Resilience Through Interventions for Successful Early Outcomes

NCT06669624 | Recruiting

• 1 other identifier: 24-0889
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting Intervention; Stress; Child Behavior Problem; Mental Health; Caregiver Child Relationship

Keywords

Attachment and Biobehavioral CatchUp; Parenting Intervention; RISE study; Child behavior; Biomarkers

Outcome Measures

Primary Outcomes (22)

• 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

Study Arms (2)

ABC Program - no wait

EXPERIMENTAL

Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance.

Behavioral: Attachment and Biobehavioral Catch-up (ABC)

Waitlist-Control (ABC after delay)

OTHER

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

Interventions

Waitlist with 4-month delay, then ABC OTHER

A 4-month waitlist period, after which they will also receive the home-based ABC program (same as Intervention group).

Waitlist-Control (ABC after delay)

Attachment and Biobehavioral Catch-up (ABC) BEHAVIORAL

10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.

ABC Program - no wait; Waitlist-Control (ABC after delay)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Aged between 24 months and 42 months at enrollment
• Lives with the parent/caregiver at least 50% of the time

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: collaborator
• The Duke Endowment: collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, South Carolina, 27599, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 31611402 BACKGROUND

• 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.

  PMID: 38295654 BACKGROUND

• 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.

  PMID: 35535547 BACKGROUND

• 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.

  PMID: 18606034 BACKGROUND

• Dozier, M., Bernard, K., Roben, C. K., Steele, H., & Steele, M. (2017). Attachment and biobehavioral catch-up. Handbook of attachment-based interventions, 27-49.

  BACKGROUND

• 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.

  PMID: 36650307 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Child Behavior

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Danielle Roubinov, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Rouvinov, PhD

CONTACT

919-843-5898; roubinov@email.unc.edu

Nicole Bush, PhD

CONTACT

415-476-7655; Nicole.Bush@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT with a waitlist control group

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

US (1)