Parenting Program for Stress in Children

(RISE Trial)

Overseen By Danielle Rouvinov, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Steroids

Disqualifiers: Genetic disorders, Cerebral palsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. However, children using steroid medications are excluded from the study, which might imply some restrictions.

What data supports the effectiveness of the treatment Attachment and Biobehavioral Catch-up (ABC) for stress in children?

Research shows that the ABC treatment helps children express fewer negative emotions and improves their ability to handle stress, especially in families involved with child welfare services. It also enhances parental sensitivity, which is important for children's emotional and behavioral development. ^{1 2 3 4 5}

Is the Attachment and Biobehavioral Catch-up (ABC) program safe for children?

The research does not report any safety concerns for the Attachment and Biobehavioral Catch-up (ABC) program, which is designed to help parents provide nurturing care to improve children's emotional and behavioral regulation. ^{1 2 3 4 6}

How is the ABC Parenting Program different from other treatments for stress in children?

The ABC Parenting Program is unique because it focuses on enhancing parental sensitivity and nurturing behaviors through a 10-session home visiting program, which helps improve children's self-regulation and attachment security. Unlike other treatments, it provides parents with practice and feedback on interacting sensitively with their children, making it particularly effective for children exposed to early adversity. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Research Team

Danielle Roubinov, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for caregiver-child pairs where the child is aged 24-54 months and has faced social challenges. Caregivers must speak English or Spanish. The study excludes those who don't meet these language and age requirements, or cannot commit to the study timeline.

Inclusion Criteria

Parent/Caregiver: Is a primary caregiver/parent

My child is between 2 and 3.5 years old.

Child: Lives with the parent/caregiver at least 50% of the time

Exclusion Criteria

My child has a condition like Down syndrome, cerebral palsy, or was born with birth defects.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ABC parenting program immediately or after a 4-month waitlist period, involving 10 sessions

10 weeks

10 sessions (in-person)

Follow-up

Participants are monitored for stress biomarkers and other outcomes after treatment

13-20 weeks

Treatment Details

Interventions

• Attachment and Biobehavioral Catch-up (ABC)

Trial Overview The trial tests a parenting program called Attachment and Biobehavioral Catch-up (ABC) on children's stress markers. Half of participants start ABC immediately, while the other half wait for about 4 months before beginning. It involves surveys, play tasks, and collecting biological samples.

Participant Groups

Group I: Waitlist-Control (ABC after delay) Experimental Treatment 2 Interventions

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

Group II: ABC Program - no wait Experimental Treatment 1 Intervention

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

Attachment and Biobehavioral Catch-up (ABC) is already approved in United States for the following indications:

Approved in United States as Attachment and Biobehavioral Catch-up for:

• Parenting support for children aged 0-48 months
• Stress reduction in children
• Improvement of child-caregiver attachment

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

The Duke Endowment

Collaborator

Trials

17

Recruited

48,100+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Findings from Research

The Attachment and Biobehavioral Catch-up (ABC) intervention, consisting of 10 sessions, effectively improved self-regulation in children exposed to early adversity, as evidenced by lower negative affect in children during challenging tasks.

In a randomized clinical trial involving 117 parent-child dyads referred to Child Protective Services, children who received the ABC intervention (n=56) showed better emotional regulation compared to those in the control group (n=61).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention effects on negative affect of CPS-referred children: results of a randomized clinical trial. Lind, T., Bernard, K., Ross, E., et al.[2021]

The Attachment and Biobehavioral Catch-Up (ABC) intervention aims to improve parental sensitivity and nurturing behaviors, which are crucial for fostering secure attachments and self-regulation in vulnerable children.

This intervention is particularly important for parent-child dyads in the child welfare system, as it addresses the unique challenges faced by families involved with Child Protective Services, such as those affected by domestic violence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Attachment and Biobehavioral Catch-Up with birth parents: Rationale and case example. Hoye, JR., Dozier, M.[2019]

The Attachment Biobehavioral Catch-up (ABC) intervention is effective in improving emotional regulation, behavior, and attachment quality in children aged 6 months to 2 years, particularly those involved with child welfare, based on a systematic review of 10 randomized control trials.

ABC is recognized as a Level 1 evidence-based practice, highlighting its strong support in the field of child welfare and mental health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ATTACHMENT AND BIOBEHAVIORAL CATCH-UP: A SYSTEMATIC REVIEW. Grube, WA., Liming, KW.[2019]

The Attachment and Biobehavioral Catch-up (ABC) program, consisting of 10 home visits, effectively enhances parental sensitivity, which is crucial for the healthy development of infants and young children.

The program not only improves parental responsiveness but also strengthens children's attachment security and self-regulatory skills, with strong results attributed to careful monitoring of treatment fidelity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attachment and Biobehavioral Catch-up: Addressing the Needs of Infants and Toddlers Exposed to Inadequate or Problematic Caregiving. Dozier, M., Bernard, K.[2022]

The Attachment and Biobehavioral Catch-up (ABC) intervention significantly improved parental sensitivity and reduced depression symptoms among parents of infants aged 5 to 21 months in a community setting, based on a study involving 200 parents.

The effectiveness of the ABC intervention was consistent regardless of sociodemographic risk factors, suggesting it can be broadly applied to diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing parental depression and sensitivity: Randomized clinical trial of ABC's effectiveness in the community. Perrone, L., Imrisek, SD., Dash, A., et al.[2022]

The Attachment and Biobehavioral Catch-up (ABC) program effectively enhances parental sensitivity in families facing early adversity, showing results comparable to those seen in controlled clinical trials.

By implementing a microanalytic fidelity assessment during training and supervision, the program was successfully delivered to 108 families, achieving significant improvements in parent sensitivity, which suggests a promising approach for scaling evidence-based interventions in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving an Evidence-Based Parenting Program Into the Community. Roben, CKP., Dozier, M., Caron, EB., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Intervention effects on negative affect of CPS-referred children: results of a randomized clinical trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Implementing Attachment and Biobehavioral Catch-Up with birth parents: Rationale and case example. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

ATTACHMENT AND BIOBEHAVIORAL CATCH-UP: A SYSTEMATIC REVIEW. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Attachment and Biobehavioral Catch-up: Addressing the Needs of Infants and Toddlers Exposed to Inadequate or Problematic Caregiving. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Changing parental depression and sensitivity: Randomized clinical trial of ABC's effectiveness in the community. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Moving an Evidence-Based Parenting Program Into the Community. [2018]