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The Supporting Early Learning Study (SEAL)

7. september 2022 opdateret af: University of Oregon

RCT of FIND Video Coaching Intervention for Caregivers Facing Economic Adversity

FIND (Filming Interactions to Nurture Development) is a potentially disruptive innovation in the field of early childhood intervention. The scientific premise of this proposed work, for which the investigators have strong preliminary evidence, is that for families experiencing economic adversity and related stressors with children ages 12-36 months, the FIND video-coaching program is a potent and efficient tool that addresses many of the known limitations of existing parenting programs and therefore has great potential for achieving impact at scale to support low-income children's optimal development. Our research on FIND to date (including a recently completed randomized efficacy trial) provides evidence of effects on responsive caregiving and key child developmental outcomes at lower dosages (and with greater potential for scalability) than do most existing programs. Preliminary data also suggest that FIND may be especially effective for caregivers with high levels of adverse early life experiences (who are typically difficult to engage/impact). Finally, and potentially quite noteworthy, preliminary data indicate that FIND may achieve such effects via improvement in specific domains of underlying caregiver brain functioning. This research therefore aims to conduct a randomized effectiveness trial in the context of a diverse sample of low-income families with children ages 12-36 months (at study entry) using a longitudinal design with an active control condition.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The investigators will test the central hypothesis that associations between (a) increases in responsive caregiving (the main FIND target) and (b) subsequent caregiver well-being and child developmental and biobehavioral outcomes (secondary targets), will be partially mediated through (c) changes in caregiver neuroimaging-based and behavioral measures of inhibitory control and parent self-concept. The investigators will also examine moderators of hypothesized intervention effects.

Aim 1: Quantify main effects of FIND on intervention targets (changes in responsive caregiving) and related caregiver and child outcomes.

Hypothesis 1a: Compared with an active control, FIND will significantly increase developmentally supportive, responsive caregiving immediately post-intervention and will endure at the 6-month longitudinal follow-up. These effects will be associated with enduring improvements in self-reported caregiving self-efficacy and stress.

Hypothesis 1b: Compared with an active control, FIND will significantly improve child developmental outcomes on cognitive, socioemotional, expressive language and biobehavioral measures (including child chronic stress assessed via hair cortisol concentrations, HCC and Heart Rate Variability, HRV), as well as measures of caregiver and child well-being. The investigators will also test whether FIND-related increases in responsive caregiving (Hypothesis 1a) are associated (at postintervention and 6-month follow-up) with child outcomes.

Aim 2: Use fMRI to identify process-level neural mechanisms underlying FIND intervention effects (i.e., why FIND works) and variations in these effects (i.e., for whom FIND works). The investigators hypothesize that FIND-related changes in underlying brain and behavioral mechanisms of caregiver inhibitory control and parenting self-concept will partially mediate observed changes in responsive caregiving. The investigators will also determine how between-subjects variation in changes in these brain measures is associated with differential response to sustained intervention impacts on responsive caregiving, which could be key in future work on increasing the impact of FIND for a broader range of recipients and on developing adaptations for low-responding groups.

Aim 3: Determine moderators of intervention impact, including child and caregiver variables and intervention fidelity and dosage. The investigators hypothesize that the relationship between FIND-related changes in caregiver brain activity, caregiving behavior, and caregiver/child outcomes will be moderated by characteristics of the family, including caregiver past/current adversity, family socioeconomic status, and child behavior.

The investigators further hypothesize that intervention effects will be moderated by fidelity and dosage. Work on this aim will subsequently enable the investigators to develop supplemental strategies to support those for whom FIND is less effective.

Assignment to group: Participants will be randomized to one of two conditions (FIND intervention or active control) before their baseline research visit. While multiple caregivers from one family may participate in the FIND intervention or active control condition (which will be documented and included in analyses), the primary caregiver from each eligible family will be the target participant. This participant will be the one randomized to condition, asked to complete the assessments, and, if they are in the FIND condition, the focus of the videos used in the intervention. Similarly, if families have more than one eligible child in the target age range, the investigators will ask caregivers to select one child who will be the focus of the videos and research assessments.

