Boosting Infant Resilience and Development

NCT04737564 | Unknown DMC

• 1 other identifier: R01MH119310
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Child Maltreatment

Outcome Measures

Primary Outcomes (14)

• Parental sensitivity

  After ABC Session 3 (or the equivalent for SEEK only dyads), parental sensitivity will be coded on the basis of a 30-minute semi-structured interaction, including a play task and challenge/ distress tasks. The parent will be given 3 bags of toys and asked to play with the toys in each of the three bags in order and complete a series of challenge/distress-eliciting tasks that vary based on child age, such as changing the child's clothes, withholding an attractive toy, and completing research measures while the child is present. We will use the NICHD SECCYD methods for coding parental sensitivity, including scales for sensitivity to distress (consistent with the ABC target of nurturance), sensitivity to non-distress (consistent with the ABC target of following the child's lead), and positive regard (consistent with the ABC target of delight). Raters will be trained to better than 85% inter-rater reliability and reliability will be carefully monitored, with all assessments double-coded.

  Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)

• Parental sensitivity

  At 6 months post-intake (or the equivalent for SEEK only dyads), parental sensitivity will be coded on the basis of a 30-minute semi-structured interaction, including a play task and challenge/ distress tasks. The parent will be given 3 bags of toys and asked to play with the toys in each of the three bags in order and complete a series of challenge/distress-eliciting tasks that vary based on child age, such as changing the child's clothes, withholding an attractive toy, and completing research measures while the child is present. We will use the NICHD SECCYD methods for coding parental sensitivity, including scales for sensitivity to distress, sensitivity to non-distress, and positive regard. Raters will be trained to better than 85% inter-rater reliability and reliability will be carefully monitored, with all assessments double-coded.

  At 6-months post-intake

• Parental sensitivity

  At 12 months post-intake (or the equivalent for SEEK only dyads), parental sensitivity will be coded on the basis of a 30-minute semi-structured interaction, including a play task and challenge/ distress tasks. The parent will be given 3 bags of toys and asked to play with the toys in each of the three bags in order and complete a series of challenge/distress-eliciting tasks that vary based on child age, such as changing the child's clothes, withholding an attractive toy, and completing research measures while the child is present. We will use the NICHD SECCYD methods for coding parental sensitivity, including scales for sensitivity to distress, sensitivity to non-distress, and positive regard. Raters will be trained to better than 85% inter-rater reliability and reliability will be carefully monitored, with all assessments double-coded.

  At 12-months post-intake

• Parental neural activity: N170 to emotional faces

  At 6 months post-intake, parental neural activity will be assessed using an event-related potential (ERP) task. Parents will categorize photographs of infants with different emotional expressions (crying, laughing, neutral), while continuous EEG is recorded (Bernard et al., 2015). The N170 (an early perceptual ERP component that indexes processing of faces) will be measured as the average amplitude within a time window of 140 to 180 ms at electrodes P7 and P8. After data processing (re-referencing, artifact rejection), residualized difference scores will be computed that reflect the magnitude of the difference in N170 responses to emotional faces versus neutral faces.

  6 months post-intake

• Parental neural activity: Late positive potential (LPP) to emotional faces

  At 6 months post-intake, parental neural activity will be assessed using an event-related potential (ERP) task. Parents will categorize photographs of infants with different emotional expressions (crying, laughing, neutral), while continuous EEG is recorded (Bernard et al., 2015). The late positive potential (LPP; a late ERP component that indexes sustained attention and evaluation of emotionally-salient stimuli) will be measured as the average amplitude at the Pz electrode from 300 to 650 ms post-stimulus. After data processing (re-referencing, artifact rejection), residualized difference scores will be computed that reflect the magnitude of the difference in LPP responses to emotional faces versus neutral faces.

  6 months post-intake

• Child attachment

  At 6 months post-intake, the Strange Situation procedure (Ainsworth et al., 1978) will be conducted. The Strange Situation consists of a series of episodes including two 3-minute separations, each followed by 3-minute reunions. The child's behavior upon reunion with the parent is coded for continuous scales (i.e., proximity seeking, contact maintenance, avoidance, resistance) and children are classified as secure, insecure-avoidant, or insecure-resistant. Following the Main \& Solomon (1990) system, disorganized attachment behavior is also coded on a continuous scale, and children may receive a primary classification of disorganized attachment. Elizabeth Carlson, an expert coder, will serve as a consultant on this project and complete reliability coding for 25% of videos.

  6 months post-intake

• Child diurnal cortisol rhythm at 6 months post-intake

  At 6 months post-intake, children's diurnal cortisol rhythms will be assessed. Cortisol is an end product of the hypothalamic-pituitary-adrenal (HPA) axis. The normative pattern is a high wake-up level, decreasing throughout the day, with the nadir in the evening. Parents will collect child saliva samples by rubbing an oral swab in the child's mouth at wake-up (morning) and bedtime (evening) for 3 consecutive days. Saliva samples will be assayed using the Salimetrics, Inc. High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit. All samples from a child at a single time-point will be run in duplicate on the same assay plate, along with a control. Cortisol values, measured in ?g/dl, will be log-transformed. We will examine changes in the diurnal rhythm (i.e., slope) from wake-up to bedtime.

