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Natural Helpers and PCIT

Primary Purpose

Child Behavior, Parenting

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Parent-Child Interaction Therapy (PCIT)
Natural Helpers (NH)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Behavior focused on measuring Community Health Workers, Mental Health Disparities

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • ConnectFamiliasRecruiting
  • Mailman Center for Child DevelopmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Randomized Standard-PCIT group

Randomized PCIT plus Natural Helper group

Opt-out Only Standard PCIT group

Opt-in PCIT plus Natural Helper group

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

Child externalizing behavior as measured by ECBI Intensity Scale
The Eyberg Child Behavior Inventory (ECBI) is a 36-item caregiver report measure of disruptive behaviors in children ages 2-16 . The Intensity Scale assesses the frequency of behavior problems (1=never to 7=always) with total scores ranging from 36 to 252. A raw score of 131 or higher on the Intensity Scale is considered clinically significant child externalizing behavior.
Child externalizing behavior as measured by ECBI Problem Scale
The Eyberg Child Behavior Inventory (ECBI) is a 36-item caregiver report measure of disruptive behaviors in children ages 2-16 . The Problem Scale assesses caregiver perceived behavior problems (1 = yes, 0 = no) with total scores ranging from 0 to 36. A raw score of 15 or higher on the Problem Scale is considered clinically significant child externalizing behavior.
Parenting Skills as measured by the Dyadic Parent-Child Interaction Coding System (DPICS-IV)
The DPICS-IV is a behavioral observation tool used to code and assess caregiver behaviors and the quality of caregiver and child interactions. PCIT therapists code the three 5-minute DPICS-IV observations: (1) child-led play (CLP), (2) parent-led play (PLP), and (3) clean-up (CU). The number of positive parenting practices (e.g., labeled praises, reflections, and behavior descriptions) and negative parenting practices are tallied (e.g., questions, commands, and criticisms) are coded during CLP observations. During PLP and CU observations, caregiver verbalizations were coded to generate rates of: (1) caregiver effective commands, (2) caregiver correct follow-through on effective commands, and (3) child compliance to effective commands. The higher the score the higher the parenting behavior and child compliance.
Parenting Stress as measured by Parenting Stress Index Short Form (PSI-SF-4)
The PSI-SF-4 is a 36-item self-report questionnaire used to measure caregiver stress and difficulties in the caregiver-child relationship for caregivers of youth between ages 0-12. The PSI-SF-4 yields a Total Stress percentile score (0-100) with higher scores indicating higher stress.
Family conflict as measured by Bloom's Family Processes Scale
The Bloom's Family Processes Scale assesses family conflict and cohesion using a 5-item conflict subscale (e.g. "we fight a lot in our family"). Caregivers rate their level of agreement on a five-point Likert scale (1=strongly agree to 5=strongly disagree). Total score ranges from 5-25 with the higher scores indicating greater conflict.
Family cohesion as measured by Bloom's Family Processes Scale
The Bloom's Family Processes Scale assesses family cohesion using a 5-item cohesion subscale (e.g., "there is a feeling of togetherness in our family"). Caregivers rate their level of agreement on a five-point Likert scale (1=strongly agree to 5=strongly disagree). Total score ranges from 5-25 with the higher scores indicating greater cohesion.

Secondary Outcome Measures

Full Information

First Posted
May 27, 2022
Last Updated
April 20, 2023
Sponsor
University of Miami
Collaborators
The Children's Trust, Miami FL, ConnectFamilias
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1. Study Identification

Unique Protocol Identification Number
NCT05400434
Brief Title
Natural Helpers and PCIT
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
May 27, 2024 (Anticipated)
Study Completion Date
May 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
The Children's Trust, Miami FL, ConnectFamilias

