Boosting Infant Resilience and Development (earlyBIRD)

May 3, 2022 updated by: Kristin Bernard, Stony Brook University

Attachment and Biobehavioral Catch-up With Child Protective Services-Involved Parents: Testing Effectiveness in the Community

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: ABC10 + SEEK
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)
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: 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.
EXPERIMENTAL: ABC3 + SEEK
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: 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.
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.
ACTIVE_COMPARATOR: SEEK Only
Participants assigned to this arm will receive SEEK (Safe Environment for Every Kid) only.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parental sensitivity
Time Frame: Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)
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
Time Frame: At 6-months post-intake
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
Time Frame: At 12-months post-intake
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
Time Frame: 6 months post-intake
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
Time Frame: 6 months post-intake
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
Time Frame: 6 months post-intake
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
Time Frame: 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
Time Frame: 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)
Time Frame: Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Client satisfaction with services after ABC Session 3 (or equivalent)
Time Frame: Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)
After ABC Session 3 (or the equivalent for SEEK-only dyads), client satisfaction with services will be assessed with the Client Satisfaction Questionnaire (CSQ-8; Larson et al., 1979). The CSQ-8 is an 8-item questionnaire that asks participants about their satisfaction with services received (e.g., to what extent services met needs, likelihood of recommending a friend). The CSQ-8 provides a good measure of participants' perception of services received.
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
Time Frame: 6 months post-intake
At 6 months post-intake, client satisfaction with services will be assessed with the Client Satisfaction Questionnaire (CSQ-8; Larson et al., 1979). The CSQ-8 is an 8-item questionnaire that asks participants about their satisfaction with services received (e.g., to what extent services met needs, likelihood of recommending a friend). The CSQ-8 provides a good measure of participants' perception of services received.
6 months post-intake
Child maltreatment after ABC Session 3 (or equivalent)
Time Frame: Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)
After ABC Session 3 (or the equivalent for SEEK-only dyads), we will assess subsequent reports of maltreatment to ACS, which will be coded as reported, investigated, and substantiated. In addition, we will code available records using the Modified Maltreatment Classification System (Barnett et al., 1993) for type and severity of maltreatment exposure.
Approximately 4 weeks post-intake (After ABC Session 3 or the equivalent for SEEK only dyads)
Child maltreatment at 6 months post-intake
Time Frame: 6 months post-intake
At 6 months post-intake, we will assess subsequent reports of maltreatment to ACS, which will be coded as reported, investigated, and substantiated. In addition, we will code available records using the Modified Maltreatment Classification System (Barnett et al., 1993) for type and severity of maltreatment exposure.
6 months post-intake
Child maltreatment at 12 months post-intake
Time Frame: 12 months post-intake
At 12 months post-intake, we will assess subsequent reports of maltreatment to ACS, which will be coded as reported, investigated, and substantiated. In addition, we will code available records using the Modified Maltreatment Classification System (Barnett et al., 1993) for type and severity of maltreatment exposure.
12 months post-intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stony Brook University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH119310 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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