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

Evidence-based Intervention Enhancements to Reduce Language Delays and Disorders Among Children of Parents With Substance Use Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use Disorders; Language Disorders in Children; Language Development; Language Delay; Prevention Intervention
• Intervention / Treatment: Behavioral: Comilia Group; Behavioral: Interaction Review Enhancement; Behavioral: Practical Support Enhancement

Detailed Description

The investigators will recruit and randomize a total of N=244 parent-child dyads to one of four treatment conditions using a 2x2 factorial design. Specifically, all participants will receive the group-based intervention from "Learn and Play Every Day" parent-implemented naturalistic communication intervention (PI-NCI) and will be randomized to receive the additional intervention modalities of (1) parental coaching, (2) individualized lessons, (3) both, or (4) neither. The investigators will recruit participants from community agencies that provide support to adults with substance use disorders. Participants will be parents of a child between 18 and 42 months old and who have either a history of substance use disorder or active use within the last year (see Protection of Human Subjects for details). Parent coaching and individualized lesson intervention modalities will be conducted via telehealth. The investigators will randomize parents to intervention modality at the participant level through permuted blocks. The investigators will stratify randomization by the parent's primary language (English vs. Spanish) to ensure balance on this factor. Participant randomization will be masked to the interventionists delivering the group-based intervention. Interventionists delivering the coaching and individualized lesson modalities will not be aware of the presence or absence of the other intervention component. The investigators will collect information about parent responsivity and child language at baseline (T1, prior to receiving the intervention, immediately following the intervention (T2, 2 months), and at two follow-up assessments (T3, 4 months; T4, 8 months). Our primary analysis will compare pre-post gains in parent responsivity and child language comparisons between baseline and follow-up assessments. Parent-child interactions will be video recorded and then outcomes will be coded by trained staff, whereas child performance on the dynamic assessment task and parent performance on the functional cognitive-communication assessment will be scored in real-time by the data collector. Other self-reported measures such as demographics and substance use history will be collected through electronic survey software and stored on a secure server. The primary outcome of interest is parental responsivity, which is measured by the number of parental responses to intentional communicative acts from their child per minute. The secondary outcome of interest is child vocabulary (receptive and expressive). Additional outcomes include parenting knowledge and self-efficacy as well as secondary child outcomes such as rate of communication, sentence diversity, and language learning skill on the dynamic assessment task. Our primary interest (Aim 1a) is to compare the effectiveness of intervention modalities. The investigators will model changes in responsivity at two months post-baseline, as well as other outcomes, as a function of the intervention modalities and their interaction using generalized linear models adjusting for outcome values at baseline. Hypothesis tests will be conducted on the difference in outcome of each intervention modality from the mean of group means. Our overall judgment of the component will be primarily dependent on the component's effect on parental responsivity, but investigators will also take into account the effects on other parent and child outcomes. The investigators will conduct an intent-to-treat analysis, grouping participants by their treatment condition randomizations regardless of the fidelity of the intervention delivered. The effectiveness of an intervention can be undermined if it is difficult to administer or unacceptable to potential recipients. As a result, the investigators will collect feedback from parents, interventionists, and community partners through surveys and interviews. The questions posed will focus on evaluating the reach, acceptability, appropriateness, and fidelity of the intervention delivery (Aim 1b). The investigators will summarize and review the responses and use it to inform the interpretation of the results across Aim 1a and 1b. For example, if the interventions are found to be arduous to implement or unappealing to participants, this will be used to interpret the efficacy findings in context. In addition to assessing the efficacy and implementation of PI-NCI modalities, the investigators will assess differential treatment response and the mechanisms through which the intervention modalities function (Aim 2). The intervention modalities may not be equally effective across various psycho-social dimensions which may give opportunities for personalized treatment. Thus, investigators will assess the interactions (effect moderation) between the interventions and parental psychopathology, cognitive communicative impairment, social determinants of health on parental outcomes as well as prenatal exposure to substances on child outcomes. It is also important to understand how our interventions improve parental responsivity and other parent/child outcomes. Indeed, the investigators hypothesize that these interventions first improve parenting self-efficacy and knowledge, which in turn improves outcomes. Our analyses of mediators will use full information structural equation models to adjusted for baseline values and unbalanced covariates and the investigators will model moderators using similarly specified linear models. Our moderation analyses will assess the interaction terms between intervention components and our mediation analysis will examine the indirect effect of treatment modalities on outcomes through parenting efficacy and knowledge.

• Study Type: Interventional
• Enrollment (Estimated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie De Anda, PhD, CCC-SLP; Phone Number: 541-346-8530; Email: sdeanda@uoregon.edu
• Study Contact Backup: Name: Maya Casper; Phone Number: 775-848-8727; Email: mcasper@uoregon.edu

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • Recruiting
      • Prevention Science Institute
      • Contact: Maya Casper; Phone Number: 775-848-8727; Email: mcasper@uoregon.edu
      • Contact: Stephanie De Anda; Phone Number: 541-346-8530; Email: sdeanda@uoregon.edu
      • Principal Investigator: Camille Cioffi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interaction Review Enhancement & Practical Supports Enhancement; Participants receive the Comilia Group intervention plus the interaction review sessions and practical support sessions.	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.
Active Comparator: Comilia Group Only; Participants receive the Comilia Group intervention only.	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.
Active Comparator: Interaction Review Enhancement; Participants receive the Comilia Group intervention plus the Interaction Review Enhancement.	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.
Active Comparator: Practical Support Enhancement; Participants receive the Comilia Group intervention plus the Practical Support Enhancement.	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent responsivity	Rate-based measure that describes parent responses to child intentional communication acts.	Baseline, 2 months, 4 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receptive and expressive vocabulary	Will be assessed using the MacArthur Bates Communicative Development Inventory: specifically the Dual Language Learners English-Spanish Inventories.	Baseline, 2 months, 4 months and 6 months

Collaborators and Investigators

• Sponsor: University of Oregon
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Camille Cioffi, Prevention Science Institute

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2029

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Parenting; Naturalistic communication intervention; Group based intervention; Vocabulary Acquisition
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Chemically-Induced Disorders; Communication Disorders; Language Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Substance-Related Disorders; Language Development Disorders
• Other Study ID Numbers: STUDY00002032; R01DC022028 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All quantitative experimental data produced during the course of the project will be preserved and shared.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No