Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention

June 18, 2026 updated by: Lisa Berlin, University of Maryland, Baltimore

Effects of Attachment-Based Intervention on Low-Income Latino Children's Emerging Health Outcomes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

The proposed RCT will test the impacts of the Attachment Biobehavioral Catch-up (ABC) intervention program on child health outcomes. A total of 260 male and female infants will be enrolled in this study, with an age range of 8-12 months (infant) and 13 months- 23 months (toddler). This study will enroll primiparous and multiparous mothers who identify as Latina, speak English or Spanish, and have a 9-month-old child enrolled in Medicaid at the start of the study. Participants will be recruited in collaboration with the Children's Medical Practice (CMP) at Johns Hopkins Bayview Medical Center and matriculated on a rolling basis. Each participant will participate for approximately 15 months; the time required to complete the Time 1 assessment, either 10-week condition, and the two post-intervention assessments. The entire study is anticipated to be completed in 5 years. This RCT will test maternal sensitivity and child stress regulation as mediators of intervention effects. It will also examine the extent to which sociocultural factors moderate the effects of ABC. Behavioral methods and procedures will include surveys/questionnaires, audio/video recordings, individual or group behavioral observations, psychosocial or behavioral interventions, and other psychosocial or behavioral procedures. This RCT is powered to detect small-medium intervention effects (Cohen's d's= 0.35 - 0.50). These effect sizes align with previous studies, which have shown small to large effects on maternal sensitivity (d's = 0.23 - 0.77) and small to medium effects on main and moderated child behavioral stress regulation (d's= 0.15 - 0.48) and child physiological (cortisol) regulation, via maternal sensitivity (d=-0.36). For .80 power or higher and a two-tailed significance level of .05, power analyses performed using Optimal Design, Webpower, and Gpower software indicated a post-attrition sample size of N=221 will adequately detect main, mediated, and moderated effects of comparable size. Analyses will be conducted in SAS 9.4, SPSS 25.0, and Mplus 8 and will include regression and structural equation models. Missing data will be accommodated using multiple imputations and/or full information maximum likelihood (FIML) and estimators that are robust to non-normality when missing data are present (e.g., MLR). Data safety monitoring will be conducted by the Principal Investigators and the external Data Safety and Monitoring Board, who will review adverse events, enrollment numbers, procedure reports, raw data, outcomes, preliminary analyses, and other data which will be completed on an ongoing basis and reported to the IRB and a sponsor. Study findings stand to inform the nature and timing of preventive interventions to reduce health disparities that disproportionately impact Latino families and will advance understanding of early social influences that promote health development across the lifespan.

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 (Estimated)

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.
260

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.

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Biological mothers
  • Identify as Latina
  • Speak English or Spanish
  • Primiparous and multiparous
  • Have a 9-month-old child enrolled in Medicaid

Exclusion Criteria:

  • Children born prematurely (gestational age < 37 weeks)
  • Children who have major complex medical conditions (e.g., heart or autoimmune conditions) that could interfere with participation in intervention sessions and/or research assessments.

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 Assignment
  • 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: Attachment and Biobehavioral Catch-up (ABC) program
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.
Behavioral: Attachment and Biobehavioral Catch-Up
The ABC program consists of 10 one-hour home-based sessions delivered by a trained parent coach. Each session includes the mother and her child together and addresses a specific topic. Principal intervention activities include a discussion of basic attachment principles, guided practice of new parenting behaviors, and a review of video clips from previous sessions to help reinforce parenting targets. The parent coach promotes (a) nurturance, especially in response to distress; (b) following the child's lead with delight; and (c) avoiding frightening caregiving behavior. As specified by the ABC protocol, any/all other family members will be invited to observe or participate in each ABC session Each full-time ABC parent coach will serve 8 to 10 families at a time (i.e., complete 8-10 hourly ABC visits per week).
Other Names:
  • ABC
Active Comparator: Home-Based Book-of-the-Week (HBOW) program
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.
Other: Home-Based Book-of-the-Week
The HBOW program is an active control condition developed by PI Berlin. It consists of 10 English/Spanish developmentally appropriate books hand-delivered weekly to the mothers. During each of the 10 weeks, a trained RA will visit each HBOW mother to drop off the book and to ask briefly about the mother's and child's well-being (using a standard set of questions). Thus, this condition will parallel the intervention condition in duration (number of weeks) and structure, although it will be less intensive in terms of participant contact time per visit.
Other Names:
  • HBOW

