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

ConditionsLanguage DelaySubstance Use DisordersLanguage Disorders in ChildrenLanguage DevelopmentPrevention Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oregon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Self-reported lifetime history of substance use disorder treatment and/or

active substance use in the past year

between the ages of 12-42 months

English/Spanish bilingual or monolingual in English or Spanish

Disqualifiers

None

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

244 Participants
are divided into 4 treatment groups
Group A: Interaction Review Enhancement & Practical Supports EnhancementActive comparator 3 interventions
Group B: Comilia Group OnlyActive comparator 1 intervention
Group C: Interaction Review EnhancementActive comparator 2 interventions
Group D: Practical Support EnhancementActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Parent responsivity

Rate-based measure that describes parent responses to child intentional communication acts.

Time frame
Baseline, 2 months, 4 months and 6 months

Secondary outcomes

1

Receptive and expressive vocabulary

Will be assessed using the MacArthur Bates Communicative Development Inventory: specifically the Dual Language Learners English-Spanish Inventories.

Time frame
Baseline, 2 months, 4 months and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oregon

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov
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