Resilience Through Interventions for Successful Early Outcomes (RISE)

University of North Carolina (UNC)

Status: Enrolling

Conditions: Caregiver Child Relationship; Parenting Intervention; Child Behavior Problem; Mental Health; Stress

Treatments: Behavioral: Attachment and Biobehavioral Catch-up (ABC); Other: Waitlist with 4-month delay, then ABC

Study type: Interventional

Funder types: Other

Identifiers

NCT06669624

24-0889

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

ABC Program - no wait

Experimental group

Description:

Participants immediately receive the home-based ABC, which targets parenting sensitivity and nurturance.

Treatment:

Behavioral: Attachment and Biobehavioral Catch-up (ABC)

Waitlist-Control (ABC after delay)

Other group

Description:

Participants will be placed on a four-month waitlist and then receive ABC in the same manner as the Experimental Group

Treatment:

Other: Waitlist with 4-month delay, then ABC

Behavioral: Attachment and Biobehavioral Catch-up (ABC)