A Pilot Study to Extend the K-SADS-PL to Adolescents and Young Adults
- An interview called the Schedule for Affective Disorders and Schizophrenia for School Age Children Present and Lifetime version (K-SADS-PL) is used to identify mental health problems among children and younger teens. Both the child and a parent are asked questions about the child s behaviors and symptoms that might indicate such problems. Researchers want to see if the K-SADS-PL can help identify mental health problems in young adults (ages 18 to 25). Two groups of young adults, including healthy volunteers and people with cancer, and their parents will participate in this study.
- To see if the K-SADS-PL interview used for children and teens can also be used for young adults.
- To see whether information provided by parents will affect the rate of mental health problems found.
- Individuals aged 18-25 years who have cancer and are participating in research studies at the National Institutes of Health.
- Healthy volunteers aged 18-25 years.
- A parent of a young adult who is participating in this study.
- This study requires one study visit that includes an interview and self-report questionnaires. It will take about 1 to 3 hours. A follow-up phone call or visit will also be required.
- Young adult participants will be given the K-SADS-PL interview and four questionnaires that ask about mood, anxiety, distress, parental contact, and development during childhood. The K-SADS-PL interview will be video recorded or audio recorded.
- Parents will also be given the K-SADS-PL interview. This interview can be done in person or by phone, and will also be recorded.
- No treatment will be provided as part of this study.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pilot Study to Extend the K-SADS-PL to Adolescents and Young Adults|
- Feasibility defined in the 18-25 year old cancer patient group as a completion rate of greater than or equal to 60 percent among those approached to enter the study. [ Time Frame: 2 years ]
- Feasibility in parents is greater than or equal to 80 percent completion rate of the parent portion of the K-SADS-PL interview. [ Time Frame: 2 years ]
- Frequency of positive (threshold or subthreshold) KSADS-PL summary ratings in both groups of participants. [ Time Frame: 2 years ]
- 2x2 tables and kappa statistics that describe agreement between participant responses and summary ratings. [ Time Frame: 2 years ]
|Study Start Date:||November 7, 2012|
|Study Completion Date:||August 25, 2016|
|Primary Completion Date:||August 25, 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778478
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Joyce Y Chung, M.D.||National Institute of Mental Health (NIMH)|