Resilience Through Interventions for Successful Early Outcomes
NCT ID: NCT06669624
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-11-12
2027-08-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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ABC Program - no wait
Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance.
Attachment and Biobehavioral Catch-up (ABC)
10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
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
Attachment and Biobehavioral Catch-up (ABC)
10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
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).
Interventions
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Attachment and Biobehavioral Catch-up (ABC)
10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
The Duke Endowment
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Danielle Roubinov, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Natalie O'Brien
Role: primary
References
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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, 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.
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.
Other Identifiers
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24-0889
Identifier Type: -
Identifier Source: org_study_id