Menu
Recruiting NCT06669624

Resilience Through Interventions for Successful Early Outcomes

No phase Interventional Parenting Intervention Stress Caregiver Child Relationship Child Behavior Problem

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Attachment and Biobehavioral Catch-up (ABC), Waitlist with 4-month delay, then ABC.
Who it may be relevant to
Registry conditions: Parenting Intervention, Stress, Caregiver Child Relationship, Child Behavior Problem. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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).

Primary outcome measures

  • Child inflammation [Time frame: Pre-intervention baseline]
  • Child inflammation [Time frame: 13-20 weeks after baseline]
  • Child epigenetic age acceleration [Time frame: Pre-intervention baseline]
  • Child epigenetic age acceleration [Time frame: 13-20 weeks after baseline]
  • Child telomere length [Time frame: Pre-intervention baseline]
  • Child telomere length [Time frame: 13-20 weeks after baseline]
  • Child hair cortisol [Time frame: Pre-intervention baseline]
  • Child hair cortisol [Time frame: 13-20 weeks after baseline]
  • Child stress hormones [Time frame: Pre-intervention baseline]
  • Child stress hormones [Time frame: 13-20 weeks after baseline]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of North Carolina at Chapel Hill — Chapel Hill

Publications

  • 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 PMID 31611402
  • 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
  • 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
  • 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
  • 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 PMID 36650307

Identifiers

NCT: NCT06669624 · 24-0889

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