A Pilot Study to Extend the K-SADS-PL to Adolescents and Young Adults
Condition: Depression; Anxiety Disorder; Cancer
MeSH terms: Depression; Anxiety Disorders
Study type: Observational

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.
    

Detailed description: 
      Objective:

      The goal of this pilot project is to describe the feasibility of using the Schedule for
      Affective Disorders and Schizophreni\a for School Age Children Present and Lifetime Version
      (K-SADS-PL) to screen and evaluate older adolescents and young adults (ages 18-25) for mood
      and anxiety disorders. An additional aim is to describe the contribution of the parent
      interview portion of the instrument for this age group. Two groups of 18-25 year old
      participants will be enrolled: healthy volunteers and patients with cancer. The information
      gained in this pilot study will inform the design of future intervention studies that target
      mood and anxiety disorders among pediatric oncology patients.

      Primary aim:

      Aim 1: Feasibility - Describe the feasibility of using the K-SADS-PL interview to screen and
      evaluate for mood and anxiety disorders among two groups of 18 25 year olds (healthy
      volunteers and patients with cancer) and their parents.

      Hypothesis 1: The K-SADS-PL interview is feasible to use in the two groups of 18 25 year
      olds; the feasibility of completing the parent portion of the K-SADS-PL will be better among
      parents of cancer participants compared to parents of healthy volunteers.

      Secondary aim:

      Aim 2: K-SADS-PL outcomes - Compare and contrast K-SADS-PL findings based on responses
      provided by participants versus summary ratings that take into account both parent and child
      responses.

      Hypothesis 2: Summary ratings of K-SADS-PL screening and diagnostic questions will yield more
      positive screening findings (subthreshold or threshold) compared to participant ratings
      alone.

      Study population

      This pilot study will include a convenience sample of young adults, aged 18-25, from two
      groups healthy volunteers and individuals who are participants in oncology protocols at the
      NIH Clinical Center (inpatient or outpatient) and who agree to participate. Participants may
      be from any institute, but must have a parent who will agree to be interviewed.

      Design

      This is a pilot study to describe the feasibility of extending the K-SADS-PL diagnostic
      interview to screen and evaluate young adults 18-25 years of age for psychiatric disorders.
      Informed consent will be obtained from the participant and his/her parent. The interview will
      be administered by a interviewer trained to administer the K-SADS-PL instrument. The same
      interviewer will administer the K-SADS-PLL to both the participant and the parent. The
      participant will be interviewed first, and the parent second. If there is more than one
      parent who is eligible, the parent who knows the participant best will be chosen. All
      interviews will be recorded. A subset of interview recordings will be randomly rated by a
      gold standard expert rater to determine inter-rater kappa coefficients for screening and
      diagnostic questions about mood and anxiety disorders.

      Availability of parents to complete the K-SADS-PL interview will be optimized by allowing
      either face-to-face or phone interviews. If a parent interview reveals clinically significant
      information that the participant did not report, the interviewer will re-contact the
      participant to complete the necessary diagnostic module. Summary screening and diagnostic
      ratings will be determined by the interviewer, taking into account both participant and
      parent responses as per the K-SADS-PL design.

      We will also ask participants to complete several short questionnaires:1) Hospital Anxiety
      and Depression Scale (HADS); 2) Parent-child frequency of contact; 3) Distress Thermometer;
      4) Course of Life questionnaire.
    

Observational model: Cohort
Time perspective: Prospective
Keywords: Anxiety; Depression; Adolescents and Adults; Cancer Diagnosis