A Pilot Study to Extend the K-SADS-PL to Adolescents and Young Adults

NCT01778478 | Completed

• 2 other identifiers: 13001913-M-0019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- 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. Objectives:

• 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. Eligibility:
• 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. Design:
• 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.

Conditions

Depression; Anxiety Disorder; Cancer

Keywords

Anxiety; Depression; Adolescents and Adults; Cancer Diagnosis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 years

Secondary Outcomes (2)

• Frequency of positive (threshold or subthreshold) KSADS-PL summary ratings in both groups of participants.

  2 years

• 2x2 tables and kappa statistics that describe agreement between participant responses and summary ratings.

  2 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-25 years, males and females
• English speaking
• Participant has contact (face-to-face, phone or electronic) with at least one of his/her parents at least once per week
• Enrolled in an NIH CC study (probands) or in good general health (healthy volunteers)

You may not qualify if:

• Unable to provide informed consent
• Known severe intellectual disability such as a history of mental retardation, pervasive developmental disorder or inability to complete an 8th grade education.
• Initial cancer diagnosis within the past 3 months.
• Current unstable medical condition as evidenced by Karnofsky score below 50 (for cancer patients)
• Refusal to be video or audio recorded
• Cancer that involves the brain either as primary site of cancer or as a result of metastatic disease.
• d. Description of parent participants: If there is more than one parent who is eligible, the parent who knows the participant best will be chosen. For this study, we define parent as a primary caregiver during the participant s early life who directly observed the child s development and is still alive to be interviewed. This could allow for informants who are adoptive parents or other close relatives who raised the child.
• English speaking
• Parent of a patient proband or healthy volunteer enrolled in the study
• Parent has contact (face-to-face, phone or electronic) with his/her child at least once per week
• Unable to provide informed consent
• Known severe intellectual disability such as a history of mental retardation, pervasive developmental disorder or inability to complete an 8th grade education.
• Refusal to be video or audio recorded

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Ambrosini PJ. Historical development and present status of the schedule for affective disorders and schizophrenia for school-age children (K-SADS). J Am Acad Child Adolesc Psychiatry. 2000 Jan;39(1):49-58. doi: 10.1097/00004583-200001000-00016.

  PMID: 10638067 BACKGROUND

• Birmaher B, Ehmann M, Axelson DA, Goldstein BI, Monk K, Kalas C, Kupfer D, Gill MK, Leibenluft E, Bridge J, Guyer A, Egger HL, Brent DA. Schedule for affective disorders and schizophrenia for school-age children (K-SADS-PL) for the assessment of preschool children--a preliminary psychometric study. J Psychiatr Res. 2009 Apr;43(7):680-6. doi: 10.1016/j.jpsychires.2008.10.003. Epub 2008 Nov 8.

  PMID: 19000625 BACKGROUND

• Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.

  PMID: 11832252 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Joyce Y Chung, 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: January 26, 2013
• First Posted: January 29, 2013
• Study Start: January 26, 2013
• Primary Completion: August 25, 2016
• Study Completion: May 23, 2018
• Last Updated: December 17, 2019

Record last verified: 2018-05-23

Locations

US (1)