Regulating Together A Remote Behavioral Therapy Program for Children and Adolescents Aged 8 to 17 with Tuberous Sclerosis Complex and Neuropsychiatric Symptoms

What this Trial Is About

Researchers are evaluating a remote, non-drug program called Regulating Together RT to help children and adolescents with Tuberous Sclerosis Complex TSC and related neuropsychiatric challenges manage symptoms of emotion dysregulation. The study focuses on improving emotional control in young participants aged 8 to 17 years with behavioral symptoms linked to TSC. This pilot feasibility trial includes children diagnosed clinically or genetically with TSC who show behavioral issues such as temper tantrums, aggression, self-injury, or impulsivity. The study consists of several phases over 22 weeks. It starts with a single in-person screening and baseline visit, followed by a 5-week control phase without intervention. Then, participants receive an intensive RT program involving small group behavioral therapy sessions twice a week for 5 weeks, conducted remotely by trained psychologists. Caregivers attend separate but parallel sessions. After this, there is a one-time individualized consultation with a psychologist. Finally, participants practice the learned skills at home during a 10-week follow-up, ending with a final interview to explore factors affecting the intervention. Throughout the study, parents complete assessments measuring emotional and behavioral changes at each phase, including tools like the Emotion Dysregulation Inventory and other behavior rating scales. The study team measures changes in emotional dysregulation from baseline through intervention and follow-up. Participants need access to video-capable devices and internet for remote sessions. Researchers monitor progress through questionnaires, interviews, and behavioral observations, aiming to understand how well the RT program supports emotional regulation in children with TSC.

Regulating Together in Tuberous Sclerosis Complex