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
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
Time Frame: This data will be gathered at Time 1 (9 months).
This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
This data will be gathered at Time 1 (9 months).
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
Time Frame: This data will be gathered at Time 2 (15 months).
This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
This data will be gathered at Time 2 (15 months).
Common Childhood Illnesses (cough, runny nose, prescribed antibiotic use)
Time Frame: This data will be gathered at Time 3 (24 months).
This outcome will be assessed via maternal report and review of the child's electronic health record (EHR). Using the International Classification of Primary Care, mother's responses will be coded into one of five categories reflecting the frequency of general illnesses, respiratory illnesses, digestive illnesses, skin conditions, and antibiotic use.
This data will be gathered at Time 3 (24 months).
Rapid Weight Gain
Time Frame: This data will be gathered at Time 1 (9 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
This data will be gathered at Time 1 (9 months).
Rapid Weight Gain
Time Frame: This data will be gathered at Time 2 (15 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
This data will be gathered at Time 2 (15 months).
Rapid Weight Gain
Time Frame: This data will be gathered at Time 3 (24 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
This data will be gathered at Time 3 (24 months).
Expressive Speech Delay
Time Frame: This data will be gathered at Time 1 (9 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
This data will be gathered at Time 1 (9 months).
Expressive Speech Delay
Time Frame: This data will be gathered at Time 2 (15 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
This data will be gathered at Time 2 (15 months).
Expressive Speech Delay
Time Frame: This data will be gathered at Time 3 (24 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
This data will be gathered at Time 3 (24 months).
Other Pediatric Health Problem(s)
Time Frame: This data will be gathered at Time 1 (9 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
This data will be gathered at Time 1 (9 months).
Other Pediatric Health Problem(s)
Time Frame: This data will be gathered at Time 2 (15 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
This data will be gathered at Time 2 (15 months).
Other Pediatric Health Problem(s)
Time Frame: This data will be gathered at Time 3 (24 months).
This outcome will be assessed through a review of the children's Electronic Health Record.
This data will be gathered at Time 3 (24 months).
Low Grade Inflammation
Time Frame: This data will be gathered at Time 3 (24 months).
This outcome will be assessed via markers of C-reactive protein (CRP) and interleukin-6 (IL-6) through a collection of blood spots using a traditional finger-prick. Blood spot collection is required at the 24-month pediatric well-child visit for all Baltimore City residents.
This data will be gathered at Time 3 (24 months).
Body Mass Index
Time Frame: This data will be gathered at Time 1 (9 months).
This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
This data will be gathered at Time 1 (9 months).
Body Mass Index
Time Frame: This data will be gathered at Time 2 (15 months).
This outcome will be collected by an RA by measuring the child's length and weight. Length will be measured using a measurement board. All weight measurements will be obtained in a clean diaper utilizing an infant scale (Seca 374). In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
This data will be gathered at Time 2 (15 months).
Body Mass Index
Time Frame: This data will be gathered at Time 3 (24 months).
This outcome will be collected through mothers reports about their children's current length and weight. In addition to this, the child's EHR will be reviewed to extract length and weight data. BMI scores will be calculated using the World Health Organization sex-specific BMO-for-age growth charts per recent guidance for research on early obesity risk.
This data will be gathered at Time 3 (24 months).
Sleep: Age 9 months
Time Frame: Sleep data will be gathered at Time 1 (age 9 months).
This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
Sleep data will be gathered at Time 1 (age 9 months).
Sleep: At 9 months
Time Frame: Sleep data will be gathered at Time 1 (at 9 months).
An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
Sleep data will be gathered at Time 1 (at 9 months).
Sleep: Age 15 months
Time Frame: Sleep data will be gathered at Time 2 (age 15 months).
This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
Sleep data will be gathered at Time 2 (age 15 months).
Sleep: At 15 months
Time Frame: Sleep data will be gathered at Time 2 (at 15 months).
An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
Sleep data will be gathered at Time 2 (at 15 months).
Sleep: Age 24 months
Time Frame: Sleep data will be gathered at Time 3 (age 24 months).
