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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Developmental Delay
- 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 group | Role | What they receive |
|---|---|---|
| Caregiver Coaching | Experimental | In 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.
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
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)
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
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.
- First posted4 Apr 2024
- Study start12 Jan 2024
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Why it stopped: Funding was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren M Little, PhD, Principal investigator, Rush University Medical Center
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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equity-focused Implementation of Caregiver Coaching for Unhoused Children At-risk for Developmental Delay
- ClinicalTrials.gov ID
- NCT06347666
- Acronym / sponsor ID
- 23082905
- Conditions
- Developmental Delay
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was terminated.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group will receive the caregiver coaching intervention.
| Arm | Type | Receives |
|---|---|---|
| Caregiver Coaching | Experimental | Behavioral: Caregiver coachingIn this arm, participants receive a caregiver coaching intervention. In the intervention, a speech language pathologist offers strategies to support child development. |
Who may qualify
- Ages
- 12 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children must be unhoused or experience housing instability and screen positive for developmental delay
Key exclusion criteria (1 listed)
- Children are excluded if they are receiving more than 1 hour/week of early intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver coachingSpeech language pathologists will meet with caregivers to talk through strategies to promote child development. | Behavioural | Caregiver Coaching |
Primary outcome
Parenting Sense of Competence Scale
Time frame: baseline and post-12 week intervention
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.
Parenting Stress Scale
Time frame: baseline and post-12 week intervention
Self-report of stressors associated with parenting. Higher scores mean higher parenting stress and scores range from 18-90.
2 secondary outcomes
Mullen Scales of Early Learning
Time frame: baseline and post-12 week intervention
Maternal Behavior Responsivity Scale
Time frame: baseline and post-12 week intervention
Results and safety
The study was stopped early (reason given: Funding was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to the small sample size of the study, leading to potential privacy concerns.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren M Little, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
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.