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

Trial Summary

What is the purpose of this trial?

This proposal aims to test whether a proposed community-clinical linkage (CCL), an educational-medical linkage model, improves access to school-based services and subsequent child, parent, family and health service outcomes and offers a promising strategy to address longstanding racial, ethnic and income health care disparities among families with preschool children with developmental delays and disabilities. The investigators designed an educational-clinical linkage model, Preschool and Me (PreM) which incorporates key components of a CCL. It also utilizes a personalized medical-education care plan with remote lay navigator support to increase access to school-based 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 data supports the effectiveness of the treatment Preschool and Me (PreM) for developmental delay?

Research shows that similar programs, like the LEaP playgroup, can improve family support and goal achievement for children with developmental delays. Additionally, early intervention programs that involve parents and focus on the child's overall development have been found to be effective in offering parental support and improving parent-child relationships. ^{1 2 3 4 5}

Is Preschool and Me safe for children?

The safety of treatments like Preschool and Me has been monitored by the FDA, and in most cases, no unexpected adverse events were reported in children. However, some treatments for mild disorders have been linked to severe adverse effects, so it's important to consult with healthcare professionals. ^{6 7 8 9 10}

How is the treatment 'Preschool and Me' unique for developmental delay?

The 'Preschool and Me' treatment is unique because it focuses on early intervention and support at the preschool level, involving collaboration between preschool teachers and parents to address developmental delays, which is different from traditional medical or therapeutic approaches. ^{5 11 12 13 14}

Research Team

Reshma Shah, MD, MPH

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Randomised Controlled Trial of a Therapeutic Playgroup for Children with Developmental Delays. [2021]

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

Behavioural and developmental gains made in a therapeutic preschool and an integrated day care program: a pilot study. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

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

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

Motor skill interventions to improve fundamental movement skills of preschoolers with developmental delay. [2019]

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

Tracking preschool children with developmental delay: third grade outcomes. [2019]

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

Reported adverse drug events in infants and children under 2 years of age. [2022]

7. Italy 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. [2022]

8. England 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. [2013]

9. France pubmed.ncbi.nlm.nih.gov

Dangerous paediatric prescriptions. [2009]

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

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

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

Developmental delay in moderately preterm-born children at school entry. [2015]

12. Japan 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]. [2019]

13. England pubmed.ncbi.nlm.nih.gov

The role of well-child visits in detecting developmental delay in preschool children. [2023]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Sleep problems in preschool children at the child development center with different developmental status: A questionnaire survey. [2022]