Natural Helpers and PCIT

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05400434
Status
Recruiting
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Conditions

  • Child Behavior
  • Parenting

Eligibility Criteria

Sex
ALL
Age
2 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard Parent-Child Interaction Therapy (PCIT) — BEHAVIORAL
    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) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 3, 2018
Status verified
Jan 2026
Primary completion
Dec 27, 2026
Completion
Dec 27, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Child externalizing behavior as measured by ECBI Intensity Scale [ Time Frame: Up to 26 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
ConnectFamiliasMiamiFlorida33136
Betty Alonso
[email protected]
3058542973
Jason Jent, PhD (PRINCIPAL_INVESTIGATOR)
Mailman Center for Child DevelopmentMiamiFlorida33136
Dainelys Garcia, PhD
[email protected]
3052430234
Jason Jent, PhD (PRINCIPAL_INVESTIGATOR)

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ConnectFamilias· Miami, FLMailman Center for Child Development· Miami, FL

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