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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how the Attachment and Biobehavioral Catch-up (ABC) parenting program affects stress levels in young children. The program focuses on enhancing parenting skills to support children who have faced challenges such as low income or family stress. Participants will either begin the program immediately or join after a few months. Ideal participants are caregivers who speak English or Spanish and have children aged 24 to 42 months who have experienced social challenges. As an unphased trial, this study provides caregivers the opportunity to contribute to valuable research that could enhance parenting strategies and improve children's well-being.

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 prior data suggests that the ABC parenting program is safe for children?

Research has shown that the Attachment and Biobehavioral Catch-up (ABC) program is a well-received parenting program. It consists of 10 home sessions designed to help parents develop skills such as sensitivity and warmth with their children. Studies confirm the program's safety for both parents and children, with no reports of negative effects. The program supports and positively enhances caregiver-child interactions. As it involves no medications or medical procedures, it is considered very safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Attachment and Biobehavioral Catch-up (ABC) program because it offers a fresh approach to addressing stress in children by focusing directly on improving parenting practices. Unlike traditional therapies that often center on directly treating the child, the ABC program targets parenting sensitivity and nurturance, aiming to strengthen the parent-child relationship and, consequently, reduce stress in children. This method's home-based delivery makes it uniquely accessible and practical, potentially leading to more profound, lasting changes in family dynamics and child well-being.

What evidence suggests that the ABC Parenting Program is effective for reducing stress in children?

Studies have shown that the Attachment and Biobehavioral Catch-up (ABC) program helps parents respond more effectively to their children's needs and enhances children's emotional regulation. Research indicates that children who participate in the ABC program often feel more secure and supported by their caregivers. In past studies, using ABC with children in child welfare led to noticeable improvements in emotional management. These changes suggest that ABC can positively affect stress indicators in children. Overall, ABC has demonstrated lasting benefits for children's emotional and behavioral health. Participants in this trial will receive the ABC program either immediately or after a four-month waitlist period, allowing for a comparison of immediate versus delayed intervention effects. ^{2 4 6 7 8}

Who Is on the Research Team?

Danielle Roubinov, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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

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

My child is between 2 and 3.5 years old.

Exclusion Criteria

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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) 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) 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5477793/

Attachment and Biobehavioral Catch-up - PubMed Central - NIH ABC has been shown effective in enhancing parental sensitivity, and enhancing children's attachment security and regulatory capabilities. A key feature of the ...

2. nctsn.org nctsn.org/sites/default/files/interventions/attachment-and-biobehavioral-catch-up-072025.pdf

Attachment and Biobehavioral Catch-up (ABC) Attachment and Biobehavioral Catch-up (ABC) is a 10-session home visiting program designed for parents of children from birth through 48 months.

3. apadivisions.org apadivisions.org/division-7/publications/newsletters/developmental/2019/01/biobehavioral-intervention

The Attachment and Biobehavioral Catch-Up (ABC) Intervention We have assessed the efficacy of the ABC intervention through randomized, controlled trials and found striking and lasting effects on children's ...

4. massaimh.org massaimh.org/wp-content/uploads/2020/02/Attachment-and-Biobehavioral-Catch-Up-Dozier-et-al-2016.pdf

Attachment-and-Biobehavioral-Catch-Up-Dozier-et-al- ... ABC intervention parents reported levels of problem behaviors that were not significantly differ from levels reported by parents in the control ...

5. researchgate.net researchgate.net/publication/328545291_ATTACHMENT_AND_BIOBEHAVIORAL_CATCH-UP_A_SYSTEMATIC_REVIEW_ABS_A_Systematic_Review

(PDF) ATTACHMENT AND BIOBEHAVIORAL CATCH-UP Findings indicate that ABC is effective, when implemented with child-welfare-involved children, at improving emotion regulation, improving ...

6. massaimh.org massaimh.org/wp-content/uploads/2020/02/Chapter31AttachmentAndBiobehavior.pdf

Attachment and Biobehavioral Catch-Up ABC is a 10-session parenting intervention focusing on nurturing, following the child's lead, and avoiding harsh behavior, delivered in parents' homes.

7. abcparenting.org abcparenting.org/

ABC Parenting Institute: Welcome ABC Parenting Institute is a non-profit organization that partners with communities to implement the Attachment and Biobehavioral Catch-up (ABC) intervention.

8. nctsn.org nctsn.org/interventions/attachment-and-biobehavioral-catch

Attachment and Biobehavioral Catch-up Attachment and Biobehavioral Catch-up (ABC) is a 10-session home visiting program designed for parents of children from birth through 48 months.