Caregiver Child Relationship, Child Behavior Problem, Mental Health, Parenting Intervention, Stress
Conditions
Keywords
Attachment and Biobehavioral CatchUp, Parenting Intervention, RISE study, Child behavior, Biomarkers
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.
Interventions
10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
OTHERWaitlist with 4-month delay, then ABC
A 4-month waitlist period, after which they will also receive the home-based ABC program (same as Intervention group).
Sponsors
University of North Carolina, Chapel Hill
University of California, San Francisco
The Duke Endowment
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
RCT with a waitlist control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Parent/Caregiver Inclusion Criteria : * Aged 18 or older * Speaks English or Spanish * Is the parent or legal guardian with legal custody of a child aged between 24 months and 42 months * Is a primary caregiver/parent * Has a home-like environment in which to participate in the intervention Child 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child inflammation | Pre-intervention baseline | Pediatric saliva samples will be assayed for cytokine concentrations. |
| Child epigenetic age acceleration | Pre-intervention baseline | Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age |
| Child telomere length | Pre-intervention baseline | DNA will be extracted from child buccal swabs to calculated T/S ratios. |
| Child hair cortisol | Pre-intervention baseline | Several strands of hair will be collected and assayed to obtain hair cortisol concentration |
| Child stress hormones | Pre-intervention baseline | Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses. |
| Parenting | Pre-intervention baseline | Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment. |
| Child wellbeing | Pre-intervention 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 | Pre-intervention 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 | Pre-intervention 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 | Pre-intervention 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 | Pre-intervention 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. |
Countries
United States
Contacts
CONTACTDanielle Rouvinov, PhD
CONTACTNicole Bush, PhD
PRINCIPAL_INVESTIGATORDanielle Roubinov, PhD
University of North Carolina, Chapel Hill
Outcome results
None listed