults, highlighting the unique safety concerns and the necessity for targeted surveillance in pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: an overview of reports, 2003-2007. Johann-Liang, R., Wyeth, J., Chen, M., et al.[2013]

Multidisciplinary teams are more effective in managing children with developmental delays than individual approaches, emphasizing the need for a comprehensive view of the child's development.

Early intervention programs that involve parents and focus on home-based strategies are beneficial, but there is still uncertainty about their long-term effectiveness, particularly for children with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of early intervention: a critical review. Parry, TS.[2019]

Moderate preterm infants (born at 32-35 weeks) showed a 2-fold higher prevalence of developmental delay compared to full-term infants (4.2% vs. 8.3%), while early preterm infants (born before 32 weeks) had the highest prevalence at 14.9%.

Both moderate and early preterm infants experienced more difficulties in fine motor, communication, and personal-social skills compared to full-term infants, but moderate preterm infants did not show increased issues with gross motor skills or problem-solving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developmental delay in moderately preterm-born children at school entry. Kerstjens, JM., de Winter, AF., Bocca-Tjeertes, IF., et al.[2015]

In a study of preschool teachers and principals, 10.8% of children were identified as having special needs, highlighting the importance of early detection and support for developmental disorders.

Effective support for parents of children with special needs was linked to strong communication about developmental issues, collaboration with other professionals, and reflective practices during teacher-parent conferences, suggesting that enhancing these areas could improve support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Factors related to support provided by preschool personnel for parents rearing children with special needs: Focus on communicating about the child's developmental problems]. Sato, H., Taguchi, A., Yamaguchi, T., et al.[2019]

In a study of 1,785 preschool children referred for early intervention (EI) in Zurich, Switzerland, primary care physicians (PCPs) successfully identified over 90% of children needing EI during well-child visits, highlighting the importance of these visits for early detection of developmental delays (DD).

Despite the effectiveness of well-child visits, 88.7% of PCPs reported that parents were hesitant to accept further evaluation or support, indicating a need for better communication to encourage parents to pursue necessary interventions for their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of well-child visits in detecting developmental delay in preschool children. Moser, M., Müllner, C., Ferro, P., et al.[2023]

In a study of 192 preschool children, 89% exhibited sleep problems, which were significantly correlated with developmental delays, particularly in preterm children.

The findings suggest that addressing sleep disturbances is crucial during evaluations for developmental delays, as improving sleep quality may enhance the effectiveness of early intervention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep problems in preschool children at the child development center with different developmental status: A questionnaire survey. Kuok, CM., Liu, JR., Liang, JS., et al.[2022]

The LEaP playgroup showed significant improvements in parenting distress and goal achievement for children with developmental delays after 8 weeks, with notable benefits continuing up to 28 weeks.

While LEaP did not show significant differences compared to the control group overall, it did lead to better outcomes in child performance and family support at both 12 and 28 weeks, suggesting it may be a helpful intervention for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised Controlled Trial of a Therapeutic Playgroup for Children with Developmental Delays. Armstrong, J., Girdler, S., Davidson, E., et al.[2021]

From 2008 to 2012, the FDA recorded 113,077 adverse drug reactions (ADRs) in pediatric patients, with the majority of reports coming from medical doctors (32%) and consumers (26%).

The most commonly reported ADRs included pyrexia, convulsions, vomiting, and accidental overdoses, particularly associated with drugs affecting the nervous system and antineoplastic/immunomodulating agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System Database of the Food and Drug Administration. Bigi, C., Tuccori, M., Bocci, G.[2022]

After 8 months of treatment, preschoolers with mild behavioral disorders showed significant developmental, language, and behavioral improvements in a specialized therapeutic preschool compared to similar children in regular daycare centers.

The study highlights the effectiveness of well-resourced and specialized programs in supporting the development of children with behavioral challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural and developmental gains made in a therapeutic preschool and an integrated day care program: a pilot study. Bradley, SJ., Kolers, N., Cohen, N.[2019]

Out of 2,046 preschool children with developmental delays, only 26% were in regular education by third grade, while 74% required special education services, indicating a significant need for support.

Children in regular education had higher retention rates compared to the general population, suggesting that early intervention may lead to better long-term educational outcomes for some children with developmental delays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tracking preschool children with developmental delay: third grade outcomes. Delgado, CE., Vagi, SJ., Scott, KG.[2019]

The Best Pharmaceuticals for Children Act (BPCA) incentivizes pharmaceutical companies to study drugs for children by offering six months of marketing exclusivity, which helps ensure that medications are safe and effective for pediatric use.

The FDA's review of adverse events related to drugs with pediatric exclusivity has generally found no unexpected safety issues, but it has also identified important safety information in certain cases, enhancing the overall safety profile of medications for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety monitoring of drugs granted exclusivity under the Best Pharmaceuticals for Children Act: what the FDA has learned. Mathis, LL., Iyasu, S.[2013]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424001595

Preschool and Me: Educational-clinical linkage to improve ... The prevalence of developmental delays and disabilities among children living in the United States (US) is staggering, affecting 1 in 10 preschool-age children ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38602783/

Facilitating coordination between medical and educational ... Our findings suggest PreM was feasible, acceptable, and demonstrated promise in supporting families to navigate the ECSE process.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39759566/

Preschool and Me: Educational-clinical linkage to improve ... Our specific aims are to test the effectiveness of PreM on access to school-based services as well as health service outcomes; examine mediators ...

4. researchgate.net researchgate.net/publication/386588215_Preschool_and_Me_Educational-Clinical_Linkage_to_Improve_Health_Equity_for_Children_with_Developmental_Delays_and_Disabilities_from_Historically_Marginalized_Communities

(PDF) Preschool and Me: Educational-Clinical Linkage to ... Results: There was a significant improvement in parent-child stimulation activities and verbal interactions in the intervention group compared ...

5. withpower.com withpower.com/trial/preschool-and-me-for-developmental-delay-d73a5

Preschool and Me for Developmental Delay (PreM Trial) The LEaP playgroup showed significant improvements in parenting distress and goal achievement for children with developmental delays after 8 weeks, with notable ...

6. reddit.com reddit.com/r/ScienceBasedParenting/comments/1oey9f8/preterm_birth_disability_risk_by_week/

Pre-term birth disability risk by week? The risks go down dramatically if you can make it to 28 weeks. This study has tables for various disabilities between 23 weeks to term. The risk ...