  6 months post-intake

• Child diurnal cortisol rhythm at 12 months post-intake

  At 12 months post-intake, children's diurnal cortisol rhythms will be assessed. Cortisol is an end product of the hypothalamic-pituitary-adrenal (HPA) axis. The normative pattern is a high wake-up level, decreasing throughout the day, with the nadir in the evening. Parents will collect child saliva samples by rubbing an oral swab in the child's mouth at wake-up (morning) and bedtime (evening) for 3 consecutive days. Saliva samples will be assayed using the Salimetrics, Inc. High Sensitivity Salivary Cortisol Enzyme Immunoassay Kit. All samples from a child at a single time-point will be run in duplicate on the same assay plate, along with a control. Cortisol values, measured in ?g/dl, will be log-transformed. We will examine changes in the diurnal rhythm (i.e., slope) from wake-up to bedtime.

  12 months post-intake

• Child behavior regulation (Infant Externalizing Questionnaire) after ABC session 3 (or equivalent)

  After ABC Session 3 (or the equivalent for SEEK-only dyads), parents will complete the Infant Externalizing Questionnaire (IEQ; Lorber et al., 2017) when children are 24 months of age or younger. The IEQ is a measure of infant aggression (7 items) and defiance (4 items) and shows good internal consistency, longitudinal stability, interparental agreement, and concurrent and predictive validity.

  Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)

• Child behavior regulation (Infant Externalizing Questionnaire) at 6 months post-intake

  At 6 months post-intake, parents will complete the Infant Externalizing Questionnaire (IEQ; Lorber et al., 2017) when children are 24 months of age or younger. The IEQ is a measure of infant aggression (7 items) and defiance (4 items) and shows good internal consistency, longitudinal stability, interparental agreement, and concurrent and predictive validity.

  6 months post-intake

• Child behavior regulation (Infant Externalizing Questionnaire) at 12 months post-intake

  At 12 months post-intake, parents will complete the Infant Externalizing Questionnaire (IEQ; Lorber et al., 2017) when children are 24 months of age or younger. The IEQ is a measure of infant aggression (7 items) and defiance (4 items) and shows good internal consistency, longitudinal stability, interparental agreement, and concurrent and predictive validity.

  12 months post-intake

• Child behavior regulation (Child Behavior Checklist) at 6 months post-intake

  At 6 months post-intake, parents will complete the Child Behavior Checklist 1? - 5 (CBCL; Achenbach \& Rescorla, 2001) for children at least 18 months old, which will allow us to assess both internalizing and externalizing behaviors. The use of the IEQ and the CBCL at overlapping waves of data collection is intentional because it allows us to correct for switching indicators in statistical analyses.

  6 months post-intake

• Child behavior regulation (Child Behavior Checklist) at 12 months post-intake

  At 12 months post-intake, parents will complete the Child Behavior Checklist 1? - 5 (CBCL; Achenbach \& Rescorla, 2001), which will allow us to assess both internalizing and externalizing behaviors. The use of the IEQ and the CBCL at overlapping waves of data collection is intentional because it allows us to correct for switching indicators in statistical analyses.

  12 months post-intake

• Child behavior regulation (Disruptive Behavior Diagnostic Observation Schedule) at 6 months post-intake

  At the 6 months post-intake assessment, the Disruptive Behavior Diagnostic Observation Schedule (DB-DOS; Wakschlag et al., 2008) will be administered. The DB-DOS is an observational assessment that involves a series of "presses" that challenge children's emotional and behavioral regulatory capacities; the DB-DOS demonstrates good reliability and validity. Given that children will be between 12 and 30 months at the 6 months post-intake time-point, we will administer the infant/toddler DB-DOS protocol, which allows for the assessment of child irritability and frustration, key behavioral regulation constructs that are predictive of later difficulties with disruptive behavior disorders.

  6 months post-intake

Secondary Outcomes (5)

• Client satisfaction with services after ABC Session 3 (or equivalent)

  Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)

• Client satisfaction with services at 6 months post-intake

  6 months post-intake

• Child maltreatment after ABC Session 3 (or equivalent)

  Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)

• Child maltreatment at 6 months post-intake

  6 months post-intake

• Child maltreatment at 12 months post-intake

  12 months post-intake

Study Arms (3)

ABC10 + SEEK

EXPERIMENTAL

Participants assigned to this arm will receive the standard Attachment and Biobehavioral Catch-up intervention (ABC 10) as well as SEEK (Safe Environment for Every Kid).

Behavioral: Attachment and Biobehavioral Catch-up (ABC10); Behavioral: Safe Environment for Every Kid (SEEK)

ABC3 + SEEK

EXPERIMENTAL

Participants assigned to this arm will receive an abbreviated version of the Attachment and Biobehavioral Catch-up intervention (ABC 3) as well as SEEK (Safe Environment for Every Kid).

Behavioral: Attachment and Biobehavioral Catch-up, Brief (ABC3); Behavioral: Safe Environment for Every Kid (SEEK)

SEEK Only

ACTIVE COMPARATOR

Participants assigned to this arm will receive SEEK (Safe Environment for Every Kid) only.

Behavioral: Safe Environment for Every Kid (SEEK)

Interventions

Attachment and Biobehavioral Catch-up (ABC10) BEHAVIORAL

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.

ABC10 + SEEK

Attachment and Biobehavioral Catch-up, Brief (ABC3) BEHAVIORAL

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.

ABC3 + SEEK

Safe Environment for Every Kid (SEEK) BEHAVIORAL

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.

ABC10 + SEEK; ABC3 + SEEK; SEEK Only

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- None

Sponsors & Collaborators

• Stony Brook University: lead
• University of Delaware: collaborator

Central Study Contacts

Kristin Bernard, PhD

CONTACT

16316327576; kristin.bernard@stonybrook.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 4, 2021
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 5, 2022

Record last verified: 2022-05