Clinical trial NCT06669624: Resilience Through Interventions for Successful Early Outcomes
Official title: Leveraging Scientific Advances to Strengthen the Implementation, Evaluation, and Impacts of Intervention Programs for Children Experiencing Early Life Adversity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parenting Intervention
Stress
Caregiver Child Relationship
Child Behavior Problem
Mental Health
Keywords: Attachment and Biobehavioral CatchUp
Parenting Intervention
RISE study
Child behavior
Biomarkers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: The Duke Endowment
First posted: 2024-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT with a waitlist control group
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Child inflammation
timeFrame: Pre-intervention baseline
measure: Child inflammation
timeFrame: 13-20 weeks after baseline
measure: Child epigenetic age acceleration
timeFrame: Pre-intervention baseline
measure: Child epigenetic age acceleration
timeFrame: 13-20 weeks after baseline
measure: Child telomere length
timeFrame: Pre-intervention baseline
measure: Child telomere length
timeFrame: 13-20 weeks after baseline
measure: Child hair cortisol
timeFrame: Pre-intervention baseline
measure: Child hair cortisol
timeFrame: 13-20 weeks after baseline
measure: Child stress hormones
timeFrame: Pre-intervention baseline
measure: Child stress hormones
timeFrame: 13-20 weeks after baseline
measure: Parenting
timeFrame: Pre-intervention baseline
measure: Parenting
timeFrame: 13-20 weeks after baseline
measure: Child wellbeing
timeFrame: Pre-intervention baseline
measure: Child wellbeing
timeFrame: 13-20 weeks after baseline
measure: Child executive functioning
timeFrame: Pre-intervention baseline
measure: Child executive functioning
timeFrame: 13-20 weeks after baseline
measure: Child mental health
timeFrame: Pre-intervention baseline
measure: Child mental health
timeFrame: 13-20 weeks after baseline
measure: Caregiver anxiety
timeFrame: Pre-intervention baseline
measure: Caregiver anxiety
timeFrame: 13-20 weeks after baseline
measure: Caregiver depression
timeFrame: Pre-intervention baseline
measure: Caregiver depression
timeFrame: 13-20 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: South Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Danielle Roubinov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Dozier, M., Bernard, K., Roben, C. K., Steele, H., & Steele, M. (2017). Attachment and biobehavioral catch-up. Handbook of attachment-based interventions, 27-49.
citation: 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.