Ethics approval and consent to participate
This trial is approved by VCU’s IRB (HM20014304). All trial conduct was performed in accordance with relevant guidelines and regulations. Families provide written consent/assent to participate in this trial after the orientation meeting in which study procedures are detailed, and eligibility confirmed. Consent and assent forms are approved by the IRB at VCU. These forms include an age-appropriate description of the study in layman’s terms, potential risks and benefits, alternative procedures (in this case, the alternative is to choose not to participate in the study), and investigator/IRB contact information. All protocol amendments are approved by VCU’s IRB prior to implementation, and are communicated to trial participants and registries as is relevant to participation. Participants’ confidentiality is protected in several ways. First, study participants are assigned a unique subject identification (SID) number and research materials are identified by SID. The key linking SID numbers and personal identifying information is kept in separate password protected file. Study charts are maintained for each participant, include the results of medical, nutritional, physical activity, and behavioral assessments, and are kept in a locked file cabinet in secure, locked data management facilities. The study database is password-protected and maintained at VCU on a secure server behind a firewall. Audiotapes of sessions are not transcribed, and no participants’ names or identifying information are included in treatment fidelity monitoring, minimizing the potential for breach of confidentiality. These recordings are maintained on the secure, password protected server, to which only appropriate study personnel have access. All study staff are required to maintain data in compliance with the Health Insurance Portability and Accountability Act. This law includes standards for the protection of identifiable health information. In addition, all study staff are required to complete the Collaborative Investigator Training Initiative course in human subjects’ protection offered by VCU’s Office of Research Subjects Protection.