Pilot Study to Extend the K-SADS-PL to Adolescents and Young Adults
Data Collection
Collected from today forward - ProspectiveAnxiety Disorders+3
+ Behavior
+ Mental Disorders
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 26, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 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 * 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. 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps