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Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT01799291
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE February 24, 2013
First Posted Date  ICMJE February 26, 2013
Last Update Posted Date April 25, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2013)
Diagnostic accuracy [ Time Frame: one time, immediately following Web-based presentation(s) ]
Participants in treatment and control conditions report vignette characters' probable diagnoses after reading each vignette. These diagnoses were rated on a 3-point Likert scale of (1 = inaccurate diagnosis, 2 = somewhat accurate, and 3 = accurate diagnosis) using criteria established by the research team (which includes expert diagnosticians).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2013)
Clinician attitudes toward intervention [ Time Frame: one time, immediately after Web-based intervention ]
Participants in the treatment group complete a brief questionnaire (4 items) about their attitudes toward the cognitive de-biasing intervention. This measure describes different aspects of the intervention (e.g., how helpful it was in making diagnostic decisions), and requires participants to make ratings on a 6-point scale: (1) strong agree; (2) agree; (3) somewhat agree; (4) somewhat disagree; (5) disagree; and, (6) strong disagree.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder
Official Title  ICMJE Decision Making and Mental Health: Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder
Brief Summary The primary aim is to test the efficacy of a new intervention to improve clinical judgment. The investigators focus on the assessment of pediatric bipolar disorder (PBD), a controversial diagnosis with frequent diagnostic errors, by educating mental health professionals in common cognitive pitfalls and training them in recommended de-biasing strategies. The investigators hypothesize that the Treatment group will show higher diagnostic accuracy than the Control condition: Participants receiving the cognitive de-biasing intervention will be less likely to commit faulty heuristics and race/ethnicity bias. Secondary aims include soliciting feedback about whether the skills were useful when diagnosing the vignettes, and whether skills and cases seem clinically realistic.
Detailed Description

A randomized controlled trial (RCT) of 100 participants will test the efficacy of a new intervention to improve clinical judgment.

Eligible participants will be licensed or currently supervised by a licensed mental health professional and have experience working with pediatric populations.

Participants will be randomly assigned to either Treatment or Control conditions. All participants receive a 5 minute pre-recorded presentation about mood disorders, then read several case vignettes and respond to questions regarding judgments about probable diagnoses and next clinical actions.

Study administration is Web-based via a secure portal. After answering questions to confirm eligibility and provide informed consent, participants will complete a background questionnaire. The Web software, Qualtrics, will randomize participants to watch a brief presentation on mood disorders (i.e., Control condition) versus the same presentation on mood disorders combined with the intervention (i.e., Treatment condition). The intervention is a 20-minute training on decision-making errors and cognitive de-biasing strategies.

Next, all participants review four clinical vignettes. Using only four vignettes reduces participant burden and maximizes response rate. Qualtrics presents the case vignettes in random orders.

After completing the last vignette and corresponding questions, participants in the treatment condition rate their experience of the intervention. These questions address the secondary study aims: (a) how participants will use these new techniques in their clinical practice; and, (b) how the investigators can tailor the intervention to make it even more user-friendly and appealing to clinical audiences.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Decision Making
  • Bipolar Disorder
Intervention  ICMJE Behavioral: Decision Making Tutorial
A web-based presentation focused on key "cognitive de-biasing" strategies, including helping clinician participants: consider alternative diagnoses (e.g., symptom checklists); decrease reliance on memory (e.g., mnemonics); and incorporate Bayesian reasoning (e.g., actuarial approaches).
Study Arms  ICMJE
  • Treatment: Decision Making Tutorial
    A brief presentation on mood disorders (i.e., Control condition) combined with the intervention (i.e., Treatment condition): a 20-minute training on decision-making errors and cognitive de-biasing strategies.
    Intervention: Behavioral: Decision Making Tutorial
  • No Intervention: Control
    A brief presentation about mood disorders.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2013)
240
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2013)
100
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants need to be: (a) licensed or currently supervised by a licensed mental health professional; and, (b) have experience treating child and adolescent patient populations for mental health issues.

Exclusion Criteria:

  • Not meeting criterion (a) or (b) above.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01799291
Other Study ID Numbers  ICMJE 2KR401204-MMJ
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE North Carolina Translational and Clinical Sciences Institute
Investigators  ICMJE
Principal Investigator: Melissa M Jenkins, M.A. University of North Carolina, Chapel Hill
Study Chair: Eric A Youngstrom, Ph.D. University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP