Boosting Infant Resilience and Development

NCT04737564 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-05-05

No results posted yet for this study

Summary

Childhood maltreatment represents an urgent public health problem, as it is highly prevalent, significantly increases risk for chronically impairing mental health problems, tends to persist across generations, and is very costly to society at large. Leveraging an existing partnership between a community-based organization and child welfare system, this project will examine the effectiveness of the Attachment and Biobehavioral Catch-up (ABC) intervention, which targets sensitivity among parents who have maltreated their children. Findings will have substantial public health impact by assessing the effectiveness of the ABC intervention in a community context, identifying modifiable mechanistic pathways by which the ABC intervention may prevent later mental health problems, and identifying treatment moderators that may promote more targeted, cost-effective approaches to prevention.

Conditions

  • Child Maltreatment

Interventions

BEHAVIORAL

Attachment and Biobehavioral Catch-up (ABC10)

The ABC parenting targets include: nurturing children when they are distressed (Sessions 1 and 2), following the child's lead in play (Sessions 3 and 4), and avoiding harsh or frightening behavior (Sessions 5 and 6). Sessions 7 and 8 help parents consider how their own experiences of being parented affect their sensitivity, and Sessions 9 and 10 consolidate gains with additional practice. Session content focusing on parenting targets is guided by a manual. Additionally, parent coaches make frequent "in-the-moment" comments (at least once per minute) about parent-child interactions as they occur in session, and use video feedback.

BEHAVIORAL

Attachment and Biobehavioral Catch-up, Brief (ABC3)

The 3-session Attachment and Biobehavioral Catch-up intervention (ABC 3) is a brief version of the standard protocol. Parents who receive ABC 3 will receive the first 3 sessions of the ABC intervention, which focus on enhancing parental sensitivity (i.e., nurturance to distress, following the child's lead) by providing in-the-moment feedback on parent-child interactions, video feedback, and discussion of manualized content. ABC 3 was adapted from the standard protocol based on modeling of session-by-session data that demonstrated that, on average, most of the change in parental sensitivity happens in the first several sessions of the intervention.

BEHAVIORAL

Safe Environment for Every Kid (SEEK)

Safe Environment for Every Kid (SEEK) is an evidence-based screening and referral system to facilitate parents' access to services for risk factors for maltreatment, including: mental health, substance abuse, intimate partner violence, harsh parenting, major parental stress, and food insecurity. Parents first complete the SEEK Parent Questionnaire with the help of an outreach worker. Following the SEEK protocol, handouts will be provided that address the identified problems and parents will be referred to partnering organizations in the community. Any additional work is completed by phone. The developer of the intervention, Howard Dubowitz, is a consultant on this application and will provide support around effective implementation.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2025-06-30
Completion
2025-06-30

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737564 on ClinicalTrials.gov