244 Participants NeededMy employer runs this trial

Community Groups + Individualized Services for Speech Delay

SD
MC
Overseen ByMaya Casper
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Oregon
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

CC

Camille Cioffi

Principal Investigator

Prevention Science Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

I am willing to attend weekly group sessions for six weeks.
Be able to provide consent for their target child to participate, or have a legal guardian provide consent for the child to participate
I am willing to attend Zoom meetings if required.
See 4 more

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the group-based intervention and are randomized to additional intervention modalities such as parental coaching and individualized lessons

2 months
Telehealth sessions

Follow-up

Participants are monitored for changes in parent responsivity and child language outcomes

6 months
Assessments at 2, 4, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Comilia Group
  • Interaction Review Enhancement
  • Practical Support Enhancement

How Is the Trial Designed?

4

Treatment groups

Active Control

Group I: Interaction Review Enhancement & Practical Supports EnhancementActive Control3 Interventions
Group II: Comilia Group OnlyActive Control1 Intervention
Group III: Interaction Review EnhancementActive Control2 Interventions
Group IV: Practical Support EnhancementActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oregon

Lead Sponsor

Trials
91
Recruited
46,700+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+