Clinical trial NCT04737564: Boosting Infant Resilience and Development
Official title: Attachment and Biobehavioral Catch-up With Child Protective Services-Involved Parents: Testing Effectiveness in the Community
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Maltreatment
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: University of Delaware
First posted: 2021-02-04
Enrollment: 360
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The standard Attachment and Biobehavioral Catch-up intervention (ABC10) is a 10-session home-visiting intervention. 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.
Primary purpose: PREVENTION

Brief 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.

Detailed description: This effectiveness trial leverages an existing partnership between Power of Two, a non-profit organization in New York City (NYC) that delivers the ABC intervention to infants with child welfare involvement; NYC's Administration for Children Services (ACS) that oversees the child welfare system; and ACS-contracted preventive agencies that refer families to Power of Two. We will assess the effectiveness of the ABC intervention in engaging parental sensitivity, the intervention mechanism, using a multi-method approach (behavioral observation, neural activity via event-related potentials \[ERP\]), and in enhancing child outcomes; we will assess whether the purported intervention mechanism mediates the association between the intervention and child outcomes; and we will examine moderators of treatment effectiveness that could allow personalizing the intervention to individual needs. Participants will include 360 parents and their 6- to 24-month-old infants with indicated reports of maltreatment. Parents will be randomized to one of three conditions: an evidence-based screen-and-refer intervention (Safe Environment for Every Child \[SEEK\]16), SEEK plus the first three sessions of ABC (ABC 3), or SEEK plus the standard ABC protocol (ABC 10). Parents and their young children will be assessed at intake, after ABC session 3 (or equivalent for SEEK only condition), and at 6 and 12 months post-intake. Parental sensitivity and child functioning will be assessed at each time-point, and parental neural activity will be assessed at intake and 6 months post-intake.

The proposed research will address the following aims:

Aim 1: Examine effectiveness of the ABC intervention in a community context.

1a. Examine whether the ABC intervention engages the treatment mechanism. Parents randomized to ABC 10 are expected to show greater gains in observed sensitivity than parents randomized to SEEK.

1b. Examine whether ABC enhances parental neural activity. Parents randomized to ABC 10 are expected to show greater gains in neural activity associated with sensitivity than parents randomized to SEEK.

1. c. Examine whether the ABC intervention affects child outcomes. Children of parents randomized to ABC 10 are expected to show lower rates of disorganized attachment, more normative cortisol production, and less behavioral dysregulation than children of parents randomized to SEEK.

   Aim 2: Examine mediation effects.
2. a. Examine the extent to which target engagement leads to changes in child outcomes. Changes in parental sensitivity are expected to mediate the association between intervention participation and child outcomes.

2b. Examine whether changes in parental neural activity are key for sustained change in parental sensitivity. Changes in parental neural activity are expected to mediate the association between intervention participation and parental sensitivity.

Aim 3 (Exploratory): Examine moderation effects. Examine whether cumulative risk moderates intervention effects. More specifically, we will explore whether parents with lower cumulative risk indices respond more favorably to ABC 3 than parents with higher cumulative risk indices, whereas those with higher cumulative risk indices require the full ABC 10 protocol. We will also examine other variables, such as child sex, as possible moderators.

Eligibility criteria: Inclusion Criteria:

* Have an open preventive case following an indicated report of maltreatment (to be confirmed by referring agency)
* Reside in Brooklyn or the Bronx
* Be the biological parent and primary caregiver of a child between 6 and 24 months old, and - Identify English or Spanish as their preferred language.

Exclusion Criteria:

- None

Primary outcomes:
measure: Parental sensitivity
timeFrame: Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)
measure: Parental sensitivity
timeFrame: At 6-months post-intake
measure: Parental sensitivity
timeFrame: At 12-months post-intake
measure: Parental neural activity: N170 to emotional faces
timeFrame: 6 months post-intake
measure: Parental neural activity: Late positive potential (LPP) to emotional faces
timeFrame: 6 months post-intake
measure: Child attachment
timeFrame: 6 months post-intake
measure: Child diurnal cortisol rhythm at 6 months post-intake
timeFrame: 6 months post-intake
measure: Child diurnal cortisol rhythm at 12 months post-intake
timeFrame: 12 months post-intake
measure: Child behavior regulation (Infant Externalizing Questionnaire) after ABC session 3 (or equivalent)
timeFrame: Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)
measure: Child behavior regulation (Infant Externalizing Questionnaire) at 6 months post-intake
timeFrame: 6 months post-intake
measure: Child behavior regulation (Infant Externalizing Questionnaire) at 12 months post-intake
timeFrame: 12 months post-intake
measure: Child behavior regulation (Child Behavior Checklist) at 6 months post-intake
timeFrame: 6 months post-intake
measure: Child behavior regulation (Child Behavior Checklist) at 12 months post-intake
timeFrame: 12 months post-intake
measure: Child behavior regulation (Disruptive Behavior Diagnostic Observation Schedule) at 6 months post-intake
timeFrame: 6 months post-intake
Secondary outcomes:
measure: Client satisfaction with services after ABC Session 3 (or equivalent)
timeFrame: Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)
measure: Client satisfaction with services at 6 months post-intake
timeFrame: 6 months post-intake
measure: Child maltreatment after ABC Session 3 (or equivalent)
timeFrame: Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)
measure: Child maltreatment at 6 months post-intake
timeFrame: 6 months post-intake
measure: Child maltreatment at 12 months post-intake
timeFrame: 12 months post-intake
Other outcomes:
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Study officials:
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