An interventional study of Attachment and Biobehavioral Catch-up (ABC) and Waitlist with 4-month delay, then ABC in Parenting Intervention, Stress and Caregiver Child Relationship, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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.
224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.
This study's planned enrollment of 150 is close to the median of 140 across 197 interventional studies indexed under Child Behavior.
Browse Child Behavior studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Compared within Child Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychological Well-Being. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Parent/Caregiver Inclusion Criteria :
Child Inclusion 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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance.
Behavioral: Attachment and Biobehavioral Catch-up (ABC)
Participants will be placed on a four-month waitlist and then receive ABC in the same manner as the Experimental Group
Behavioral: Attachment and Biobehavioral Catch-up (ABC) · Other: Waitlist with 4-month delay, then ABC
10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
A 4-month waitlist period, after which they will also receive the home-based ABC program (same as Intervention group).
Child inflammation
Pediatric saliva samples will be assayed for cytokine concentrations.
Time frame: Pre-intervention baseline
Child inflammation
Pediatric saliva samples will be assayed for cytokine concentrations.
Time frame: 13-20 weeks after baseline
Child epigenetic age acceleration
Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age
Time frame: Pre-intervention baseline
Child epigenetic age acceleration
Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age
Time frame: 13-20 weeks after baseline
Child telomere length
DNA will be extracted from child buccal swabs to calculated T/S ratios.
Time frame: Pre-intervention baseline
Child telomere length
DNA will be extracted from child buccal swabs to calculated T/S ratios.
Time frame: 13-20 weeks after baseline
Child hair cortisol
Several strands of hair will be collected and assayed to obtain hair cortisol concentration
Time frame: Pre-intervention baseline
Child hair cortisol
Several strands of hair will be collected and assayed to obtain hair cortisol concentration
Time frame: 13-20 weeks after baseline
Child stress hormones
Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses.
Time frame: Pre-intervention baseline
Child stress hormones
Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses.
Time frame: 13-20 weeks after baseline
Parenting
Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.
Time frame: Pre-intervention baseline
Parenting
Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.
Time frame: 13-20 weeks after baseline
Child wellbeing
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.
Time frame: Pre-intervention baseline
Child wellbeing
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.
Time frame: 13-20 weeks after baseline
Child executive functioning
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.
Time frame: Pre-intervention baseline
Child executive functioning
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.
Time frame: 13-20 weeks after baseline
Child mental health
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.
Time frame: Pre-intervention baseline
Child mental health
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.
Time frame: 13-20 weeks after baseline
Caregiver anxiety
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.
Time frame: Pre-intervention baseline
Caregiver anxiety
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.
Time frame: 13-20 weeks after baseline
Caregiver depression
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.
Time frame: Pre-intervention baseline
Caregiver depression
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.
Time frame: 13-20 weeks after baseline
Plan to share: Yes — Deidentified individual data that supports the results, as well as derived data supporting the results.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: beginning 9 to 36 months following publication
Access criteria: Investigators who propose to use the data and have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.
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