BACKGROUND: The aim of the present study was to test the possibility to apply habit reversal training (HRT) in Italy and to evaluate the effectiveness of HRT in reducing tic severity compared with the "usual care" (UC) in Italian children and adolescents with Tourette Syndrome. METHODS: We performed a single blind, randomized, pilot study comparing HRT (active treatment) and UC (usual treatment). Out of 69 patients seen during the study period, we were able to enroll 21 patients (11 randomized to HRT e 10 to UC). Assessment included in-depth neurological and psychiatric examination, K-SADS-PL, YGTSS, KIDSCREEN, GTS-QOL, CGI and C-GAS. All these evaluations but the K-SADS-PL were used for baseline assessment but also one week after the end of treatment (T1) and then 3, 6 and 9 months later (respectively T2, T3, and T4). RESULTS: The sample was largely composed of patients of relevant clinical severity (CGI≥3: 85%). OCD and ADHD were the most frequent comorbidities (30% each). Only minor differences in terms of treatment effectiveness were found, although the HRT group turned out to include patients with more tics and a more compromised general functioning despite randomization. CONCLUSIONS: We had a high number of patients who refused to be randomized (23 out of 69) and a high number of drop outs (27% in the HRT group, 50% in the UC group). There was an improvement in terms of reduced tics and improved global functioning in both groups, without significant changes in terms of Quality of Life.
RCT Entities:
BACKGROUND: The aim of the present study was to test the possibility to apply habit reversal training (HRT) in Italy and to evaluate the effectiveness of HRT in reducing tic severity compared with the "usual care" (UC) in Italian children and adolescents with Tourette Syndrome. METHODS: We performed a single blind, randomized, pilot study comparing HRT (active treatment) and UC (usual treatment). Out of 69 patients seen during the study period, we were able to enroll 21 patients (11 randomized to HRT e 10 to UC). Assessment included in-depth neurological and psychiatric examination, K-SADS-PL, YGTSS, KIDSCREEN, GTS-QOL, CGI and C-GAS. All these evaluations but the K-SADS-PL were used for baseline assessment but also one week after the end of treatment (T1) and then 3, 6 and 9 months later (respectively T2, T3, and T4). RESULTS: The sample was largely composed of patients of relevant clinical severity (CGI≥3: 85%). OCD and ADHD were the most frequent comorbidities (30% each). Only minor differences in terms of treatment effectiveness were found, although the HRT group turned out to include patients with more tics and a more compromised general functioning despite randomization. CONCLUSIONS: We had a high number of patients who refused to be randomized (23 out of 69) and a high number of drop outs (27% in the HRT group, 50% in the UC group). There was an improvement in terms of reduced tics and improved global functioning in both groups, without significant changes in terms of Quality of Life.