Recruiting

Natural Helpers & PCIT

Sponsor:

University of Miami

Code:

NCT05400434

Conditions

Child Behavior

Parenting

Eligibility Criteria

Sex: All

Age: 2 - 12

Healthy Volunteers: Not accepted

Interventions

Standard Parent-Child Interaction Therapy (PCIT)

Natural Helpers (NH)

Study Details

Brief summary:

The purpose of the study is to evaluate the effect of a time-limited (i.e., 18 weeks) community health worker (CHW) intervention, referred to as the Parent Child Interaction Therapy (PCIT) plus natural helper (NH) model, on treatment engagement, retention, and child and caregiver outcomes.

Conditions

Child Behavior

Parenting

Study ID

NCT05400434

Start date

Dec 3, 2018

Status verified date

Jan, 2026

Completion date

Dec 27, 2026

Anticipated

Primary completion date

Dec 27, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Randomized Standard-PCIT group

Participants enrolled in the randomized portion of the study and randomized to receive only Standard PCIT for a maximum of 18 weeks.

experimental: Randomized PCIT plus Natural Helper group

Participants enrolled in the randomized portion of the study and randomized to receive PCIT plus Natural Helper for a maximum of 18 weeks.

experimental: Opt-out Only Standard PCIT group

Participants enrolled in the non-randomized portion of the study and opted in to receive only Standard PCIT for a maximum of 18 weeks.

experimental: Opt-in PCIT plus Natural Helper group

Participants enrolled in the non-randomized portion of the study and opted in to receive PCIT plus Natural Helper for a maximum of 18 weeks.

Interventions

Standard Parent-Child Interaction Therapy (PCIT)

PCIT is an evidence-based behavioral parenting intervention. It is administered as weekly, one-hour sessions with a bilingual PCIT therapist for 18 weeks in one of three PCIT clinics embedded within neighborhood community agencies or virtually.

Natural Helpers (NH)

Natural helpers are lay people to whom others naturally turn for advice, emotional support, and tangible aid. Families received weekly sessions with a natural helpers in their home or virtually for 30-45 minutes for a maximum of 18 weeks. During sessions, natural helpers work with families to (1) explain parenting principles in a culturally and responsive manner; (2) support them in their skill acquisition; and (3) troubleshoot structural barriers to service and other basic life needs.

Primary outcome measure

  • Child externalizing behavior as measured by ECBI Intensity Scale [ Time Frame: Up to 26 weeks ]
  • Child externalizing behavior as measured by ECBI Problem Scale [ Time Frame: Up to 26 weeks ]
  • Parenting Skills as measured by the Dyadic Parent-Child Interaction Coding System (DPICS-IV) [ Time Frame: Up to 26 weeks ]
  • Parenting Stress as measured by Parenting Stress Index Short Form (PSI-SF-4) [ Time Frame: Up to 26 weeks ]
  • Family conflict as measured by Bloom's Family Processes Scale [ Time Frame: Up to 26 weeks ]
  • Family cohesion as measured by Bloom's Family Processes Scale [ Time Frame: Up to 26 weeks ]

Central Contacts and Locations

Central contacts

Dainelys Garcia, PhD

3052430234ngarcia09@med.miami.edu

Natalie Espinosa, PsyD

3052430234nae30@med.miami.edu

Locations

ConnectFamilias

Recruiting

Miami, Florida, United States, 33136

Contacts

Betty Alonso

3058542973betty@connectfamilias.org

Principal Investigator:

Jason Jent, PhD

Mailman Center for Child Development

Recruiting

Miami, Florida, United States, 33136

Contacts

Dainelys Garcia, PhD

3052430234ngarcia09@med.miami.edu

Principal Investigator:

Jason Jent, PhD

More Information

Sponsor

University of Miami

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

  • Community Health Workers
  • Mental Health Disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-01-13.