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?

This trial aims to support early language development in young children of parents with substance use disorder (SUD). Researchers seek to determine if adding extra support to a group-based parenting program, called the Comilia Group, enhances children's language skills compared to the program alone. The trial will evaluate different combinations of support services, such as interaction reviews and practical support, alongside the main parenting program. Parents who have experienced substance use and are caring for a child aged 12-42 months who isn't yet speaking in full sentences might be a good fit. As an unphased trial, this study offers families a unique opportunity to contribute to research that could enhance parenting programs and support children's language development.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments like those from the Comilia Group have been well-received in past studies. In one study, children made significant progress in language development after a three-month program with therapists, suggesting the program is both effective and safe for children with language delays.

For the Interaction Review Enhancement, studies have found that interactive features in language programs play a crucial role. These methods have successfully improved spoken language in children with language delays, demonstrating they are well-tolerated and carry minimal risk.

Regarding the Practical Support Enhancement, evidence indicates that increasing program intensity can greatly enhance language skills. Specifically, a review found that 96% of children moved closer to their treatment goals within the first five sessions of an enhanced program, suggesting this approach is safe and effective.

Overall, these findings indicate that the interventions in this trial are generally well-tolerated and effective for improving language development in children.12345

Why are researchers excited about this trial?

Researchers are excited about the Comilia Group treatment for speech delay because it combines community support with individualized interventions, which is quite different from traditional speech therapy options. Most standard treatments focus solely on one-on-one therapy sessions with a speech therapist. However, Comilia Group adds a social dimension by integrating group interaction reviews and practical support sessions. This unique approach not only enhances communication skills through peer engagement but also provides tailored support to address specific needs, potentially leading to more comprehensive and effective outcomes for children with speech delays.

What evidence suggests that this trial's treatments could be effective for speech delay?

Research has shown that speech therapy can greatly assist children with speech delays. Studies indicate that with the right support, 50% to 70% of these children can catch up to their peers. In this trial, participants in the Comilia Group Only arm will receive structured language support, which effectively aids in language development. Other participants will receive additional interventions: the Interaction Review Enhancement arm includes sessions that can further improve speaking abilities, while the Practical Support Enhancement arm provides extra resources for families. The Interaction Review Enhancement & Practical Supports Enhancement arm combines both additional interventions. Overall, these methods can significantly enhance children's language skills, helping them overcome delays.678910

Who Is on the Research Team?

CC

Camille Cioffi

Principal Investigator

Prevention Science Institute

Are You a Good Fit for This Trial?

This trial is for caregivers aged 18+ with a history of substance use disorder, who care for a child (12-42 months old) showing early language delays. Caregivers must attend weekly group sessions and speak English or Spanish. Only one caregiver per child can join.

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

Trial Overview

The study compares standard parenting support groups to the same groups plus extra individualized services like enhanced interaction reviews and practical support, to see which better helps young children’s language development.

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+

Citations

Speech and language delay in children: Prevalence and risk ...

Evidence implies that untreated speech and language delay can persist in 40%–60% of the children and these children are at a higher risk of social, emotional, ...

Effectiveness of speech intervention methods in children with ...

Consequences to having a speech delay can be short or long lived and include delays in education, difficulty, or failure to fit in, bullying, and even the ...

Statistics Reinforcing Speech Therapy Effectiveness

Discover key statistics on speech therapy outcomes and the effectiveness of interventions for speech delays.

(PDF) Improving outcomes of preschool language delay in ...

All children received a 1.25-1.5 hour formal language assessment at their 4th birthday. The 200 children with expressive and/or receptive language scores more ...

Prevalence of Speech and Language Delay in Early ...

According to prevalence studies, 7-16% of children are re- ported to have poor language development that cannot be ex- plained by other ...

Prevent Language Delays and Disorders Among Children ...

This study will examine whether adding additional supports to group-based parenting intervention improves child language outcomes compared to ...

The effectiveness of therapist-led family-centered language ...

Both groups demonstrated significant improvements in language development following a 3-month intervention as assessed by the Gesell assessment.

Speech Delay and Hearing Rehabilitation Disparities in ... - PMC

To investigate the influence of race and insurance type on speech delay rates and hearing rehabilitation access in children with bilateral hearing loss (HL).

Communication Outcomes of Children with Hearing Loss

The study found that children in the LSL-SA group had statistically significant better communication outcomes, with 63% achieving age-appropriate speech ...

Collaboration Between Child Play Therapy and Speech ...

Their data support claims that children with poor expressive language skills have difficulty with social interactions and, as a result, may develop a higher ...