Helping toddlers of caregivers with substance use disorders build language skills with group and individualized parenting supports

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will randomize 244 parent-child pairs into a 2x2 factorial design where everyone receives the Learn and Play Every Day group-based parent-implemented naturalistic communication intervention and some receive additional parental coaching, individualized lessons, both, or neither. The additional coaching and individualized lessons are delivered via telehealth, and randomization is stratified by the parent's primary language (English vs. Spanish). Recruitment occurs through community agencies serving adults with substance use disorders, and interventionists delivering different components are masked to the other components to limit bias. The team will measure child language outcomes, parent responsivity, and other related measures to compare the added benefit of the extra supports.

Why it matters

Who can join: the full rules

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 virtual 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.

Where it's running

• Prevention Science Institute
  Eugene, Oregon, United States Recruiting

Study contacts

• Principal investigator: Camille Cioffi — Prevention Science Institute
• Study coordinator: Stephanie De Anda, PhD, CCC-SLP
• Email: sdeanda@uoregon.edu
• Phone: 541-346-8530

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding late talking in children using brain imaging and behavior assessments

  This study is trying to understand why some toddlers talk later than others by looking at their brains and behaviors to help create better support for them.

  Recruiting at 2 sites University of Toronto · Oshawa, Ontario and 1 other locations · NCT06156865

• Combining oral muscle exercises and bedside reading to help preterm babies feed and build language

  This project tests whether pairing gentle oral muscle exercises with bedside parent reading helps preterm infants (born 23–30 weeks) start oral feeding sooner and improve early language.

  Recruiting Women and Infants Hospital of Rhode Island · Providence, Rhode Island · NCT05861531

• Interprofessional Training to Improve Care for Peri-Delivery Patients with Substance Use Disorder

  This program tests INSPIRE, a set of online and in-person trainings for healthcare teams to reduce stigma and improve care for people with substance use disorder around labor, delivery, and postpartum at the University of Utah.

  Recruiting University of Utah · Salt Lake City, Utah · NCT07707115

• Effects of comorbidity on people with severe mental illness

  This study tests how having both alcohol/substance use and a severe mental illness affects hospitalizations, medications, and social participation among adults followed at a mental health center.

  Recruiting Abant Izzet Baysal University · Bolu, Bolu · NCT07692984

• Interdisciplinary support to smooth care transitions for hospitalized adults with substance use disorders

  This study tests a team-based in-hospital and post-discharge program to help adults with substance use disorders move from hospital care to ongoing community treatment.

  Recruiting University of Utah · Salt Lake City, Utah · NCT07575373

• Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice (MISSION-CJ) for re-entry

  This trial tests a multicomponent program called MISSION-CJ with Peer Linkage Support to help adults released from two Massachusetts jails who have both mental health and substance use disorders.

  Recruiting at 2 sites University of Massachusetts, Worcester · Northampton, Massachusetts and 1 other locations · NCT07555145

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.