Natural Helpers and PCIT

University of Miami

Status: Enrolling

Conditions: Parenting; Child Behavior

Treatments: Behavioral: Natural Helpers (NH); Behavioral: Standard Parent-Child Interaction Therapy (PCIT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05400434

20140839

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Randomized Standard-PCIT group

Experimental group

Description:

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

Treatment:

Behavioral: Standard Parent-Child Interaction Therapy (PCIT)

Randomized PCIT plus Natural Helper group

Experimental group

Description:

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

Treatment:

Behavioral: Standard Parent-Child Interaction Therapy (PCIT)

Behavioral: Natural Helpers (NH)

Opt-out Only Standard PCIT group

Experimental group

Description:

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

Treatment:

Behavioral: Standard Parent-Child Interaction Therapy (PCIT)

Opt-in PCIT plus Natural Helper group

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Parent-Child Interaction Therapy (PCIT)

Behavioral: Natural Helpers (NH)