The Child and Adolescent Mood Disorders Task Group was formed in light of the special considerations needed when working with mood disorder patients under the age of 18. While this demographic can present unique challenges, the reward in helping children overcome emotional and mental adversities is enormous. During meetings the Task Group reviews the latest research in the field of child psychiatry, shares clinical advice, and discuses collaborative project ideas.
CAMD – Sample IRB Application
Institutional Review Board Application
NNDC-Adolescent Mood Outcomes Program Feasibility Study
The National Network of Depression Centers (NNDC) is a consortium of 22 academic medical centers of excellence around the country providing care for patients with mood disorders, including depression and bipolar disorder. The goal of the NNDC is improve the lives of patients with these disorders through advances in clinical care, research and education. In an effort to improve the quality of care, the NNDC has established the Mood Outcomes Program (MOP), in which the clinical progress of adult patients is carefully monitored over time at each of the participating clinics, using 4 standardized patient self-report questionnaires. The NNDC now wishes to assess the feasibility and utility of using this program in younger patients (ages 12-17) at the 15 NNDC sites that treat children and adolescents.
In the current MOP, adult patients (age 18 and older) are asked to complete four standardized self-report forms at each clinical visit that measure depression (Patient Health Questionnaire, or PHQ-9), anxiety (Generalized Anxiety Disorder 7-item Scale, or GAD-7), suicidality (Columbia Suicide Severity Rating Scale, or C-SSRS) and mania (Altman Self-Rated Mania Scale, or Altman). Forms are completed either on kiosk computers or tablets in clinic waiting rooms. The NNDC has partnered with a non-profit health informatics organization, Altarum Institute, to manage the data from this clinical care program. The questionnaires and answers are encrypted and secure in a HIPAA-compliant electronic environment.
All of the measures (PHQ-9, GAD-7, C-SSRS and Altman) are part of standard-of-care practice and clinicians can view the results in real-time, in graphs that include any previous results from prior patient visits, as a way of assessing current symptoms and previous symptoms. This information can then be used to help guide treatment decisions and assess patient progress.
Thus far, the MOP has only been administered to adult patients. The current study hopes to learn how acceptable and useful these measures are to both adolescent patients and their clinicians.
Aim of This Study
In this proof-of-concept study, we will: 1) summarize clinician evaluations of the NNDC battery in the one current clinic where the adult battery is currently being administered to adolescents; 2) determine patient and clinician level of interest in using the NNDC battery in clinics where the adult battery is not currently being administered to adolescent patients (n=14); 3) measure change in evaluation 3 months post-implementation for any sites that begin administering the NNDC battery to adolescents; and 4) generate potential new Child and Adolescent Mood Disorders Interest Group (CAMDIG) research protocols for future consideration.
Quantitative and qualitative data will be obtained via surveys administered at the 15 NNDC sites with adolescent clinics. Specifically, all clinicians at the 15 sites (approximately N=125), a random sampling of 10 patients each at the 14 sites that are not currently using the NNDC battery (N=140), a random sampling of 50 patients at the 1 site currently using the NNDC battery, and site PIs (N=15) will be surveyed.
Results from this study are anticipated to: 1) prompt more of the 14 NNDC adolescent clinic sites not currently utilizing the MOP to engage partially or fully in the NNDC MOP with adolescent patients; 2) guide recommendations for the NNDC regarding steps that could be taken to further increase site participation (e.g., providing resources to include different or additional measures); and 3) generate interest in developing research protocols using shared assessment protocols across sites.
Participants and Procedures
Participants in the study include clinicians and patients at each site. The NCH site will seek to enroll as many child and adolescent providers as possible (max=12) who work at the Mood and Anxiety Program, and 10 patients who meet eligibility criteria as described below. The national goal for the study is to yield approximately 125 clinician surveys and approximately 190 patient surveys. The local study coordinator will keep a record of the number of study refusers (both clinicians and patients) at the NCH Mood and Anxiety Program.
All clinicians at each site who treat child and adolescent patients are eligible to participate. Upon receipt of IRB approval, the study coordinator will approach all eligible clinicians to assess interest in participation. The study coordinator will then explain the study, which involve completing two instruments, described below, and offer participation to all interested clinicians. Clinicians will be offered a $5 gift card for study participation.
Clinician surveys include only the clinician’s age in years, gender (male, female, other), the site code and the date the questionnaire was completed. The form also includes a participant number (1 through 12) but there is no link between the clinician and the participant number; it is used only to track how many forms have been completed. Thus, no Protected Health Information (PHI) will be collected.
The Mood Outcomes Program Clinician Survey is a 24-item survey that is a slightly modified version of a Feedback Questionnaire developed by Willis and colleagues (2009). The survey will be accompanied by copies of the NNDC MOP questionnaires. Survey questions were rewritten as needed to reflect the specific NNDC battery rather than outcome measures in general, and to consistently refer to “patients” rather than “consumers/clients.” The survey includes 23 questions about utilization of outcome measures with patients. Forced response choices appear on a 1-6 Likert-scale (1=strongly disagree; 6 = strongly agree). Following these 23-items is a prompt to provide additional qualitative commentary, including suggestions for cross-site studies if a common outcome database were to be established.
The Study Ideas Survey is 4-item survey that provides an opportunity for clinicians to comment on 1) study ideas that could be implemented with the entire NNDC battery or, 2) with a partial NNDC battery, 3) specify the site/sample size needed to make data collection worthwhile; and 4) generate suggestions for modifications of the CAMDIG MOP.
The study coordinator will explain the study and offer study participation to consecutive patients who have regularly scheduled clinic visits and who meet eligibility criteria, until 10 patient surveys (50 at the Johns Hopkins site) have been collected. Patients will be offered $2 for study participation. Patient eligibility criteria include:
- English speaking;
- Between the ages of 12-17;
- Patient self-report of having a mood disorder (high likelihood as he/she is being treated in an adolescent mood clinic);
- The child and legal guardian(s) are able and willing to give written informed assent/consent to participate.
The patient survey collects the patient’s age in years, gender (male, female, other), the site code and the date the questionnaire was completed. The form also includes a participant number (1 through 10) but there is no link between the patient and the participant number; it is used only to track how many forms have been completed. Thus, there is no Protected Health Information (PHI) on the form.
The Mood Outcomes Program Adolescent Survey is a 16-item survey informed by the clinician survey and tailored to collect feedback from adolescent outpatient participants regarding their thoughts about self-reported outcome measures (Miller, 2018) (“e.g., I feel comfortable filling out questions about how I am feeling”). It will be accompanied by copies of the NNDC battery (PHQ-9, GAD-7, C-SSRS and Altman) for the patient to review.
Following completion of data collection at each site, surveys will be scanned and emailed to the Central Data Site at OSU. Site PIs will receive copies of the summarized results from their site and the overall study.
Currently, one adolescent site (JHU) uses the NNDC battery. If additional sites adopt the battery prior to beginning the survey, their data will be analyzed with the JHU site (utilizer group). The remaining sites’ data will be analyzed together (non-utilizer group). Descriptive statistics will be used to summarize the survey data; themes in the clinician open-ended responses will be categorized and potential study ideas will be collated. T-tests will be used to compare scores between the utilizer and non-utilizer groups as well as pre/post changes for any sites that begin utilization during the study.
Miller, L. (2018). Consumer survey of self-rated outcomes. Unpublished questionnaire, Johns Hopkins University, Baltimore, MD.
Willis, A., Deane, F. P., & Coombs, T. (2009). Improving clinicians’ attitudes toward providing feedback on routine outcome assessments. International Journal of Mental Health Nursing, 18, 211-215.