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

NCT02423031 | Completed

• 2 other identifiers: 15010915-M-0109
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 4

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.

Conditions

Cancer

Keywords

Physiological Measures; Emotional Context; Pediatric; Distress Screening; Natural History

Outcome Measures

Primary Outcomes (1)

• Positive score on depression, anxiety, pain and fatigue measures

  Positive score on depression, anxiety, pain and fatigue measures

  Ongoing

Study Arms (2)

Caregivers

caregivers of pediatric patients with cancer and other serious illnesses

pediatric patients

pediatric patients with cancer and other serious illnesses

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pediatric cancer patients

You may qualify if:

• 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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You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (4)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Carolinas Medical Center Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms

Study Officials

• Maryland Pao, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2015
• First Posted: April 22, 2015
• Study Start: April 14, 2015
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

US (4)