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


N/A
18 Years
80 Years
Open (Enrolling)
Both
Depression, Anxiety Disorder, Cancer

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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.

Inclusion Criteria


- a. Description of proband patients and healthy volunteers: these adult participants
between the ages of 18-25 will be invited to undergo a psychiatric diagnostic
interview using the K-SADS - PL. Current or past history of mental health problems or
treatment is allowed.

b. Proband patient/healthy volunteer inclusion criteria

- 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 oncology study (probands) or in good general health (healthy
volunteers)

c. Proband patient/healthy volunteer exclusion criteria

- 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

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.

e. Parent participant inclusion criteria

- 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

f. Parent participant exclusion criteria

- 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

2 years

Principal Investigator

Joyce Y Chung, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Mental Health (NIMH)

Authority:

United States: Federal Government

Study ID:

130019

NCT ID:

NCT01778478

Start Date:

November 2012

Completion Date:

August 2014

Related Keywords:

  • Depression
  • Anxiety Disorder
  • Cancer
  • Anxiety
  • Depression
  • Adolescents and Adults
  • Cancer Diagnosis
  • Anxiety Disorders
  • Depression
  • Depressive Disorder

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892