Trial Information

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

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.