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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| The Duke Endowment | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC Program - no wait | Experimental | Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attachment and Biobehavioral Catch-up (ABC) | Behavioral | 10-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior. |
| 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 |
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Parent/Caregiver Inclusion Criteria :
Child Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Rouvinov, PhD | Contact | 919-843-5898 | roubinov@email.unc.edu | |
| Nicole Bush, PhD | Contact | 415-476-7655 | Nicole.Bush@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Danielle Roubinov, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | South Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31611402 | Background | 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. | |
| 38295654 |
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Deidentified individual data that supports the results, as well as derived data supporting the results.
beginning 9 to 36 months following publication
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.
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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RCT with a waitlist control group
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| 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). |
|
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 |
| 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. |
| 35535547 | 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. |
| 18606034 | 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. |
| 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. |
| 36650307 | 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. |