Natural Helpers and PCIT
- Conditions
- ParentingChild Behavior
- Interventions
- Behavioral: Standard Parent-Child Interaction Therapy (PCIT)Behavioral: Natural Helpers (NH)
- Registration Number
- NCT05400434
- Lead Sponsor
- University of Miami
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Opt-in PCIT plus Natural Helper group Natural Helpers (NH) 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. Randomized Standard-PCIT group Standard Parent-Child Interaction Therapy (PCIT) Participants enrolled in the randomized portion of the study and randomized to receive only Standard PCIT for a maximum of 18 weeks. Randomized PCIT plus Natural Helper group Standard Parent-Child Interaction Therapy (PCIT) Participants enrolled in the randomized portion of the study and randomized to receive PCIT plus Natural Helper for a maximum of 18 weeks. Opt-out Only Standard PCIT group Standard Parent-Child Interaction Therapy (PCIT) Participants enrolled in the non-randomized portion of the study and opted in to receive only Standard PCIT for a maximum of 18 weeks. Randomized PCIT plus Natural Helper group Natural Helpers (NH) Participants enrolled in the randomized portion of the study and randomized to receive PCIT plus Natural Helper for a maximum of 18 weeks. Opt-in PCIT plus Natural Helper group Standard Parent-Child Interaction Therapy (PCIT) 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 Measures
Name Time Method Parenting Stress as measured by Parenting Stress Index Short Form (PSI-SF-4) Up to 26 weeks 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.
Child externalizing behavior as measured by ECBI Intensity Scale Up to 26 weeks 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.
Family cohesion as measured by Bloom's Family Processes Scale Up to 26 weeks 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.
Child externalizing behavior as measured by ECBI Problem Scale Up to 26 weeks 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) Up to 26 weeks 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.
Family conflict as measured by Bloom's Family Processes Scale Up to 26 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
ConnectFamilias
🇺🇸Miami, Florida, United States
Mailman Center for Child Development
🇺🇸Miami, Florida, United States