What this study is
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.
What's being tested
- Comilia Group
Intervention · 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
Intervention · 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
Intervention · 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
- Official title
- Evidence-based Intervention Enhancements to Reduce Language Delays and Disorders Among Children of Parents With Substance Use Disorders
- Sponsor
- University of Oregon
- Conditions
- Language Delay · Substance Use Disorders · Language Disorders in Children · Language Development · Prevention Intervention
- Enrolling
- 244 people
- Starts
- 2026-03-10
- Est. completion
- 2029-11-30
- Design
- Single-blind, randomized, factorial
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Have a:; Self-reported lifetime history of substance use disorder treatment and/or; active substance use in the past year
- Be providing care for/parenting a child at least 10% of the time who is:; between the ages of 12-42 months; English/Spanish bilingual or monolingual in English or Spanish; exposed to a third language once a week or less; not yet combining three or more words regularly; has less than 150 words in their expressive vocabulary
- Be able to provide consent for their target child to participate, or have a legal guardian provide consent for the child to participate
- Be able to speak and understand English and/or Spanish
- Be willing to attend groups once a week for six weeks at a participating site/group time
- If assigned additional services, willing to attend virtual meetings
- Be 18 years of age or older
You can't join if
- Only one caregiver per focal child can participate in the research study. Caregivers whose participating child already has another caregiver enrolled in the research study will not be eligible to participate.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openPrevention Science Institute
Eugene, Oregon, United States
- Stephanie De Anda · Contact541-346-8530sdeanda@uoregon.edu
- Maya Casper · Contact775-848-8727mcasper@uoregon.edu
- Camille Cioffi · Principal investigator
Recruiting
Study team
Sponsor
University of Oregon
Study ID STUDY00002032
Principal investigator
Camille Cioffi
Prevention Science Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.