NCT07529327 · University of Oregon
Prevent Language Delays and Disorders Among Children of Caregivers With Substance Use Disorders With Community Groups and Individualized Services
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Parent responsivity
Time frame: Baseline, 2 months, 4 months and 6 months
Rate-based measure that describes parent responses to child intentional communication acts.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Zoom meetings
- Be 18 years of age or older
Exclusion criteria
- -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.
Where
- Eugene, Oregon
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations