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

Part of paid clinical trials in Eugene, Oregon.

Sponsor
University of Oregon
Study ID
NCT07529327
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Comilia Group — BEHAVIORAL
    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.
  • Interaction Review Enhancement — BEHAVIORAL
    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.
  • Practical Support Enhancement — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 10, 2026
Status verified
Oct 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
244 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Interaction Review Enhancement & Practical Supports Enhancement
    Participants receive the Comilia Group intervention plus the interaction review sessions and practical support sessions.
  • Active Comparator: Comilia Group Only
    Participants receive the Comilia Group intervention only.
  • Active Comparator: Interaction Review Enhancement
    Participants receive the Comilia Group intervention plus the Interaction Review Enhancement.
  • Active Comparator: Practical Support Enhancement
    Participants receive the Comilia Group intervention plus the Practical Support Enhancement.

Primary Outcome Measure

Parent responsivity [ Time Frame: Baseline, 2 months, 4 months and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Prevention Science InstituteEugeneOregon97403
Stephanie De Anda
[email protected]
541-346-8530
Maya Casper
[email protected]
775-848-8727
Camille Cioffi (PRINCIPAL_INVESTIGATOR)

Find similar trials in Eugene, OR

By research site
Prevention Science Institute· Eugene, OR

Related Studies