Language DelayNCT07529327
Prevent Language Delays and Disorders Among Children of Caregivers With Substance Use Disorders With Community Groups and Individualized Services
A study testing Comilia Group, Interaction Review Enhancement and Practical Support Enhancement in people with Language Delay and Substance Use Disorders, run by University of Oregon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Language Delay, Substance Use Disorders, Language Disorders in Children
- What is being tested?
- Comilia Group, Interaction Review Enhancement and Practical Support Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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 virtual meetings
- Be 18 years of age or older
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Prevention Science Institute
Eugene, Oregon, 97403
Stephanie De Anda, 541-346-8530, sdeanda@uoregon.edu
Maya Casper, 775-848-8727, mcasper@uoregon.edu
About this study
Official title: 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.
Read the 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) interaction review, (2) practical supports, (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). Interaction review and practical support 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 interaction review and practical support 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, 6 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.
- Conditions
- Language Delay, Substance Use Disorders, Language Disorders in Children, Language Development, Prevention Intervention
- Being tested
- Comilia Group, Interaction Review Enhancement, Practical Support Enhancement
- Keywords
- Naturalistic communication intervention, Parenting, Group based intervention, Vocabulary Acquisition
- Medical subject headings
- Language Development Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comilia GroupBehavioural
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 EnhancementBehavioural
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 EnhancementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interaction Review Enhancement & Practical Supports Enhancement | Active comparator | Participants receive the Comilia Group intervention plus the interaction review sessions and practical support sessions. Receives: Behavioral: Comilia Group; Behavioral: Interaction Review Enhancement; Behavioral: Practical Support Enhancement |
| Comilia Group Only | Active comparator | Participants receive the Comilia Group intervention only. Receives: Behavioral: Comilia Group |
| Interaction Review Enhancement | Active comparator | Participants receive the Comilia Group intervention plus the Interaction Review Enhancement. Receives: Behavioral: Comilia Group; Behavioral: Interaction Review Enhancement |
| Practical Support Enhancement | Active comparator | Participants receive the Comilia Group intervention plus the Practical Support Enhancement. Receives: Behavioral: Comilia Group; Behavioral: Practical Support Enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent responsivity
Rate-based measure that describes parent responses to child intentional communication acts.
Measured: 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.
Measured: Baseline, 2 months, 4 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start10 Mar 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized 2x2 factorial experiment
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Camille Cioffi, Principal investigator, Prevention Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529327
- Sponsor's protocol ID
- STUDY00002032
- Other IDs
- R01DC022028
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All quantitative experimental data produced during the course of the project will be preserved and shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Intervention Enhancements to Reduce Language Delays and Disorders Among Children of Parents With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT07529327
- Acronym / sponsor ID
- STUDY00002032
- Conditions
- Language Delay, Substance Use Disorders, Language Disorders in Children, Language Development, Prevention Intervention
- Keywords
- Naturalistic communication intervention, Parenting, Group based intervention, Vocabulary Acquisition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) interaction review, (2) practical supports, (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). Interaction review and practical support 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 interaction review and practical support 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, 6 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 4
- Model description
- Randomized 2x2 factorial experiment
| Arm | Type | Receives |
|---|---|---|
| Interaction Review Enhancement & Practical Supports Enhancement | Active comparator | Behavioral: Comilia Group, Behavioral: Interaction Review Enhancement, Behavioral: Practical Support EnhancementParticipants receive the Comilia Group intervention plus the interaction review sessions and practical support sessions. |
| Comilia Group Only | Active comparator | Behavioral: Comilia GroupParticipants receive the Comilia Group intervention only. |
| Interaction Review Enhancement | Active comparator | Behavioral: Comilia Group, Behavioral: Interaction Review EnhancementParticipants receive the Comilia Group intervention plus the Interaction Review Enhancement. |
| Practical Support Enhancement | Active comparator | Behavioral: Comilia Group, Behavioral: Practical Support EnhancementParticipants receive the Comilia Group intervention plus the Practical Support Enhancement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have a:
- Be providing care for/parenting a child at least 10% of the time who is:
- 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
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comilia GroupParents 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. | Behavioural | Comilia Group Only, Interaction Review Enhancement, Interaction Review Enhancement & Practical Supports Enhancement, Practical Support Enhancement |
| Interaction Review EnhancementParents 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. | Behavioural | Interaction Review Enhancement, Interaction Review Enhancement & Practical Supports Enhancement |
| Practical Support EnhancementParticipants 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. | Behavioural | Interaction Review Enhancement & Practical Supports Enhancement, Practical Support Enhancement |
Primary outcome
Parent responsivity
Time frame: Baseline, 2 months, 4 months and 6 months
Rate-based measure that describes parent responses to child intentional communication acts.
1 secondary outcome
Receptive and expressive vocabulary
Time frame: Baseline, 2 months, 4 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All quantitative experimental data produced during the course of the project will be preserved and shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camille Cioffi principal investigator
Prevention Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comilia Group, Interaction Review Enhancement and Practical Support Enhancement in people with Language Delay and Substance Use Disorders, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie De Anda, PhD, CCC-SLP (541-346-8530, sdeanda@uoregon.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent responsivity (time frame: Baseline, 2 months, 4 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.