This outcome will be assessed using actigraphy and maternal report. A MotionWatch-8 actigraph will be placed on the child's ankle for continuous (24-hour) recording of body motility in 1-minute epochs. Values will be aggregated over 5 days to assess day/night sleep start times, minutes awake, and sleep efficiency. A total of 7 days of data will be collected to account for missing days that might occur. After the 7 days, an RA will pick up the watch from the mother. An RA will text the mothers a URL to a brief sleep diary for the collection of subjective reports on sleep variations.
Sleep data will be gathered at Time 3 (age 24 months).
Sleep: At 24 months
Time Frame: Sleep data will be gathered at Time 3 (at 24 months).
An RA will also administer a 33-item Brief Infant Sleep Questionnaire-Revised (BISQ-R) to assess general sleeping habits including bedtime routines, location(s) when the child sleeps, child mood upon wakening, and respondent (maternal) perception of the extent to which the child's sleep is problematic.
Sleep data will be gathered at Time 3 (at 24 months).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal Sensitivity during Semi-Structured Play
Time Frame: This data will be collected at Time 1 (9 months).
This outcome will be assessed with a 15-minute "Three Bag" interaction. The mother will be given vague instructions involving 3 numbered cloth bags, each containing one or more standard, age-graded toys or books, asking that the child spend some time with each. The mother will be informed that she can play or help however she wants. Coders will use the well-established Parent-Child Interaction Rating Scales to assign a global 5-point score for the mother's sensitivity/responsiveness, intrusiveness, and positive regard. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
This data will be collected at Time 1 (9 months).
Maternal Sensitivity during Semi-Structured Play
Time Frame: This data will be collected at Time 2 (15 months).
This outcome will be assessed with a 15-minute "Three Bag" interaction. The mother will be given vague instructions involving 3 numbered cloth bags, each containing one or more standard, age-graded toys or books, asking that the child spend some time with each. The mother will be informed that she can play or help however she wants. Coders will use the well-established Parent-Child Interaction Rating Scales to assign a global 5-point score for the mother's sensitivity/responsiveness, intrusiveness, and positive regard. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
This data will be collected at Time 2 (15 months).
Maternal Sensitivity to Child Distress
Time Frame: This data will be collected at Time 1 (9 months).
This will be assessed in the context of age-graded mild stressors designed to elicit child fear or frustration, all of which have been well-validated. Before each stressor, there will be a 3-minute "baseline" period during which the child will view a neutral video. At Time 1, the stressors will consist of a 4-minute novel toy approach and 3-minute barrier task. At Time 2, the stressors will consist of a 2-minute mask task and a 3-minute barrier task. Following each stressor, there will be a 2-minute child-mother "reunion" when the mother is free to interact with her child however she wants. Mothers will be asked ahead of time not to provide a pacifier or breastfeed during these 2 minutes; after two minutes mothers can interact freely, which will allow researchers to capture mothers' "food to soothe" behaviors. Coders will rate sensitivity to child distress using a 5-point scale. If the child does not display distress, coders will rate the mother's responses to her child's other cues.
This data will be collected at Time 1 (9 months).
Maternal Sensitivity to Child Distress
Time Frame: This data will be collected at Time 2 (15 months).
This will be assessed in the context of age-graded mild stressors designed to elicit child fear or frustration, all of which have been well-validated. Before each stressor, there will be a 3-minute "baseline" period during which the child will view a neutral video. At Time 1, the stressors will consist of a 4-minute novel toy approach and 3-minute barrier task. At Time 2, the stressors will consist of a 2-minute mask task and a 3-minute barrier task. Following each stressor, there will be a 2-minute child-mother "reunion" when the mother is free to interact with her child however she wants. Mothers will be asked ahead of time not to provide a pacifier or breastfeed during these 2 minutes; after two minutes mothers can interact freely, which will allow researchers to capture mothers' "food to soothe" behaviors. Coders will rate sensitivity to child distress using a 5-point scale. If the child does not display distress, coders will rate the mother's responses to her child's other cues.
This data will be collected at Time 2 (15 months).
Maternal Sensitivity during Feeding
Time Frame: This data will be collected at Time 1 (9 months).
This outcome will be assessed in terms of maternal responsiveness to child feeding cues and the use of food to soothe child distress, both of which will be observed throughout the home-based assessments. Each home-based assessment will be schedule to include at least one opportunity to observe child feeding./ A set of developmentally and culturally appropriate snack foods will be provided to facilitated standardized observations of mothers' use of food to soothe child distress. Two validated and complementary behavioral coding schemes, the Responsiveness to Child Feeding Cues Scale and the Food to Soothe scheme will be used. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
