Clinical trial Recruiting at 2 sites Interventional Ages 2 to 12

Community health worker intervention for child behavior and parenting support

Official title: The Development and Implementation of a Natural Helpers Program to Increase the Recruitment, Retention, and Engagement of Underserved Families in Parent-Child Interaction Therapy (PCIT)

Run by University of Miami · NCT05400434 · Data updated 2026-11-12

This study is testing a new program that helps families with children aged 2 to 12 who have behavior problems or have experienced abuse by combining therapy with support from community health workers to see if it improves their situation.

Quick facts

Study typeInterventional
Ages2 Years to 12 Years
SexAll
Enrollment300 (estimated)
SponsorUniversity of Miami
Academic / other
Locations2 sites (Miami, Florida and 1 other locations)
StatusRecruiting
StartedDecember 3, 2018
Main results expectedDecember 27, 2026
Study endsDecember 27, 2026
Registry record updatedJanuary 13, 2026
Trial IDNCT05400434 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include families with children aged 2 to 12 who have a history of child abuse or behavior problems.

Probably not a fit

Patients who have children younger than 2 years or older than 7 years with clinically significant behavior problems may not benefit from this study.

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

What this trial studies

This study evaluates the effectiveness of an 18-week intervention combining Parent-Child Interaction Therapy (PCIT) with a natural helper model, aimed at improving treatment engagement and outcomes for children and caregivers. The intervention targets families with children aged 2 to 12 who have experienced abuse or exhibit behavior problems. Community health workers will facilitate the sessions to enhance support and retention in the program. The study is conducted in Miami, Florida, focusing on addressing mental health disparities in the community.

Why it matters

Potential benefit: If successful, this intervention could significantly improve child behavior and parenting skills, leading to better family dynamics and child well-being.

How similar studies have gone: Other studies have shown success with community health worker interventions in improving mental health outcomes, suggesting a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Families of children 2 years of age to 12 years of age.
2. Children 2 to 7 years of age with a history of child abuse or neglect and/or child behavior problems or children ages 8 years to 12 years of age with history of or risk for abuse and the child does not exhibit clinically significant behavior problems.
3. At the time of enrollment, participants must agree that, within the upcoming six months, they will not move away to a location where they would no longer be able to regularly attend weekly sessions (i.e., moving out of Miami Dade County).

Exclusion Criteria:

1. Families with child younger than 2 years of age or older than 7 years of age with clinically significant behavior problems
2. Adults who are unable to consent and prisoners

Where it's running

  • ConnectFamilias
    Miami, Florida, United States
    Recruiting
  • Mailman Center for Child Development
    Miami, Florida, United States
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.