NCT07529327

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Mar 2026Nov 2029

Study Start

First participant enrolled

March 10, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2029

Last Updated

April 14, 2026

Status Verified

October 1, 2025

Enrollment Period

2.7 years

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Language DelaySubstance Use DisordersLanguage Disorders in ChildrenLanguage DevelopmentPrevention Intervention

Keywords

Naturalistic communication interventionParentingGroup based interventionVocabulary Acquisition

Outcome Measures

Primary Outcomes (1)

  • Parent responsivity

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

    Baseline, 2 months, 4 months and 6 months

Secondary Outcomes (1)

  • Receptive and expressive vocabulary

    Baseline, 2 months, 4 months and 6 months

Study Arms (4)

Interaction Review Enhancement & Practical Supports Enhancement

ACTIVE COMPARATOR

Participants receive the Comilia Group intervention plus the interaction review sessions and practical support sessions.

Behavioral: Comilia GroupBehavioral: Interaction Review EnhancementBehavioral: Practical Support Enhancement

Comilia Group Only

ACTIVE COMPARATOR

Participants receive the Comilia Group intervention only.

Behavioral: Comilia Group

Interaction Review Enhancement

ACTIVE COMPARATOR

Participants receive the Comilia Group intervention plus the Interaction Review Enhancement.

Behavioral: Comilia GroupBehavioral: Interaction Review Enhancement

Practical Support Enhancement

ACTIVE COMPARATOR

Participants receive the Comilia Group intervention plus the Practical Support Enhancement.

Behavioral: Comilia GroupBehavioral: Practical Support Enhancement

Interventions

Comilia GroupBEHAVIORAL

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.

Comilia Group OnlyInteraction Review EnhancementInteraction Review Enhancement & Practical Supports EnhancementPractical Support Enhancement
Interaction Review EnhancementBEHAVIORAL

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.

Interaction Review EnhancementInteraction Review Enhancement & Practical Supports Enhancement
Practical Support EnhancementBEHAVIORAL

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.

Interaction Review Enhancement & Practical Supports EnhancementPractical Support Enhancement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You 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 Zoom meetings
  • Be 18 years of age or older

You may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prevention Science Institute

Eugene, Oregon, 97403, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Language Development DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Study Officials

  • Camille Cioffi

    Prevention Science Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie De Anda, PhD, CCC-SLP

CONTACT

541-346-8530sdeanda@uoregon.edu

Maya Casper

CONTACT

775-848-8727mcasper@uoregon.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Randomized 2x2 factorial experiment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2029

Last Updated

April 14, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

All quantitative experimental data produced during the course of the project will be preserved and shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the end of the funding period.
Access Criteria
IPD will be stored in Databrary. Access to IPD is restricted to researchers who have been authorized by an institution, but broadly shared with all authorized researchers with password access. All shared materials are labeled with a sharing release level that reflects the permission granted by research participants or their parents or guardians.
More information

Locations

US(1)