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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
-
-
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
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Interaction Review Enhancement & Practical Supports Enhancement
Participants receive the Comilia Group intervention plus the interaction review sessions and practical support sessions.
|
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.
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.
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.
|
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.
|
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.
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.
|
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.
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
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent responsivity
Time Frame: Baseline, 2 months, 4 months and 6 months
|
Rate-based measure that describes parent responses to child intentional communication acts.
|
Baseline, 2 months, 4 months and 6 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Receptive and expressive vocabulary
Time Frame: Baseline, 2 months, 4 months and 6 months
|
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
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Camille Cioffi, Prevention Science Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- STUDY00002032
- R01DC022028 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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