An interventional study of Standard Parent-Child Interaction Therapy (PCIT) and Natural Helpers (NH) in Child Behavior and Parenting, sponsored by University of Miami. Recruiting at 2 sites in United States. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.
This study's planned enrollment of 300 is above the median of 140 across 197 interventional studies indexed under Child Behavior.
Browse Child Behavior studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants enrolled in the randomized portion of the study and randomized to receive only Standard PCIT for a maximum of 18 weeks.
Behavioral: 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.
Behavioral: Standard Parent-Child Interaction Therapy (PCIT) · Behavioral: Natural Helpers (NH)
Participants enrolled in the non-randomized portion of the study and opted in to receive only Standard PCIT for a maximum of 18 weeks.
Behavioral: 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.
Behavioral: Standard Parent-Child Interaction Therapy (PCIT) · Behavioral: Natural Helpers (NH)
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 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.
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.
Time frame: Up to 26 weeks
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.
Time frame: Up to 26 weeks
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.
Time frame: Up to 26 weeks
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.
Time frame: Up to 26 weeks
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.
Time frame: Up to 26 weeks
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.
Time frame: Up to 26 weeks
Plan to share: No
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Started Dec 2018 (actual). Primary completion is estimated for Dec 2026, 96 months after the start.
Of 140 non-industry interventional studies with no phase under Child Behavior, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 96 months is above that.
Counting every sponsor, half of 141 studies reached it within 20 months; a quarter within 8 and three quarters within 41.
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