Intervention delivery. For the proposed study, the investigators will train coaches to fidelity to deliver either the FIND intervention or the active control intervention. The investigators have extensive experience and well-established protocols for training and maintaining fidelity during intervention trials, including video-based interventions. To minimize between-group differences in coach demographics, the investigators will match coaches who are delivering each intervention as closely as possible on levels of education and early childhood experience, and will include this information as covariates in our analyses of intervention effects. Although the investigators do not anticipate contamination of the FIND material into the active control, it is noteworthy that such contamination will narrow any differences between the groups, thus providing a more rigorous test of our hypotheses.

FIND intervention. FIND is a brief home-based video coaching intervention. FIND involves feedback provided by the coach to the caregiver using brief film clips derived from video of caregiver-child interaction collected in the home. The coaching focuses specifically and exclusively on showing caregivers instances in which they are engaging in developmentally supportive interactions during coaching sessions. FIND is delivered in 10 weekly home visits, each of which lasts 30-45 minutes. The process begins with an initial visit in which the coach provides an overview, records 10-15 minutes of the caregiver and child engaged in everyday interactions, and then introduces the concept of serve and return. The video is edited to show brief clips in which the caregiver is engaged in the first of five specific and precisely defined caregiver-based components of serve and return. The next week, the FIND coach reviews the edited clips in detail with the caregiver. Sessions continue, alternating between filming and coaching sessions until all five components have been covered sequentially, with each component building on prior ones. The hierarchical nature of the program is intentionally designed so that even partial completion of the program is hypothesized to confer benefits.

FIND editing and coaching processes are fully manualized, including certification protocols, fidelity forms, and rubrics, and designed to be both straightforward and highly replicable. For editing, three short clips are selected from the video gathered in the home. Each clip begins with a brief onscreen text description that is read aloud by the coach, which cues the caregiver to notice the child's initiation (serve) and his/her own supportive response (return). Then the clip plays three times: (1) all the way through; (2) with embedded pauses, which cue the coach to pause and comment on specific elements of the interaction; and (3) all the way through again, giving the caregiver an opportunity to consolidate what he or she has learned. As the clip is playing, the coach narrates the serve and return process. To ensure all families receive the full benefit of FIND, all FIND coaches will participate in the four-phase FIND certification process for coaching and editing, which includes an initial training, fidelity training, application for certification, and certification. The investigators have used this process to train more than 80 certified FIND interventionists to date.

Active control intervention. The active control condition for this study is designed to maximize rigor by controlling for nonspecific effects of FIND (supportive home visiting, child observation, and information about development) to determine the unique impact of the hypothesized "active ingredients" of FIND (i.e., specialized microsocial video coaching on the five caregiver-based components of serve and return). As such, families randomly assigned to the control condition will receive weekly home visits alternating between (a) coaching sessions covering one of five domains of child development (Motor, Cognitive, Language, Play, and Social-Emotional and (b) observation sessions that will include a review of the prior coaching session and an observation and discussion of the caregiver-child interaction. This intervention will consist of 10 home visits each lasting 25-30 minutes. The coach will not engage in any filming or video coaching, but will still be able to discuss caregiving concerns. Materials are adapted from the Partners for a Healthy Baby curriculum developed by Florida State University's Center for Prevention and Early Intervention Policy.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

256

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97403
        • Rekruttering
        • University of Oregon
        • Ledende efterforsker:
          • Philip A Fisher, Ph.D.
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion:

  • Must be a primary caregiver (18 years or older) with a child between the ages of 12-36 months at study entry
  • Must live at or below 130% of the federal poverty line or receive services through foster care, TANF, SSI, or be currently homeless

Exclusion:

