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Prevent Language Delays and Disorders Among Children of Caregivers With Substance Use Disorders With Community Groups and Individualized Services

NCT07529327 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2026-04-20

No results posted yet for this study

Summary

The goal of this clinical trial is to test ways to improve early language development among young children of parents with substance use disorder (SUD). Children of parents with SUD are at increased risk for language delays, and early supports may help prevent long-term learning challenges. This study will examine whether adding additional supports to group-based parenting intervention improves child language outcomes compared to the group intervention alone.

Conditions

  • Language Delay
  • Substance Use Disorders
  • Language Disorders in Children
  • Language Development
  • Prevention Intervention

Interventions

BEHAVIORAL

Comilia Group

Parents participate in six weekly 90-minute in-person groups led by a trained facilitator and offered in English or Spanish. Groups use modeled caregiver-child interaction videos and guided discussion to teach evidence-based communication strategies.

BEHAVIORAL

Interaction Review Enhancement

Parents receive three one-hour telehealth coaching sessions with a licensed speech-language pathologist to review caregiver-child interactions, practice communication strategies, and receive individualized feedback.

BEHAVIORAL

Practical Support Enhancement

Participants receive three one-hour telehealth sessions focused on identifying barriers to using the communication strategies introduced in the group sessions. Interventionists work with parents to develop structured supports (e.g., mindfulness tools, visual aids, tracking logs, timers) and set goals to address planning, attention, or memory challenges that may interfere with implementation.

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • University of Oregon

    lead OTHER

Principal Investigators

  • Camille Cioffi · Prevention Science Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-10
Primary Completion
2028-11-30
Completion
2029-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07529327 on ClinicalTrials.gov