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Sponsor study identifier
Secondary identifiers
observational
289
1 country
1
Study Start
January 13, 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
May 31, 2018
Date type not reportedThis date has not been verified as actual or estimated.
Medical illnesses and treatments can cause distress in patients, and medical professionals are very interested in identifying distress quickly to ensure that a patient can receive appropriate support and treatment. Adult patients often use a screening tool known as the Distress Thermometer to indicate the causes and levels of distress they feel. However, little work has been done on how to assess distress in pediatric patients. This study will investigate the effectiveness of the Distress Thermometer as a tool to accurately measure distress in pediatric patients, and determine whether primary caregivers and physicians can also use the Distress Thermometer to accurately gauge a patient s levels and sources of distress. The study will also investigate the effectiveness of the Distress Thermometer compared with other means of measuring fatigue, mood, and pain levels. This study will include approximately 90 patients between 7 and 21 years of age who are currently enrolled in a National Institutes of Health pediatric research study. It will also include responses from the primary caregivers and primary medical providers of the patients involved in the study. All patients will complete the Distress Thermometer s self-reported distress scale and other standardized measures of anxiety, depression, fatigue, and pain. In addition, patients between 18 and 21 years of age will be asked to assess the benefits and negative effects of participating in psychosocial research. On the same day, the patient s primary caregiver and primary medical provider will complete a Distress Thermometer survey to estimate the patient s distress level. If either the patient or the primary caregiver indicate high levels of distress or mood symptoms, the researchers will offer them an opportunity to speak with a mental health professional. The primary medical provider will also receive a copy of the responses reported on the patient s Distress Thermometer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2018
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 13, 2009
Date type not reportedThis date has not been verified as actual or estimated.
January 15, 2009
Actual (reported)January 16, 2009
Actual (reported)May 31, 2018
Date type not reportedThis date has not been verified as actual or estimated.
Positive score on depression, anxiety, pain and fatigue measures.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Allison TG, Williams DE, Miller TD, Patten CA, Bailey KR, Squires RW, Gau GT. Medical and economic costs of psychologic distress in patients with coronary artery disease. Mayo Clin Proc. 1995 Aug;70(8):734-42. doi: 10.4065/70.8.734.
Barton B, North K. Social skills of children with neurofibromatosis type 1. Dev Med Child Neurol. 2004 Aug;46(8):553-63. doi: 10.1017/s0012162204000921.
Battles HB, Wiener LS. From adolescence through young adulthood: psychosocial adjustment associated with long-term survival of HIV. J Adolesc Health. 2002 Mar;30(3):161-8. doi: 10.1016/s1054-139x(01)00341-x.
Maryland Pao, M.D.
National Institute of Mental Health (NIMH)
289 participants (actual enrollment reported by the registry).
First Submitted
January 15, 2009
First Posted
January 16, 2009
Study Start
January 13, 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Shain LM, Pao M, Tipton MV, Bedoya SZ, Kang SJ, Horowitz LM, Wiener L. Comparing Parent and Child Self-report Measures of the State-Trait Anxiety Inventory in Children and Adolescents with a Chronic Health Condition. J Clin Psychol Med Settings. 2020 Mar;27(1):173-181. doi: 10.1007/s10880-019-09631-5.
Wiener L, Battles H, Zadeh S, Pao M. Is Participating in Psychological Research a Benefit, Burden, or Both for Medically Ill Youth and Their Caregivers? IRB. 2015 Nov-Dec;37(6):1-8.
Study Completion
May 31, 2018
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
December 17, 2019
Record last verified: 2018-05-31
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Source: ClinicalTrials.gov.
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