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Recruiting Not applicable NCT07529327

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

No applicable phase (e.g. observational)
Conditions: Language Delay Substance Use Disorders Language Disorders in Children Language Development Prevention Intervention

Sponsor: University of Oregon

trial.available_in: БГ
Overview
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.
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
Who can participate
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.
Interventions
Comilia Group
BEHAVIORAL
Interaction Review Enhancement
BEHAVIORAL
Practical Support Enhancement
BEHAVIORAL
Locations 1
United States (1)
Prevention Science Institute
Eugene , Oregon
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
10.03.2026
Completion date
30.11.2029
Registry ID
NCT07529327
Source
clinicaltrials.gov
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