  • Caregiver does not have custody of their child at least half-time each week
  • Caregiver has metal implants, metal fragments, pacemaker, or other electronic medical implant
  • Caregiver is claustrophobic
  • Caregiver weighs > 550 lbs.
  • Caregiver is or thinks they may be pregnant
  • Caregiver has history of neurological disorders (e.g. twitching of the face, arms or legs; seizures)
  • Caregiver has tattoos above the neck
  • Caregiver has history of central nervous system infection (e.g. meningitis) or brain tumor
  • Caregiver has muscular or myotonic dystrophy (i.e. a condition characterized by tonic muscle spasms)
  • Caregiver has a significant visual impairment that cannot be corrected by glasses or contacts (e.g. strabismus)
  • Caregiver has history of concussion or other brain trauma
  • Caregiver is currently taking psychoactive medications (e.g. SSRIs)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Filming af interaktioner for at pleje udvikling (FIND)
FIND er en kort videocoachingintervention, som involverer feedback fra coachen til omsorgspersonen ved hjælp af korte filmklip afledt af video af omsorgsperson-barn-interaktion. Coachingen fokuserer på at vise pårørende tilfælde, hvor de engagerer sig i udviklingsstøttende interaktioner under coachingsessioner. FIND leveres over 10 ugentlige sessioner af 30-45 min. Processen begynder med en indledende session, hvor coachen giver et overblik, registrerer 10-15 minutters interaktion mellem omsorgsperson og barn og introducerer derefter begrebet tjen og tilbagevenden. Videoen er redigeret for at vise korte klip, hvor plejeren er engageret i den første af fem specifikke plejer-baserede komponenter af betjening og retur. Den næste uge gennemgår FIND-træneren de redigerede klip i detaljer med plejeren. Sessioner fortsætter, skiftende mellem filmoptagelser og coaching-sessioner, indtil alle fem komponenter er blevet dækket sekventielt.
Adfærdsmæssigt: Filming Interactions to Nurture Development
FIND is a brief home-based video coaching intervention which involves feedback provided by the coach to the caregiver using brief film clips derived from video of caregiver-child interaction collected in the home. The coaching focuses on showing caregivers instances in which they are engaging in developmentally-supportive interactions during coaching sessions. FIND is delivered over 10 weekly home visits lasting 30-45 minutes. The process begins with an initial visit in which the coach provides an overview, records 10-15 minutes of caregiver-child interaction, then introduces the concept of serve and return. The video is edited to show brief clips in which the caregiver is engaged in the first of five specific caregiver-based components of serve and return. The next week, the FIND coach reviews the edited clips in detail with the caregiver. Sessions continue, alternating between filming and coaching sessions until all five components have been covered sequentially.
Andre navne:
  • FIND
Aktiv komparator: The Healthy Toddler Program (HTP)
HTP, den aktive kontrolintervention, består af ugentlige sessioner, der veksler mellem (a) coachingsessioner, der dækker et af fem områder af børns udvikling (motorisk, kognitiv, sprog, leg og social-emotionel og (b) observationssessioner, der vil omfatte en gennemgang af den forudgående coaching session og en observation og diskussion af omsorgsperson-barn interaktionen. Denne intervention vil bestå af 10 sessioner, der hver varer 25-30 minutter. Coachen vil ikke deltage i filmoptagelser eller videocoaching, men vil være i stand til at diskutere omsorgsproblemer. HTP-materialer er tilpasset fra Partners for a Healthy Baby-pensum udviklet af Florida State Universitys Center for Forebyggelse og Tidlig Intervention Policy.
Adfærdsmæssigt: The Healthy Toddler Program
HTP, the active control intervention, consists of weekly home visits alternating between (a) coaching sessions covering one of five domains of child development (Motor, Cognitive, Language, Play, and Social-Emotional and (b) observation sessions that will include a review of the prior coaching session and an observation and discussion of the caregiver-child interaction. This intervention will consist of 10 home visits each lasting 25-30 minutes. The coach will not engage in any filming or video coaching, but will be able to discuss caregiving concerns. HTP materials are adapted from the Partners for a Healthy Baby curriculum developed by Florida State University's Center for Prevention and Early Intervention Policy.
Andre navne:
  • HTP

