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PCIT + Natural Helpers for Childhood Behavior Issues
N/A
Recruiting
Led By Jason Jent, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 weeks
Awards & highlights
Study Summary
This trial will test whether a time-limited intervention involving community health workers can improve outcomes for children and caregivers.
Who is the study for?
This trial is for families with children aged 2-12, specifically targeting those aged 2-7 with a history of abuse or behavior issues and those aged 8-12 at risk for abuse but without significant behavior problems. Participants must not plan to move out of Miami Dade County within six months.Check my eligibility
What is being tested?
The study tests an intervention combining Parent-Child Interaction Therapy (PCIT) with support from community health workers called Natural Helpers (NH), over an 18-week period, aiming to improve engagement, retention in therapy, and outcomes for both child and caregiver.See study design
What are the potential side effects?
As this trial involves behavioral therapy and community support rather than medication, traditional side effects are not applicable. However, participants may experience emotional discomfort or changes in family dynamics during the process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Child externalizing behavior as measured by ECBI Intensity Scale
Child externalizing behavior as measured by ECBI Problem Scale
Family cohesion as measured by Bloom's Family Processes Scale
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Randomized Standard-PCIT groupExperimental Treatment1 Intervention
Participants enrolled in the randomized portion of the study and randomized to receive only Standard PCIT for a maximum of 18 weeks.
Group II: Randomized PCIT plus Natural Helper groupExperimental Treatment2 Interventions
Participants enrolled in the randomized portion of the study and randomized to receive PCIT plus Natural Helper for a maximum of 18 weeks.
Group III: Opt-out Only Standard PCIT groupExperimental Treatment1 Intervention
Participants enrolled in the non-randomized portion of the study and opted in to receive only Standard PCIT for a maximum of 18 weeks.
Group IV: Opt-in PCIT plus Natural Helper groupExperimental Treatment2 Interventions
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.
Find a Location
Who is running the clinical trial?
The Children's Trust, Miami FLOTHER
5 Previous Clinical Trials
2,305 Total Patients Enrolled
1 Trials studying Parenting
1,500 Patients Enrolled for Parenting
University of MiamiLead Sponsor
899 Previous Clinical Trials
409,382 Total Patients Enrolled
2 Trials studying Parenting
1,550 Patients Enrolled for Parenting
The Children's TrustUNKNOWN
4 Previous Clinical Trials
2,205 Total Patients Enrolled
1 Trials studying Parenting
1,500 Patients Enrolled for Parenting
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child, aged 2-12, has a history or risk of abuse but does not show significant behavior issues.My child is either under 2 or over 7 years old and has significant behavior issues.My child is between 2 and 12 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Opt-in PCIT plus Natural Helper group
- Group 2: Randomized Standard-PCIT group
- Group 3: Randomized PCIT plus Natural Helper group
- Group 4: Opt-out Only Standard PCIT group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the study have an age restriction, such that only individuals below 80 can participate?
"This medical trial is seeking participants whose age range falls between the ages of two and twelve."
Answered by AI
Is my eligibility for participation in this clinical trial being considered?
"This clinical trial requires parental permission and limits participants to those aged between 2 and 12. A total of 300 children are being admitted into the study."
Answered by AI
Are there any remaining vacancies for participants in this research protocol?
"Affirmative. The information published on clinicaltrials.gov states that this experiment is still taking participants; it was first posted in December 3rd 2018, and the latest update happened on May 27th 2022. This trial needs 300 patients from 2 distinct medical locations."
Answered by AI
How many participants is the clinical trial accommodating?
"Affirmative. According to clinicaltrials.gov, the trial is actively seeking 300 subjects from 2 centres and was first posted on December 3rd 2018 with its last edit occuring on May 27th 2022."
Answered by AI
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