The purpose of this study is to investigate the treatment sensitivity of the multi-item DBR scales (a hybrid between rating scales and direct observation) (henceforth referred to as "DBR-MIS'') through a series of single-case intervention studies. That is, we wish to examine whether the DBR-MIS measures are sensitive to changes in student behavior. The single-case studies will use an A-B design across subjects to evaluate the effects of medication intervention on internalizing behaviors ( e.g., worries, sad), social behaviors (e.g., reluctant to join others, avoidant), and externalizing behaviors (e.g., disruptive, oppositional). It is hypothesized that changes in these behaviors will be reflected in the DBR-MIS ratings completed by classroom teachers and the students themselves (if age 8 and above). Secondary aims include looking at teacher and student concordance on the DBR-MIS measures in the instances when both the teacher and the student ( of appropriately determined age) will be completing the brief rating scales.
- Elementary-age students
- Receiving medication treatment at Tufts MC
- Children who will not be receiving medication treatment at Tufts MC
- Children not experiencing any internalizing concerns (e.g. worry, sadness, etc.)
- Non-English speakers
10 elementary-aged students (age 5-12 years old) will be recruited during intake procedures at the Center for Children with Special Needs within the Developmental-Behavioral Pediatrics Department at Tufts Medical Center (current patient population). The Principal Investigator will identify if children are eligible to participate if they are (a) presenting with concerns related to anxiety and/or depression and (b) seeking medication treatment. This recruitment method will be effective in attracting the targeted subject population as they will already be seeking evaluation and treatment for the primary concerns that this study seeks to address.
Parents will be approached by the research coordinator during intake and asked to participate in the research study (see attached consent form). If the parent provides consent, he/she will also be able to provide contact information (e.g. school, name, email, telephone number) of the child's primary teacher. During intake, the research coordinator will also obtain child assent (see attached assent form). This will all occur in a private space in the Department of Developmental-Pediatrics. Following parental consent and student assent, the corresponding childrens' teachers will be contacted via phone or email by the Research Coordinator and asked to participate in the research study by completing daily behavior ratings (see attached teacher consent form). The attached consent and assent forms illustrates the information provided to each participant.
After receiving parent and teacher consent ( and student assent if completing self-report ratings), the research team will identify which DBR-MIS scales are best aligned with the child's presenting problems (as identified through the intake at Tufts). These scales can be found in the document attached to this application entitled "Final DBR_MIS Scales & Items." Teachers will then be trained (through the attached document entitled "iFAB Online - Steps for Rating") to use a simple and secure web-based platform to complete the DBR-MIS scales once at the end of each school day. An automatic email reminder to complete the ratings and a link to access the scales will be sent to the teacher in the afternoon (prior to the end of the school day). Each teacher will be assigned an identification number and no identifying information about students or teachers will be entered. A document listing each DBR-MIS scale is attached; however, it is important to note each teacher will only complete 2-3 of the following DBR-MIS depending on the behaviors exhibited by the student. As each DBR-MIS consists of roughly 5 items, each daily assessment should therefore take no more than 2-3 minutes.
If students are age 8 or older, they will also be asked to complete the same DBR-MIS scales that their teachers are rating in order to examine the consistency between teacher and child report. The child will therefore be instructed how to complete the ratings online each day ( document "iFAB Online - Steps for Rating) and can also elect to have an email reminder sent to him/herself or a parent's email address. The Research Coordinator will explain this process and show children and parents (when applicable) how to use the iFAB Online system during intake.
The goal is to have at least 3 days (3 ratings) of baseline data (Phase "A" in the A-B design) collected per child before moving into the treatment phase; however, this study will not affect when medication is introduced by the clinicians at Tufts. This study will in no way affect treatment as usual; it is only observational through survey data. After the child begins medication, DBR-MIS ratings will continue to be completed (this will be the start of Phase "B" in the A-B design) until a treatment effect is observed. The above procedures are all directly related to providing data for the research, but will not affect usual standard of care provided by Tufts Medical Center.
It is estimated that it will take approximately 2-3 months to emoll all study participants at Tufts MC. Because it often takes many weeks for medication to have effects, participants will be asked to complete the DBR-MIS scales for many weeks until a change has been documented ( approximately 5-10 weeks).
There will only be one "study visit" in which parent and child consent and assent will be obtained. Information will be provided verbally about the online rating system and then ratings will be completed independently at home.