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NCT Number: NCT06669624

Resilience Through Interventions for Successful Early Outcomes

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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Key information

Conditions

Parenting Intervention Behavior Caregiver Child Relationship Child Behavior Child Behavior Problem Mental Health Personal Satisfaction Psychological Well-Being Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, South Carolina, 27599, United States

Location status: Recruiting

Location contact

Natalie O'Brien

CONTACT

[email protected]

919-966-0421

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Attachment and Biobehavioral Catch-up (ABC)

Behavioral

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

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).

Primary outcomes

  1. Child inflammation

    Time frame: Pre-intervention baseline

    Pediatric saliva samples will be assayed for cytokine concentrations.

  2. Child inflammation

    Time frame: 13-20 weeks after baseline

    Pediatric saliva samples will be assayed for cytokine concentrations.

  3. Child epigenetic age acceleration

    Time frame: Pre-intervention baseline

    Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age

  4. Child epigenetic age acceleration

    Time frame: 13-20 weeks after baseline

    Pediatric buccal swabs will be assayed for DNAm, which will be used to calculate child epigenetic age

  5. Child telomere length

    Time frame: Pre-intervention baseline

    DNA will be extracted from child buccal swabs to calculated T/S ratios.

  6. Child telomere length

    Time frame: 13-20 weeks after baseline

    DNA will be extracted from child buccal swabs to calculated T/S ratios.

  7. Child hair cortisol

    Time frame: Pre-intervention baseline

    Several strands of hair will be collected and assayed to obtain hair cortisol concentration

  8. Child hair cortisol

    Time frame: 13-20 weeks after baseline

    Several strands of hair will be collected and assayed to obtain hair cortisol concentration

  9. Child stress hormones

    Time frame: Pre-intervention baseline

    Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses.

  10. Child stress hormones

    Time frame: 13-20 weeks after baseline

    Child hair and saliva samples for cortisol, cortisone, DHEA, progesterone, and endocannabinoid levels to examine both cumulative and dynamic stress hormone responses.

  11. Parenting

    Time frame: Pre-intervention baseline

    Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.

  12. Parenting

    Time frame: 13-20 weeks after baseline

    Behavioral coding of parenting will be conducted using video recordings of tasks from the Early Regulation in Context Assessment.

  13. Child wellbeing

    Time frame: Pre-intervention baseline

    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.

  14. Child wellbeing

    Time frame: 13-20 weeks after baseline

    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.

  15. Child executive functioning

    Time frame: Pre-intervention baseline

    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.

  16. Child executive functioning

    Time frame: 13-20 weeks after baseline

    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.

  17. Child mental health

    Time frame: Pre-intervention baseline

    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.

  18. Child mental health

    Time frame: 13-20 weeks after baseline

    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.

  19. Caregiver anxiety

    Time frame: Pre-intervention baseline

    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.

  20. Caregiver anxiety

    Time frame: 13-20 weeks after baseline

    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.

  21. Caregiver depression

    Time frame: Pre-intervention baseline

    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.

  22. Caregiver depression

    Time frame: 13-20 weeks after baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Rouvinov, PhD

CONTACT

[email protected]

919-843-5898

Nicole Bush, PhD

CONTACT

[email protected]

415-476-7655

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • The Duke Endowment
  • University of California, San Francisco

Registry information

Official study title

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

Acronym: RISE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 1, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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