This data will be collected at Time 1 (9 months).
Maternal Sensitivity during Feeding
Time Frame: This data will be collected at Time 2 (15 months).
This outcome will be assessed in terms of maternal responsiveness to child feeding cues and the use of food to soothe child distress, both of which will be observed throughout the home-based assessments. Each home-based assessment will be schedule to include at least one opportunity to observe child feeding./ A set of developmentally and culturally appropriate snack foods will be provided to facilitated standardized observations of mothers' use of food to soothe child distress. Two validated and complementary behavioral coding schemes, the Responsiveness to Child Feeding Cues Scale and the Food to Soothe scheme will be used. This will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
This data will be collected at Time 2 (15 months).
Child Stress Regulation: Age 9 months
Time Frame: This data will be collected at Time 1 (9 months).
Video recorded data collected will rate infants' emotion regulation strategies in the context of mild stressors during the above-mentioned three contexts of parenting behaviors. The Laboratory Temperament Assessment Battery will be used to rate the presence/absence of the following 5 behaviors: looks to mother, communicative gestures, looks to the environment, and self-stimulation. A two-proportion score composite will be computed for mother-oriented regulation and self-soothing regulation. Coders will also rate children's emotional reactivity every 5 seconds to analyze emotional reactivity as a covariate. This outcome will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
This data will be collected at Time 1 (9 months).
Child Stress Regulation: Age 15 months
Time Frame: This data will be collected at Time 2 (age 15 months).
Video recorded data collected will rate infants' emotion regulation strategies in the context of mild stressors during the above-mentioned three contexts of parenting behaviors. The Laboratory Temperament Assessment Battery will be used to rate the presence/absence of the following 5 behaviors: looks to mother, communicative gestures, looks to the environment, and self-stimulation. A two-proportion score composite will be computed for mother-oriented regulation and self-soothing regulation. Coders will also rate children's emotional reactivity every 5 seconds to analyze emotional reactivity as a covariate.
This data will be collected at Time 2 (age 15 months).
Child Stress Regulation: At 15 months
Time Frame: This data will be collected at Time 2 (at 15 months).
The child's emotional dysregulation will be assessed by administrating mothers the Infant-Toddler Social and Emotional Assessment (ITSEA). The following three ITSEA subscales will be examined: internalizing, externalizing, and dysregulation. This outcome will be video-recorded for subsequent coding by trained, reliable, and blinded coders.
This data will be collected at Time 2 (at 15 months).

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.
University of Maryland, Baltimore

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.
Johns Hopkins University
Harvard School of Public Health (HSPH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Berlin, PhD, University of Maryland
  • Study Chair: Natalie Slopen, PhD, Harvard School of Public Health (HSPH)
  • Study Chair: Cathi Propper, PhD, Department of Psychology and Neuroscience at UNC Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
October 9, 2023

Primary Completion (Estimated)

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.
January 1, 2028

Study Completion (Estimated)

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.
January 1, 2028

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).
June 6, 2023

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.
August 15, 2023

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.
August 21, 2023

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.
June 23, 2026

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.
June 18, 2026

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.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • HP-00103602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD.

IPD Sharing Time Frame

3-5yrs after initial study publications.

IPD Sharing Access Criteria

There will be only one master database in which participants' ID numbers and personal identifying information are linked. Only Dr. Berlin and the staff members who are directly involved in the data collection and processing will have access to this database. Electronic data will be stored on a secure network, with password protection such that only authorized users will have access to the file server. Any original data documents such as consent forms will be kept in locked compartments separate from identifying documentation. All electronic and paper files that contain identifying information will be destroyed at the conclusion of the research. Published data will not permit the identification of individuals

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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