Attachment-Based Intervention for Child Health Outcomes

Overseen By Roderick Rose, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Premature birth, Heart conditions, Autoimmune, others

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

Compensation: Varies

Number of Visits: 10

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this randomized controlled trial is to evaluate the impacts of an attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood illnesses, body mass index, and sleep) in low-income Latino children (N=260; 9 months at enrollment). It is hypothesized that children randomized to ABC will have better health outcomes in comparison to the HBOW control group.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is the Attachment-Based Intervention for Child Health Outcomes safe for humans?

The Attachment and Biobehavioral Catch-Up (ABC) program has been tested in several studies and is generally considered safe for both parents and children. It focuses on improving parent-child interactions and has shown positive effects on child behavior and parent sensitivity without reported safety concerns. ^{1 2 3 4 5}

How is the Attachment and Biobehavioral Catch-Up treatment different from other treatments for child health outcomes?

The Attachment and Biobehavioral Catch-Up (ABC) treatment is unique because it is a 10-session home visiting program that focuses on improving child emotion regulation and attachment by teaching parents to provide nurturing and appropriate interactions. Unlike other treatments, ABC specifically targets parents of young children who have experienced early adversity, and it has been shown to be effective in randomized clinical trials. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment Attachment and Biobehavioral Catch-Up (ABC)?

Research shows that the ABC treatment helps improve parent sensitivity and reduce depression symptoms in community settings. It also enhances attachment quality in children, leading to more secure attachments and fewer disorganized attachments, especially among families at risk for neglect. ^{1 4 5 6 8}

Who Is on the Research Team?

Lisa Berlin, PhD

Principal Investigator

University of Maryland

Natalie Slopen, PhD

Principal Investigator

Harvard School of Public Health (HSPH)

Cathi Propper, PhD

Principal Investigator

Department of Psychology and Neuroscience at UNC Chapel Hill

Are You a Good Fit for This Trial?

This trial is for Latina mothers with a 9-month-old child enrolled in Medicaid. The child must be born at full term without major complex medical conditions like heart or autoimmune diseases that could affect participation.

Inclusion Criteria

My 9-month-old child is enrolled in Medicaid.

Women who are having their first baby and women who have had more than one baby.

You are of Latin American descent.

Exclusion Criteria

My child has a serious health condition that could affect their participation in the study.

I was born before 37 weeks of pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the ABC program or the HBOW program over 10 weeks

10 weeks

10 home-based sessions

Post-Intervention Assessment

Two post-intervention assessments are conducted to evaluate outcomes

Approximately 12 months

Follow-up

Participants are monitored for health outcomes such as sleep, BMI, and common childhood illnesses

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Attachment and Biobehavioral Catch-Up
• Home-Based Book-of-the-Week

Trial Overview The study tests an attachment-based intervention (ABC) against a Home Book-of-the-Week program, focusing on health outcomes such as illnesses, body mass index, and sleep in low-income Latino children.

How Is the Trial Designed?

Group I: Attachment and Biobehavioral Catch-up (ABC) program Experimental Treatment 1 Intervention

The ABC program consists of 10 1 -hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic.

Group II: Home-Based Book-of-the-Week (HBOW) program Active Control 1 Intervention

The HBOW program consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. A trained RA will utilize a standard set of questions to ask about the mother's and child's well-being.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

The Attachment and Biobehavioural Catch-Up (ABC) program, a 10-session home visiting intervention, has shown a significant small to medium effect on improving attachment-related outcomes for parents with psychosocial risk factors, based on a review of 11 controlled trials.

The program particularly enhanced parental sensitivity, indicating that ABC can positively influence caregiver behaviors that are crucial for child development, although further research is needed to identify the most effective target populations and compare it with other interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of the "Attachment and Biobehavioural Catch-Up" program on attachment related parent behavior-A systematic review. O'Byrne, E., McCusker, C., McSweeney, S.[2023]

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) 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]

Attachment-based interventions for caregivers of toddlers (12-24 months) can lead to improved attachment security, with Child-Parent Psychotherapy and Attachment and Biobehavioral Catch-Up showing the strongest evidence for effectiveness.

Most of the evidence supporting these interventions comes from single studies, often lacking randomized controlled trials, highlighting the need for more rigorous research to confirm their efficacy across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attachment-Based Parenting Interventions and Evidence of Changes in Toddler Attachment Patterns: An Overview. Kohlhoff, J., Lieneman, C., Cibralic, S., et al.[2022]

The Attachment and Biobehavioral Catch-up (ABC) intervention significantly reduced disorganized attachment rates to 32% and increased secure attachment rates to 52% among 120 young children at risk for neglect, compared to control groups.

This randomized clinical trial demonstrates the effectiveness of the ABC intervention in improving attachment quality in children aged 11.7 to 31.9 months, highlighting its potential as a valuable tool for parents at risk of maltreatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing attachment organization among maltreated children: results of a randomized clinical trial. Bernard, K., Dozier, M., Bick, J., et al.[2021]

The Attachment and Biobehavioral Catch-Up (ABC) intervention, provided during infancy, significantly improved perceived attachment security in middle childhood for children referred by Child Protective Services, as measured by the Kerns Security Scale at age nine.

This study, involving 100 children, highlights the long-term efficacy of a brief 10-session intervention in enhancing caregiving quality and attachment security, demonstrating benefits that persisted for eight years post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained effects on attachment security in middle childhood: results from a randomized clinical trial of the Attachment and Biobehavioral Catch-up (ABC) intervention. Zajac, L., Raby, KL., Dozier, M.[2021]

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 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]

Citations

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

The impact of the "Attachment and Biobehavioural Catch-Up" program on attachment related parent behavior-A systematic review. [2023]

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

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

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

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

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

Attachment-Based Parenting Interventions and Evidence of Changes in Toddler Attachment Patterns: An Overview. [2022]

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

Enhancing attachment organization among maltreated children: results of a randomized clinical trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Sustained effects on attachment security in middle childhood: results from a randomized clinical trial of the Attachment and Biobehavioral Catch-up (ABC) intervention. [2021]

7. England pubmed.ncbi.nlm.nih.gov

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

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

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