Recruiting

Parenting Intervention

Sponsor:

University of Oregon

Code:

NCT07529327

Conditions

Language Delay

Substance Use Disorders

Language Disorders in Children

Language Development

Prevention Intervention

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Comilia Group

Interaction Review Enhancement

Practical Support Enhancement

Study Details

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.

Conditions

Language Delay

Substance Use Disorders

Language Disorders in Children

Language Development

Prevention Intervention

Study ID

NCT07529327

Start date

Mar 10, 2026

Status verified date

Oct, 2025

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Have a:

1. Self-reported lifetime history of substance use disorder treatment and/or
2. active substance use in the past year
2. Be providing care for/parenting a child at least 10% of the time who is:

1. between the ages of 12-42 months
2. English/Spanish bilingual or monolingual in English or Spanish
3. exposed to a third language once a week or less
4. not yet combining three or more words regularly
5. has less than 150 words in their expressive vocabulary
3. Be able to provide consent for their target child to participate, or have a legal guardian provide consent for the child to participate
4. Be able to speak and understand English and/or Spanish
5. Be willing to attend groups once a week for six weeks at a participating site/group time
6. If assigned additional services, willing to attend Zoom meetings
7. 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.

Study Design

Enrollment

244 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

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 measure

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

Central Contacts and Locations

Central contacts

Locations

Prevention Science Institute

Recruiting

Eugene, Oregon, United States, 97403

Contacts

Principal Investigator:

Camille Cioffi

More Information

Sponsor

University of Oregon

Last update posted

Apr 20, 2026

Last verified

Oct, 2025

Keywords

  • Naturalistic communication intervention
  • Parenting
  • Group based intervention
  • Vocabulary Acquisition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oregon on 2026-04-20.