An observational study in Depression, Anxiety Disorder and Cancer, sponsored by National Institute of Mental Health (NIMH). Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-12-17.
Sponsored by National Institute of Mental Health (NIMH) · Observational
Background:
Objectives:
Eligibility:
Design:
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 50 is below the median of 160 across 1,084 observational studies indexed under Depression.
Browse Depression studies →National Institute of Mental Health (NIMH) is the lead sponsor of 359 studies on the registry; 46 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Enrolled in an NIH CC study (probands) or in good general health (healthy volunteers)
c. Proband patient/healthy volunteer exclusion criteria
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
Parent has contact (face-to-face, phone or electronic) with his/her child at least once per week
f. Parent participant exclusion criteria
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.
Time frame: 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.
Time frame: 2 years
Frequency of positive (threshold or subthreshold) KSADS-PL summary ratings in both groups of participants.
Time frame: 2 years
2x2 tables and kappa statistics that describe agreement between participant responses and summary ratings.
Time frame: 2 years
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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National Institute of Mental Health (NIMH)