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Observeret niveau af hæmmende kontrol via stopsignalopgaven
Tidsramme: Ændring fra baseline ved endepunkt (3-4 måneder efter baseline)
Inhibitorisk kontrol vil blive vurderet af Stop Signal Task (SST) under en MR-scanning. Opgavehastigheden justeres baseret på ydeevne, og en enkelt responstidsscore vil blive udskrevet for hver deltager. Det centrale neurale mål er graden af ​​blodiltningsniveauafhængigt (BOLD) signal under stopforsøg i forhold til go-forsøg (dvs. "stop > go"-kontrasten over hele forsøgsperioden).
Ændring fra baseline ved endepunkt (3-4 måneder efter baseline)
Kodet hastighed af responsiv pleje via samtaledrejninger
Tidsramme: Ændring fra baseline ved endepunkt (3-4 måneder efter baseline) og 6 måneder efter endepunkt
Samtaledrejninger er et simpelt kodeskema designet til at registrere timing, mængde og længde af omsorgspersonens og børns ytringer.
Ændring fra baseline ved endepunkt (3-4 måneder efter baseline) og 6 måneder efter endepunkt
Incidence of parenting stress via the parent stress index IV
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Incidence of parenting stress via the Parent Stress Index-IV. Items are on a 5-point scale ranging from "strongly agree" to "strongly disagree." Higher scores indicated greater parenting stress.

The measures includes three subscales and a total score:

  • parental distress (12 items) sum score ranging between 12-60
  • parent-child dysfunctional interaction (12 items) sum score ranging between 12-60
  • difficult child (12 items) sum score ranging between 12-60
  • total score (36 items) sum score ranging between 36-180
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Incidence of parenting stress and child behaviors via the parent daily report
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
A caregiver self-report of the incidence of challenging child behaviors and whether the caregiver perceives the behaviors to be stressful if they are occurring.
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-reported level of perceived sense of competency
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Caregiver's perceived sense of competency in parenting via the Parent Sense of Competency scale. Items are on a 4-point scale ranging from "strongly agree" to "strongly disagree." Higher scores indicate greater parenting self-competency.

The measure includes two subscales and a total score:

  • satisfaction (9 items) with items summed into a score ranging between 9-36
  • efficacy (8 items) with items summed into a score ranging between 8-32
  • total score (18 items) with items summed into a score ranging between 18-72
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Parent Reward Task (PRT) behavior and associated brain activity
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline)
Self-reported ratings of stimuli will be used as a behavioral measure of reward (higher = better), and ventral striatum activity will be used as a measure of reward responsivity using a contrast of own child > other child.
Change from baseline at endpoint (3-4 months post-baseline)
Concentration of hair cortisol
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Cumulative HPA axis activity measured via hair cortisol concentrations (HCC)
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-reported incidence of challenging child behaviors
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-report measures of challenging child behaviors, including internalizing and externalizing behaviors, via the Child Behavior Checklist (CBCL).
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Self-reported level of social-emotional development
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

Caregiver report of their child's social emotional problems and competencies. The measure consists of 42 items that are on a 3-point scale (0=not true/rarely, 1=somewhat true/sometimes, 2=very true/always). For certain items a respondent may also respond "N" which means "no opportunity".

The measure includes two subscales:

  • problem total score (31 items) with items summed into a score ranging between 31-93; total score is compared to cut scores (age in months, gender, and cut score) to indicate if there is a possible problem. The problem total cut score is set at the 25th percentile.
  • competence total score (11 items) with items summed into a score ranging between 11-33; total score is compared to cut scores (age in months, gender, cut score) to indicate if there is a possible problem. The competency total cut score is set at the 15th percentile.
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Observed spoken language via LENA audio recordings
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
LENA is an audio recording device used to record spoken language in the natural environment. Software automatically analyzes recordings into several different metrics including estimates and percentile scores for adult words spoken to child, conversational turns, child vocalizations, and audio environment.
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Coded rate of responsive caregiving via the simple interactions scale
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

The simple interactions scale is a micro-social rating scale that assesses the quality and quantity of interaction between caregivers and their children. The scale is split into two parts: connection and reciprocity. Connection is a measure of synchrony between the caregiver-child dyad. Reciprocity is a moment-to-moment measure of serve and return interactions.

