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Behavioral Intervention
Parenting Program for Stress in Children (RISE Trial)
N/A
Recruiting
Led By Danielle Roubinov, PhD
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: Aged between 24 months and 42 months at enrollment
Parent/Caregiver: Aged 18 or older
Must not have
Child: Has a diagnosed genetic or congenital disorders, including but not limited to Down syndrome, cerebral palsy, seizure disorders, endocrine disorders (or is using steroid medications, including human growth hormone), or was born with birth defects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13-20 weeks after baseline
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see how a parenting program called Attachment and Biobehavioral Catch-up (ABC) affects stress levels in children. About 150 caregiver-child pairs will participate, with children between
Who is the study for?
This trial is for caregiver-child pairs where the child is aged 24-54 months and has faced social challenges. Caregivers must speak English or Spanish. The study excludes those who don't meet these language and age requirements, or cannot commit to the study timeline.
What is being tested?
The trial tests a parenting program called Attachment and Biobehavioral Catch-up (ABC) on children's stress markers. Half of participants start ABC immediately, while the other half wait for about 4 months before beginning. It involves surveys, play tasks, and collecting biological samples.
What are the potential side effects?
Since this intervention is non-medical involving parenting sessions, there are no direct physical side effects like with drugs; however, participating in research can sometimes cause temporary discomfort or stress.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 2 and 3.5 years old.
Select...
I am a parent or caregiver and I am 18 years old or older.
Select...
I am the legal guardian of a child aged 2 to 3.5 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My child has a condition like Down syndrome, cerebral palsy, or was born with birth defects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-intervention baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-intervention baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Caregiver anxiety
Caregiver depression
Child epigenetic age acceleration
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Waitlist-Control (ABC after delay)Experimental Treatment2 Interventions
Participants will be placed on a four-month waitlist and then receive ABC in the same manner as the Experimental Group
Group II: ABC Program - no waitExperimental Treatment1 Intervention
Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Attachment and Biobehavioral Catch-up (ABC)
2018
N/A
~10
Find a Location
Who is running the clinical trial?
The Duke EndowmentOTHER
15 Previous Clinical Trials
47,896 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,557 Total Patients Enrolled
University of California, San FranciscoOTHER
2,593 Previous Clinical Trials
14,887,800 Total Patients Enrolled
5 Trials studying Mental Health
2,061 Patients Enrolled for Mental Health
Danielle Roubinov, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
3 Previous Clinical Trials
1,783 Total Patients Enrolled