Coaching Program for Developmental Delay

Overseen By Lauren M Little, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Early intervention >1 hour/week

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a coaching program designed to assist caregivers of young children experiencing homelessness and developmental delays. The program, known as caregiver coaching, offers strategies from a speech-language pathologist to support child development. Researchers seek to evaluate the program's effectiveness, cost-efficiency, and acceptability to families and shelter staff. If a child is experiencing housing instability and has screened positive for developmental delays, this trial might be suitable. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could benefit families facing similar challenges.

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 coaching program is safe for children experiencing homelessness?

Research shows that caregiver coaching is generally safe and well-received. Studies have found that these programs can greatly improve caregivers' well-being. For instance, one study found that teaching parents through these programs reduces stress and enhances parenting skills. Another study showed positive results for caregivers who use methods to help children manage their emotions.

Reports of serious negative effects from caregiver coaching are absent, suggesting it is a low-risk option. These programs focus on supporting caregivers, which also aids children's development. Overall, caregiver coaching appears safe based on current research and may benefit both caregivers and children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the caregiver coaching program for developmental delay because it directly empowers caregivers with practical strategies to support their child's development. Unlike traditional therapies that often rely on direct intervention by specialists, this approach involves training caregivers themselves, making it more accessible and personalized. By involving a speech-language pathologist to guide caregivers, the program taps into the everyday interactions that naturally occur between a caregiver and child, potentially leading to more sustainable and impactful developmental progress. This method could bridge gaps in access to professional care and provide continuous developmental support in a child's home environment.

What evidence suggests that this caregiver coaching is effective for developmental delay?

Research has shown that coaching for caregivers can effectively support child development, especially for children with developmental delays. In this trial, participants will receive a caregiver coaching intervention, where a speech-language pathologist offers strategies to support child development. Studies have found that coaching helps caregivers improve their problem-solving and communication skills, boosting their confidence in assisting their children. Another study found that caregiver coaching helps parents guide their children's emotions and behaviors. For toddlers with autism, coaching has helped parents use teaching methods that support their child's learning. These findings suggest that caregiver coaching can be a helpful approach for children with developmental challenges. ^{1 2 6 7 8}

Who Is on the Research Team?

Lauren M Little, PhD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for young children who are currently without a stable home and have been identified as having developmental delays. To participate, they should not be receiving more than one hour per week of early intervention services.

Inclusion Criteria

Children must be unhoused or experience housing instability and screen positive for developmental delay

Exclusion Criteria

My child does not receive more than 1 hour of early intervention weekly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week shelter-based caregiver coaching intervention

12 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Caregiver coaching

Trial Overview The study is testing a coaching program designed to support caregivers of children experiencing homelessness with developmental delays. It aims to assess the cost-effectiveness, potential benefits, and how well caregivers and shelter staff receive the program.

How Is the Trial Designed?

Group I: Caregiver Coaching Experimental Treatment 1 Intervention

In this arm, participants receive a caregiver coaching intervention. In the intervention, a speech language pathologist offers strategies to support child development.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12223970/

Caregiver capabilities: Healthcare interventions for ... The most effective interventions incrementally develop caregivers' problem-solving skills, communication strategies and self-confidence, ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/19411243.2025.2542566?src=

Caregiver coaching: Promoting co-regulation with toddlers ... Data from open-ended questions revealed positive outcomes for caregivers regarding the use of co-regulation strategies and perceptions of the coaching model.

3. publications.aap.org publications.aap.org/pediatrics/article/156/5/e2025071644/204535/Sustained-Effectiveness-of-a-211-Call-Center-With

Sustained Effectiveness of a 211 Call Center With Early ... This study showed that children assigned to the 211 intervention group received services sooner than children assigned to usual care alone and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885200624001479

Caregivers' perceptions on caregiver-implemented ... This study aimed to explore caregivers' perceptions of their experiences as intervention agents for their young children with delays and/or disabilities.

5. pubs.asha.org pubs.asha.org/doi/10.1044/2023_AJSLP-23-00279

A Caregiver-Mediated Intervention for Toddlers With Autism An adaptive telehealth coaching model is effective for teaching caregivers of toddlers with autism to implement EMT and potentially helps to bridge the gap.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11656621/

Use of telemediated caregiver coaching to increase access ... In this article, we provide an overview of a statewide model developed to increase access to naturalistic developmental behavioral interventions for families.

7. journals.lww.com journals.lww.com/iycjournal/fulltext/2024/04000/factors_associated_with_caregiver_reporting_of.4.aspx

Factors Associated With Caregiver Reporting of... The purpose of this study is to examine the factors associated with caregivers' perception of child developmental concerns in low-income communities.

8. ies.ed.gov ies.ed.gov/use-work/awards/embedded-practices-and-intervention-caregivers-epic

Embedded Practices and Intervention with Caregivers (EPIC) Key outcomes include provider measures of coaching strategies and social validity, as well as caregiver measures of parenting self-efficacy, social validity, ...