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior, Parenting
Keywords
Community Health Workers, Mental Health Disparities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The trial was originally designed as a parallel randomized trial. Due to the coronavirus pandemic, the study has been amended to a non-randomized trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Randomized Standard-PCIT group
Arm Type
Experimental
Arm Description
Participants enrolled in the randomized portion of the study and randomized to receive only Standard PCIT for a maximum of 18 weeks.
Arm Title
Randomized PCIT plus Natural Helper group
Arm Type
Experimental
Arm Description
Participants enrolled in the randomized portion of the study and randomized to receive PCIT plus Natural Helper for a maximum of 18 weeks.
Arm Title
Opt-out Only Standard PCIT group
Arm Type
Experimental
Arm 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.
Arm Title
Opt-in PCIT plus Natural Helper group
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Parent-Child Interaction Therapy (PCIT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Natural Helpers (NH)
Intervention Description
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 Information:
Title
Child externalizing behavior as measured by ECBI Intensity Scale
Description
The Eyberg Child Behavior Inventory (ECBI) is a 36-item caregiver report measure of disruptive behaviors in children ages 2-16 . The Intensity Scale assesses the frequency of behavior problems (1=never to 7=always) with total scores ranging from 36 to 252. A raw score of 131 or higher on the Intensity Scale is considered clinically significant child externalizing behavior.
Time Frame
Up to 26 weeks
Title
Child externalizing behavior as measured by ECBI Problem Scale
Description
The Eyberg Child Behavior Inventory (ECBI) is a 36-item caregiver report measure of disruptive behaviors in children ages 2-16 . The Problem Scale assesses caregiver perceived behavior problems (1 = yes, 0 = no) with total scores ranging from 0 to 36. A raw score of 15 or higher on the Problem Scale is considered clinically significant child externalizing behavior.
Time Frame
Up to 26 weeks
Title
Parenting Skills as measured by the Dyadic Parent-Child Interaction Coding System (DPICS-IV)
Description
The DPICS-IV is a behavioral observation tool used to code and assess caregiver behaviors and the quality of caregiver and child interactions. PCIT therapists code the three 5-minute DPICS-IV observations: (1) child-led play (CLP), (2) parent-led play (PLP), and (3) clean-up (CU). The number of positive parenting practices (e.g., labeled praises, reflections, and behavior descriptions) and negative parenting practices are tallied (e.g., questions, commands, and criticisms) are coded during CLP observations. During PLP and CU observations, caregiver verbalizations were coded to generate rates of: (1) caregiver effective commands, (2) caregiver correct follow-through on effective commands, and (3) child compliance to effective commands. The higher the score the higher the parenting behavior and child compliance.
Time Frame
Up to 26 weeks
Title
Parenting Stress as measured by Parenting Stress Index Short Form (PSI-SF-4)
Description
The PSI-SF-4 is a 36-item self-report questionnaire used to measure caregiver stress and difficulties in the caregiver-child relationship for caregivers of youth between ages 0-12. The PSI-SF-4 yields a Total Stress percentile score (0-100) with higher scores indicating higher stress.
Time Frame
Up to 26 weeks
Title
Family conflict as measured by Bloom's Family Processes Scale
Description
The Bloom's Family Processes Scale assesses family conflict and cohesion using a 5-item conflict subscale (e.g. "we fight a lot in our family"). Caregivers rate their level of agreement on a five-point Likert scale (1=strongly agree to 5=strongly disagree). Total score ranges from 5-25 with the higher scores indicating greater conflict.
Time Frame
Up to 26 weeks
Title
Family cohesion as measured by Bloom's Family Processes Scale
Description
The Bloom's Family Processes Scale assesses family cohesion using a 5-item cohesion subscale (e.g., "there is a feeling of togetherness in our family"). Caregivers rate their level of agreement on a five-point Likert scale (1=strongly agree to 5=strongly disagree). Total score ranges from 5-25 with the higher scores indicating greater cohesion.
Time Frame
Up to 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Families of children 2 years of age to 12 years of age. 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. 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: Families with child younger than 2 years of age or older than 7 years of age with clinically significant behavior problems Adults who are unable to consent and prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dainelys Garcia, PhD
Phone
3052430234
Email
ngarcia09@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie Espinosa, PsyD
Phone
3052430234
Email
nae30@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Jent, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
ConnectFamilias
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Betty Alonso
Phone
305-854-2973
Email
betty@connectfamilias.org
First Name & Middle Initial & Last Name & Degree
Jason Jent, PhD
Facility Name
Mailman Center for Child Development
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dainelys Garcia, PhD
Phone
305-243-0234
Email
ngarcia09@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Jason Jent, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Natural Helpers and PCIT

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