Coding for both connection and reciprocity is on a 1-3 scale (CX [1], CY [2], and CZ [3] for connections; RX [1], RY [2], and RZ [3] for reciprocity) using a flowchart and accompanying glossary of terms. Connections is rated frame by frame, while reciprocity is rated in 15-second chunks. Within Connections and Reciprocity, the X (1), Y (2), and Z (3) codes are summed and expressed as a percentage of the total video. If 20 of the 40 reciprocity time segments were coded CX, then CX = 50%. A higher percentage of Z (3) represents higher levels of connection and reciprocity in the caregiver-child interaction.
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Coded rate of responsive caregiving via the serve and return scale
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint

The Serve and Return Scale (SRS) is a global coding system used to assess responsive parenting via the FIND 5 Elements. This scale will be used to assess the quality of caregiver responsiveness and the quantity of serve and return interaction in a 10-minute video of free-play between caregivers and their children.

Items are on a 3-point scale between low, medium, and high. Higher scores indicate greater rates of responsive caregiving.

The measure includes three subscales and a total score:

  • noticing the child's serves (1 item) score ranging between 1-3
  • returning the child's serves (5 items) sum score ranging between 5-15
  • caregiver initiation (1 item) score ranging between 1-3
  • total score (7 items) sum score ranging between 7-21
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Parent Self-Evaluation Task (PSET) behavior and associated brain activity
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline)
Percentage of developmentally-supportive (DS) and developmentally-unsupportive (DU) traits endorsed under the self instruction will be used as a behavioral measure of parenting self-concept, and medial prefrontral cortex activity (mPFC) will be measured via the Self > Change contract for DS traits
Change from baseline at endpoint (3-4 months post-baseline)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Demographics
Tidsramme: Baseline
Demographic information including socioeconomic status, age and sex of caregiver and child, education level, race/ethnicity
Baseline
Incidence of early adversity
Tidsramme: Baseline
Incidence of early adversity measured via the Adverse Childhood Experiences (ACEs)
Baseline
Incidence of poor caregiver mental health
Tidsramme: Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Incidence of caregiver mental health via self-report measures of anxiety (Penn State Worry Questionnaire [PSWQ]) and depression (Center for Epidemiological Studies - Depression [CES-D]).
Change from baseline at endpoint (3-4 months post-baseline) and 6 months post-endpoint
Number of intervention sessions completed
Tidsramme: reported at end of intervention, 3-4 months post-baseline
The number of intervention sessions completed (i.e. dosage) will be assessed by the number of sessions completed by each participant. Total score will range from 0-10.
reported at end of intervention, 3-4 months post-baseline
Percentage of intervention sessions at fidelity
Tidsramme: reported at end of intervention, 3-4 months post-baseline
Percentage of the 10 total sessions that are at fidelity using a fidelity rubric.
reported at end of intervention, 3-4 months post-baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Oregon

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. oktober 2019

Primær færdiggørelse (Forventet)

31. oktober 2023

Studieafslutning (Forventet)

31. oktober 2023

Datoer for studieregistrering

Først indsendt

14. august 2019

Først indsendt, der opfyldte QC-kriterier

24. september 2019

Først opslået (Faktiske)

27. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 230949

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

All de-identified data collected from the study will be eligible for sharing externally. Audio/Video cannot be shared due to confidentiality, but data coded from these types of files will be made available.

IPD-delingstidsramme

Eligible IPD will be made available 1-year after the study is complete.

IPD-delingsadgangskriterier

IPD access requests must be approved by the study's Principal Investigator, Dr. Philip Fisher. Requests should include information about who will be given access to the IPD and what the IPD will be used for. If approved, a Data Use Agreement (DUA) will need to be completed between the University of Oregon and the institution where the IPD will be sent.

IPD-deling Understøttende informationstype

  • Studieprotokol
  • Statistisk analyseplan (SAP)
  • Formular til informeret samtykke (ICF)
  • Klinisk undersøgelsesrapport (CSR)
  • Analytisk kode

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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