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Checking Out Checking In: The Development and Validation of an Electronic Screening Tool for Pediatric Psychosocial Distress

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ClinicalTrials.gov Identifier: NCT02423031
Recruitment Status : Recruiting
First Posted : April 22, 2015
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Brief Summary:

Background:

- Medical problems and treatments can cause stress in some people. Researchers want to learn more about how to measure distress in young people with medical illnesses. A screening tool called Checking In will be developed in order to help researchers find ways to identify concerns and stresses common to this group.

Objective:

- To create a screening tool that will help health care providers identify psychological and social distress in young people with serious illnesses.

Eligibility:

- Outpatient youth ages 8 21 who are enrolled on a research protocol at the NIH at the time of the study.

Design:

  • Phase 1 participants will complete a paper-and-pencil version of Checking In. It asks about mood, pain, fatigue, peer relationships, and sleep. During this phase, participants will be asked about the wording of the questions in Checking In. They will also talk about what they thought of the questions and if they understood them.
  • Phase 2 will not involve participant enrollment. During this phase the researchers will be working with technologists to develop the software for an electronic version of Checking In.
  • Phase 3 participants will complete an electronic version of Checking In. Researchers will ask questions about the ease or difficulty of using an electronic screen.
  • Phase 4 participants and one of their caregivers will complete an electronic version of Checking In. They will also complete other questionnaires related to mood, pain fatigue, peer relationships and sleep. They will be asked their thoughts about using Checking In. On the same day, their NIH doctor will get summary data about their questionnaire answers. The doctor will also provide feedback about the summary form.
  • Researchers will compare data from Checking In with data from the other questionnaires.

Condition or disease
Cancer

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Checking Out Checking In: The Development and Validation of an Electronic Screening Tool for Pediatric Psychosocial Distress
Actual Study Start Date : October 5, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : August 8, 2025

Group/Cohort
1
Outpatients ages 8-21 enrolled in a research study either at the Pediatric Clinic or thePrimary Immune Deficiency Clinic
2
Outpatients ages 8-21, receiving active cancer treatment or follow-up at Johns Hopkins, Children s Hospital Colorado, or Levine Children s Hospital



Primary Outcome Measures :
  1. Positive score on depression, anxiety, pain and fatigue measures [ Time Frame: Ongoing ]
    Positive score on depression, anxiety, pain and fatigue measures



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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria
  • INCLUSION CRITERIA:
  • Age 8 to 21 years.
  • Must be enrolled in a research protocol at the NIH or receiving cancer treatment or follow-up care at Johns Hopkins, Children s Hospital Colorado, or Levine Children s Hospital and be an outpatient at time of study. The treatment protocol PI will be contacted before a patient is approached to ensure that the patient is appropriate for enrollment into this protocol.
  • Must have a parent/guardian available to complete the study measures.
  • Patients and caregiver must be be able to read in English and write in English (as all instruments have not been validated in other languages)

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EXCLUSION CRITERIA:

-Patients can be excluded from this study if there is a presence of psychotic symptoms or cognitive impairment, which in the judgment of the Principal or Associate Investigator, or consulting psychiatrist would compromise the patient s ability to accurately complete the measures.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423031


Contacts
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Contact: Lori Wiener, Ph.D. (240) 760-6419 lori.wiener@nih.gov
Contact: Maryland Pao, M.D. (301) 496-1338 paom@mail.nih.gov

Locations
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United States, Colorado
Children s Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Robert Casey    720-777-6594    Robert.casey@childrenscolorado.org   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Kathy Ruble    410-614-5062    rubleka@jhmi.edu   
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Amii Steele    704-381-9966    Amii.Steele@atriumhealth.org   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Maryland Pao, M.D. National Institute of Mental Health (NIMH)

Additional Information:
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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT02423031     History of Changes
Other Study ID Numbers: 150109
15-M-0109
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 25, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Physiological Measures
Emotional Context
Pediatric
Distresss Screening