Resilience Through Interventions for Successful Early Outcomes (RISE)

Leveraging Scientific Advances to Strengthen the Implementation, Evaluation, and Impacts of Intervention Programs for Children Experiencing Early Life Adversity

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Child Behavior Problem; Mental Health; Parenting Intervention; Caregiver Child Relationship
• Intervention / Treatment: Behavioral: Attachment and Biobehavioral Catch-up (ABC); Other: Waitlist with 4-month delay, then ABC

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Rouvinov, PhD; Phone Number: 919-843-5898; Email: roubinov@email.unc.edu
• Study Contact Backup: Name: Nicole Bush, PhD; Phone Number: 415-476-7655; Email: Nicole.Bush@ucsf.edu

Study Locations

• United States
  • South Carolina
    • Chapel Hill, South Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Natalie O'Brien; Phone Number: 919-966-0421; Email: natalie_obrien@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABC Program - no wait; Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance.	Behavioral: Attachment and Biobehavioral Catch-up (ABC); 10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
Other: Waitlist-Control (ABC after delay); 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); 10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.; Other: Waitlist 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child inflammation	Pediatric saliva samples will be assayed for cytokine concentrations.	Pre-intervention baseline
Child inflammation	Pediatric saliva samples will be assayed for cytokine concentrations.	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	Pre-intervention baseline
Child epigenetic age acceleration	Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age	13-20 weeks after baseline
Child telomere length	DNA will be extracted from child buccal swabs to calculated T/S ratios.	Pre-intervention baseline
Child telomere length	DNA will be extracted from child buccal swabs to calculated T/S ratios.	13-20 weeks after baseline
Child hair cortisol	Several strands of hair will be collected and assayed to obtain hair cortisol concentration	Pre-intervention baseline
Child hair cortisol	Several strands of hair will be collected and assayed to obtain hair cortisol concentration	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.	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.	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.	Pre-intervention baseline
Parenting	Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	13-20 weeks after baseline

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: University of California, San Francisco; The Duke Endowment
• Investigators: Principal Investigator: Danielle Roubinov, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Dozier M, Peloso E, Lewis E, Laurenceau JP, Levine S. Effects of an attachment-based intervention on the cortisol production of infants and toddlers in foster care. Dev Psychopathol. 2008 Summer;20(3):845-59. doi: 10.1017/S0954579408000400.
• McEwen LM, O'Donnell KJ, McGill MG, Edgar RD, Jones MJ, MacIsaac JL, Lin DTS, Ramadori K, Morin A, Gladish N, Garg E, Unternaehrer E, Pokhvisneva I, Karnani N, Kee MZL, Klengel T, Adler NE, Barr RG, Letourneau N, Giesbrecht GF, Reynolds JN, Czamara D, Armstrong JM, Essex MJ, de Weerth C, Beijers R, Tollenaar MS, Bradley B, Jovanovic T, Ressler KJ, Steiner M, Entringer S, Wadhwa PD, Buss C, Bush NR, Binder EB, Boyce WT, Meaney MJ, Horvath S, Kobor MS. The PedBE clock accurately estimates DNA methylation age in pediatric buccal cells. Proc Natl Acad Sci U S A. 2020 Sep 22;117(38):23329-23335. doi: 10.1073/pnas.1820843116. Epub 2019 Oct 14.
• Sullivan ADW, Roubinov D, Norona-Zhou AN, Bush NR. Do dyadic interventions impact biomarkers of child health? A state-of-the-science narrative review. Psychoneuroendocrinology. 2024 Apr;162:106949. doi: 10.1016/j.psyneuen.2023.106949. Epub 2023 Dec 27.
• Shonkoff JP, Boyce WT, Bush NR, Gunnar MR, Hensch TK, Levitt P, Meaney MJ, Nelson CA, Slopen N, Williams DR, Silveira PP. Translating the Biology of Adversity and Resilience Into New Measures for Pediatric Practice. Pediatrics. 2022 Jun 1;149(6):e2021054493. doi: 10.1542/peds.2021-054493.
• Dozier, M., Bernard, K., Roben, C. K., Steele, H., & Steele, M. (2017). Attachment and biobehavioral catch-up. Handbook of attachment-based interventions, 27-49.
• de Mendonca Filho EJ, Pokhvisneva I, Maalouf CM, Parent C, Mliner SB, Slopen N, Williams DR, Bush NR, Boyce WT, Levitt P, Nelson CA, Gunnar MR, Meaney MJ, Shonkoff JP, Silveira PP; JPB Research Network on Toxic Stress. Linking specific biological signatures to different childhood adversities: findings from the HERO project. Pediatr Res. 2023 Aug;94(2):564-574. doi: 10.1038/s41390-022-02415-y. Epub 2023 Jan 17.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Biomarkers; Child behavior; Parenting Intervention; Attachment and Biobehavioral CatchUp; RISE study
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being; Child Behavior; Organization and Administration; Health Services Administration; Appointments and Schedules; Waiting Lists
• Other Study ID Numbers: 24-0889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results, as well as derived data supporting the results.
• IPD Sharing Time Frame: beginning 9 to 36 months following publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No