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Developmental DelayNCT06347666

Coaching in Early Development Project

A study testing Caregiver coaching in people with Developmental Delay, run by Rush University Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Among young children, homelessness is an independent predictor of child developmental delay and disability, and children experiencing homelessness (CEH) are 2-4x more likely to demonstrate developmental delays compared to housed children. Read more about this study

Who is it for?
Ages 12 months to 6 yearsHealthy volunteers can take part
Conditions the study is for
Developmental Delay
What is being tested?
Caregiver coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
12 Jan 2024to 26 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • Children are excluded if they are receiving more than 1 hour/week of early intervention

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rush University Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Equity-focused Implementation of Caregiver Coaching for Unhoused Children At-risk for Developmental Delay

Among young children, homelessness is an independent predictor of child developmental delay and disability, and children experiencing homelessness (CEH) are 2-4x more likely to demonstrate developmental delays compared to housed children. The purpose of this project is to evaluate an evidence-based model of caregiver coaching for CEH that screen positive for developmental delay. The investigators will also evaluate the societal costs of the program, its preliminary efficacy, and the acceptability among caregivers and shelter staff.

Read the detailed description

Over 2.5 million children experience homelessness (CEH) in a given year and housing intersects with inequities due to race and disability. Among young children, homelessness is an independent predictor of child developmental delay and disability, and CEH are 2-4x more likely to demonstrate developmental delays compared to housed children. Caregiver coaching is an evidence-based and effective behavioral therapy method to support child development and has been recommended by the American Academy of Pediatrics for adoption across all early intervention (EI) systems. EI is mandated by states under the Individuals with Disabilities Education Act (IDEA) Part C and provides behavioral therapy for all children ages 0-3 years that show developmental delay. Within EI, caregiver coaching is delivered is delivered in families' homes, and therefore has limited evaluation of implementation in shelters. In ongoing pilot work, in collaboration with shelter-based primary care, 70% of CEH screened positive for developmental delay, yet no child received caregiver coaching through EI. Therefore, the objective of this proposal is to use a Type II Hybrid Trial to investigate how implementation strategies influence uptake of shelter-based caregiver coaching and subsequent child outcomes. The proposed study will use implementation research as a guide to evaluate our team's implementation of caregiver coaching from an equity lens among a population that consistently lacks access to evidence-based interventions to improve children's developmental trajectories. Specifically, the investigators will 1) Evaluate implementation of a 12-week shelter-based caregiver coaching intervention on caregiver attendance and fidelity (i.e., adherence) among CEH with delay ages compared to statewide equity metrics; 2) Evaluate the societal costs of implementing a 12-week shelter-based caregiver coaching intervention; 3) Investigate facilitators and barriers related to attendance and fidelity of a 12-week coaching intervention among caregivers of CEH and shelter staff; 4) Explore the efficacy of the 12-week coaching intervention on caregiver and child outcomes. While disparities in access to evidence-based developmental care for CEH is documented, the investigators will identify how strategies that promote equity in access result in caregiver uptake and costs. By evaluating stakeholder feedback of an evidence-based intervention not yet tested in shelters, the investigators can integrate changes to the model for future trials. The impact will be on prioritizing ways to promote uptake of tailored developmental interventions for children most in need, ultimately contributing to evidence to share with families, shelters, and policymakers to create sustainable models of care.

Being tested
Caregiver coaching
Medical subject headings
Learning Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caregiver coachingBehavioural

    Speech language pathologists will meet with caregivers to talk through strategies to promote child development.

Study groups in NCT06347666
Study groupRoleWhat they receive
Caregiver CoachingExperimentalIn this arm, participants receive a caregiver coaching intervention. In the intervention, a speech language pathologist offers strategies to support child development.
Receives: Behavioral: Caregiver coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parenting Sense of Competence Scale

    Self-report of satisfaction and efficacy associated with parenting. Higher scores mean that a respondent has higher parenting sense of competence. Scores range from 6-102.

    Measured: baseline and post-12 week intervention

  2. Parenting Stress Scale

    Self-report of stressors associated with parenting. Higher scores mean higher parenting stress and scores range from 18-90.

    Measured: baseline and post-12 week intervention

Secondary outcomes (2)
  1. Mullen Scales of Early Learning

    Behavioral assessment of overall child development. Scores are presented as standard scores with a mean of 50 and a standard deviation of 10. Higher standard scores mean increased overall development.

    Measured: baseline and post-12 week intervention

  2. Maternal Behavior Responsivity Scale

    Observational assessment of maternal responsivity. Higher scores mean increased maternal responsivity. Scores range from 5-25.

    Measured: baseline and post-12 week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2024
  2. Study start12 Jan 2024
  3. Primary completion26 Mar 2025
  4. Study completion26 Mar 2025

Why it stopped: Funding was terminated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
One group will receive the caregiver coaching intervention.
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06347666
Sponsor's protocol ID
23082905
Status last verified
Apr 2025
First submitted
28 Mar 2024
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared due to the small sample size of the study, leading to potential privacy concerns.

Questions about this trial

What is this clinical trial studying?

A study testing Caregiver coaching in people with Developmental Delay, run by Rush University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Funding was terminated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parenting Sense of Competence Scale (time frame: baseline and post-12 week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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