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 |
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Recruitment Status :
Recruiting
First Posted : April 22, 2015
Last Update Posted : June 28, 2019
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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 |
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| Cancer |
Show Detailed Description
| 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 |
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1
Outpatients ages 8-21 enrolled in a research study either at the Pediatric Clinic or thePrimary Immune Deficiency Clinic
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Outpatients ages 8-21, receiving active cancer treatment or follow-up at Johns Hopkins, Children s Hospital Colorado, or Levine Children s Hospital
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- Positive score on depression, anxiety, pain and fatigue measures [ Time Frame: Ongoing ]Positive score on depression, anxiety, pain and fatigue measures
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
- 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.
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
| Contact: Lori Wiener, Ph.D. | (240) 760-6419 | lori.wiener@nih.gov | |
| Contact: Maryland Pao, M.D. | (301) 496-1338 | paom@mail.nih.gov |
| 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 | |
| Principal Investigator: | Maryland Pao, M.D. | National Institute of Mental Health (NIMH) |
Additional Information:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Physiological Measures Emotional Context Pediatric Distresss Screening |