Resilience Through Interventions for Successful Early Outcomes

Not Applicable

Recruiting

• Conditions: Parenting Intervention; Stress; Caregiver Child Relationship; Child Behavior Problem; Mental Health

• Registration Number: NCT06669624
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

Purpose: The purpose of this research is to determine the effects of Attachment and Biobehavioral Catch-up (ABC), an evidence-based parenting program, on stress biomarkers in children.

Participants: The study will involve approximately 150 caregiver-child dyads, with children aged between 24 and 42 months. Participants will include primary caregivers fluent in English or Spanish, along with their children who have experienced social risk factors for adversity.

Procedures (Methods): Participants will be randomly assigned to either receive the ABC parenting program (10 sessions) immediately or be placed on a wait-list, receiving the program after about 4 months. The study procedures include caregivers completing online surveys, engaging in play-based observational tasks with their children, and collecting non-invasive biological samples (saliva, cheek swab, hair) from the children and saliva samples from the caregivers at 2-3 time-points.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-30
• Status Verified: 2024-11
• Study First Posted: 2024-11-01
• Study Start: 2024-11-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Aged between 24 months and 42 months at enrollment
• Lives with the parent/caregiver at least 50% of the time
• Has experienced social risk factors, including low income, community or family violence, previous trauma/adversity exposure, prolonged separation from caregiver, significant difficulties in relationship with caregiver Child Exclusion Criteria
• 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Parenting	13-20 weeks after baseline	Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.
Child telomere length	13-20 weeks after baseline	DNA will be extracted from child buccal swabs to calculated T/S ratios.
Child hair cortisol	13-20 weeks after baseline	Several strands of hair will be collected and assayed to obtain hair cortisol concentration
Child stress hormones	13-20 weeks after baseline	Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses.
Child inflammation	13-20 weeks after baseline	Pediatric saliva samples will be assayed for cytokine concentrations.
Child epigenetic age acceleration	13-20 weeks after baseline	Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age
Child wellbeing	13-20 weeks after baseline	Caregiver reports of their child's quality of life will be obtained using the Pediatric Quality of Life (PedsQL) Inventory. Scores range from 0 to 100, with higher scores indicating better functioning.
Child executive functioning	13-20 weeks after baseline	Child executive functioning will be assessed using the Minnesota Executive Function Scale™ The MEFS has been nationally normed based on the child's age and standardized scores are automatically generated using an algorithm that combines accuracy and response time (M = 100, SD = 15). Scores range from 60-140, with higher scores indicating better performance.
Child mental health	13-20 weeks after baseline	Child mental health will be assessed using caregiver reports through the Child Behavior Checklist preschool-aged form (1.5-5). We will use the total, internalizing, and externalizing subscales, with scores ranging from 0-200, 0-72, and 0-48, respectively. Higher scores represent worse functioning.
Caregiver anxiety	13-20 weeks after baseline	Caregiver anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. The total score ranges from 0-21, with higher scores indicating more severe anxiety.
Caregiver depression	13-20 weeks after baseline	Caregiver depression symptoms will be assessed using the Patient Health Questionnaire-9 item form. Scores range from 0 to 27, with higher scores representing worse functioning.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, South Carolina, United States