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Child-Adult Relationship Enhancement for Parent-Child Relationships

N/A
Recruiting
Led By Samantha Schilling, MD, MSHP
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child is between 2 and 6 years old
Child has Medicaid/Children's Health Insurance Program (CHIP)/no insurance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 month after baseline (time 3) up to 52 months after baseline (time 5)
Awards & highlights

Study Summary

This trial will test if an intervention can reduce child maltreatment, improve parent-child interactions, reduce harsh/neglectful parenting, and improve stress and child behaviors.

Who is the study for?
This trial is for caregivers over 18 with a child aged 2-6 who live in North Carolina or Philadelphia. The child must have Medicaid/CHIP/no insurance, and the caregiver needs to be able to text and attend virtual sessions. Caregivers can't join if they've done PriCARE/CARIÑO before or if their child is getting other behavioral treatments.Check my eligibility
What is being tested?
PriCARE/CARIÑO program is being tested for its ability to reduce child maltreatment, improve parent-child interactions, lessen harsh parenting practices, decrease parental stress, and mitigate challenging behaviors in children.See study design
What are the potential side effects?
Since this intervention involves educational and support sessions rather than medication, there are no typical medical side effects; however, participants may experience emotional discomfort discussing sensitive topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 2 and 6 years old.
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My child is covered by Medicaid, CHIP, or has no insurance.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 month after baseline (time 3) up to 52 months after baseline (time 5)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 month after baseline (time 3) up to 52 months after baseline (time 5) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Brief Child Abuse Potential Inventory (BCAP) score from time 1 to time 4
Child Protective Services Investigations from time 3 to time 5
Secondary outcome measures
Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Minor Physical Assault score from time 1 to time 4
Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Nonviolent Discipline score from time 1 to time 4
Change in the Conflict Tactics Scales Parent-Child (CTS-PC) Psychological Aggression score from time 1 to time 4
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PriCARE/CARIÑO plus Usual CareExperimental Treatment1 Intervention
Caregiver-child dyads assigned to the PriCARE/CARIÑO plus usual care group will receive the PriCARE/CARIÑO intervention within 4 months of randomization plus usual care. The intervention will last 6 weeks. Each group, administered by 1-2 trained mental health professionals, will have approximately 4-10 caregiver participants and will meet weekly for 6 weeks. Each of the 6 sessions is approximately 80 minutes. Caregivers are expected to practice the skills they learn with their children between sessions.
Group II: Usual careActive Control1 Intervention
Caregiver-child dyads assigned to the usual care group will receive usual care and will not be aware of being in a group of about 8-10 recently-enrolled subjects.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,513 Previous Clinical Trials
4,192,248 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,976 Previous Clinical Trials
2,678,734 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
710 Previous Clinical Trials
8,586,976 Total Patients Enrolled

Media Library

PriCARE/CARIÑO Clinical Trial Eligibility Overview. Trial Name: NCT05233150 — N/A
Parent-Child Relationship Research Study Groups: PriCARE/CARIÑO plus Usual Care, Usual care
Parent-Child Relationship Clinical Trial 2023: PriCARE/CARIÑO Highlights & Side Effects. Trial Name: NCT05233150 — N/A
PriCARE/CARIÑO 2023 Treatment Timeline for Medical Study. Trial Name: NCT05233150 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research grant admittance to individuals aged seventy-five and over?

"This medical experiment is open to those aged 2 or above and below 99 years old."

Answered by AI

What is the purpose of this research endeavor?

"This trial's primary aim is to assess changes in Child Protective Services Investigations over a 6-8 month period. Secondary measures include alterations in the Conflict Tactics Scales Parent-Child (CTS-PC) Minor Physical Assault score, Parenting Scale total score and CTS-PC Weekly Discipline scores across the same timeframe. These metrics are calculated on 0 - 150, 1 - 7 and 0 - 75 scales respectively; higher values indicating worse outcomes for each measure."

Answered by AI

Who meets the criteria for participating in this experiment?

"This clinical study is seeking 1932 parent-child pairs, aged between 2 and 99 years old. To qualify for the trial, a caregiver must be 18 or older, able to verbally communicate in English or Spanish, provide consent forms when requested, attend scheduled meetings during PriCARE/CARIÑO groups sessions. The child of said pair should have Medicaid/Children's Health Insurance Program (CHIP) coverage at participating primary care centers and their legal guardian must own a cellular phone with SMS capabilities as well as access to appropriate technological tools necessary to partake in the virtual intervention."

Answered by AI

Does this experiment still accept participants?

"Affirmative. Clinicaltrials.gov records show that this medical study, originally posted on May 18th 2022, is still in need of recruitment. 1932 patients have to be accepted from 2 different sites for the trial to continue."

Answered by AI

How many participants are being inducted into this medical experiment?

"Affirmative. The information posted on clinicaltrials.gov declares that this medical study, which was first published on May 18th 2022, is currently recruiting participants. 1932 subjects have to be recruited from 2 different research centres."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)
2022. "Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05233150.
~854 spots leftby Jan 2026
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