Early Intervention Approaches for Developmental Delay

LS
Overseen ByLaura Sudec, Masters
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three methods of delivering speech therapy for toddlers with developmental disabilities. One group will have a therapist work directly with the child (Therapist-Delivered Early Intervention Approach). Another group will have the therapist coach the caregiver (Caregiver Coaching Early Intervention Approach). A third group will combine both approaches with an additional parent-led program (Parents Taking Action). The aim is to determine which method improves communication in children. Toddlers new to speech therapy in the Illinois Early Intervention system, who have not been exposed to languages other than English or Spanish more than 10% of the time, might be a good fit. As an unphased trial, this study provides families with a unique opportunity to explore innovative speech therapy methods tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It focuses on speech therapy approaches for children with developmental delays.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that early intervention (EI) methods for children with developmental delays are safe. Studies on EI provided by therapists have demonstrated positive effects on children's movement and sensory skills, creating a more stimulating home environment. This indicates that EI is well-tolerated without major side effects.

An initial study on the caregiver coaching method found improvements in caregiver interactions and the child's social skills. This suggests that coaching is safe and beneficial for both caregivers and children.

The Parents Taking Action program, which promotes caregiver involvement in EI, has been linked to positive outcomes for at-risk children, with no reported safety issues. This program empowers parents to play a more active role in their child's development, ensuring safety and effectiveness.

Overall, these methods support children's growth without safety risks. They focus on helping children through planned activities and caregiver involvement, which have proven effective and well-received.12345

Why are researchers excited about this trial?

Researchers are excited about these early intervention approaches for developmental delay because they focus on empowering caregivers and involving parents actively, which is a shift from traditional therapist-only methods. The Caregiver Coaching Early Intervention Approach stands out by training parents to deliver therapies, fostering skill-building at home and potentially leading to more sustainable progress. Meanwhile, the Combined Early Intervention Approach incorporates both therapist guidance and active parent participation, offering a comprehensive strategy that leverages the strengths of both professional expertise and parental involvement. This focus on family-centered care could lead to more personalized and effective developmental support for children.

What evidence suggests that this trial's early intervention approaches could be effective for developmental delay?

This trial will compare different early intervention approaches for developmental delay. Studies have shown that early intervention (EI) services improve development in children with delays. In this trial, one group will receive the Therapist-Delivered Early Intervention Approach, which often enhances language and social skills. Another group will receive the Caregiver Coaching Early Intervention Approach; research shows that when parents are coached, they feel more confident and can better support their child's development. Additionally, the trial includes a combined approach with Parents Taking Action, which involves parents directly and has shown positive effects on child development. These methods aim to boost communication skills and overall growth in children with developmental disabilities.678910

Who Is on the Research Team?

MR

Megan Roberts, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for toddlers with developmental delays, including coordination and speech issues. It's designed to help those who are already enrolled in Early Intervention (EI) speech therapy. To participate, children must meet certain developmental criteria but specific inclusion and exclusion details aren't provided here.

Inclusion Criteria

My child is between 13 and 27 months old.
Enrolled in the Illinois Early Intervention system and newly eligible for speech-language therapy (i.e., no prior EI speech-language therapy experience)
I plan to have weekly speech therapy in my home or another private place.

Exclusion Criteria

I am regularly exposed to a language other than English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three Early Intervention approaches: Therapist Delivered EI, Caregiver Coaching EI, or Combined EI Approach + Parent-Led Education Program

28 weeks
Weekly sessions

Follow-up

Participants are monitored for caregiver responsiveness, family outcomes, and child communication skills

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Caregiver Coaching Early Intervention Approach
  • Parents Taking Action
  • Therapist-Delivered Early Intervention Approach
Trial Overview The study compares three EI approaches: direct therapist intervention, caregiver coaching by a therapist, and a combined approach with parent-led education. Over 28 weeks, it aims to find the most effective method for improving communication skills in toddlers with developmental disabilities.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Combined Early Intervention Approach + Parents Taking ActionExperimental Treatment3 Interventions
Group II: Caregiver Coaching Early Intervention ApproachExperimental Treatment1 Intervention
Group III: Therapist-Delivered Early Intervention ApproachActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Boston College

Collaborator

Trials
40
Recruited
49,300+

North Carolina State University

Collaborator

Trials
38
Recruited
50,000+

University of Texas at Austin

Collaborator

Trials
387
Recruited
86,100+

Citations

Use of telemediated caregiver coaching to increase access to ...In this article, we provide an overview of a statewide model developed to increase access to naturalistic developmental behavioral interventions for families.
Empower EI: Comparing Early Intervention Approaches to ...Outcomes will assess both caregiver and child domains, including caregiver responsiveness, caregiver capacity to support the child's needs, and ...
Caregiver Coaching in Early Intervention: A Scoping ReviewThis scoping review explores existing research on coaching interventions and models used by occupational therapists in EI.
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.
Factors That Contributed to Early Intervention Providers' ...Caregiver coaching in early intervention (EI) can lead to positive outcomes for young children with delays and disabilities and their ...
Surveying Early Intervention Providers to Identify ...Children with developmental delay are more likely than their same-aged peers to develop problems with social-emotional and behavioral functioning (Dyck & Piek, ...
A pilot evaluation of the Baby Social ABCs caregiver ...Results: Caregiver implementation fidelity increased significantly, along with infant responsivity and social communication behaviors (social orienting, shared ...
Long‐Term Neurodevelopmental Outcomes of the SAFE ...This study revealed that the SAFE early intervention approach applied to infants at risk of CP in the first year of life had more positive and ...
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, ...
Brief Report: Assessment of a Caregiver-Implemented ...This pilot study examined outcomes for toddlers and young children with ASD or ASD symptomatology following SIAT, a 4-week caregiver coaching ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security