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BACKGROUND: Emotional behavior problems (EBP) are the most common and persistent mental health issues in early childhood. Early intervention programs are crucial in helping children with EBP. Parent-child interaction therapy (PCIT) is an evidence-based therapy designed to address personal difficulties of parent-child dyads as well as reduce externalizing behaviors. In clinical practice, parents consistently struggle to provide accurate characterizations of EBP symptoms (number, timing of tantrums, precipitating events) even from the week before in their young children. The main aim of the study is to evaluate feasibility of the use of smartwatches in children aged 3-7 years with EBP. METHODS: This randomized double-blind controlled study aims to recruit a total of 100 participants, consisting of 50 children aged 3-7 years with an EBP measure rated above the clinically significant range (T-score ≥ 60) (Eyberg Child Behavior Inventory-ECBI; Eyberg & Pincus, 1999) and their parents who are at least 18 years old. Participants are randomly assigned to the artificial intelligence-PCIT group (AI-PCIT) or the PCIT-sham biometric group. Outcome parameters include weekly ECBI and Pediatric Sleep Questionnaire (PSQ) as well as Child Behavior Checklist (CBCL) obtained weeks 1, 6, and 12 of the study. Two smartphone applications (Garmin connect and mEMA) and a wearable Garmin smartwatch are used collect the data to monitor step count, sleep, heart rate, and activity intensity. In the AI-PCIT group, the mEMA application will allow for the ecological momentary assessment (EMA) and will send behavioral alerts to the parent. DISCUSSION: Real-time predictive technologies to engage patients rely on daily commitment on behalf of the participant and recurrent frequent smartphone notifications. Ecological momentary assessment (EMA) provides a way to digitally phenotype in-the-moment behavior and functioning of the parent-child dyad. One of the study's goals is to determine if AI-PCIT outcomes are superior in comparison with standard PCIT. Overall, we believe that the PISTACHIo study will also be able to determine tolerability of smartwatches in children aged 3-7 with EBP and could participate in a fundamental shift from the traditional way of assessing and treating EBP to a more individualized treatment plan based on real-time information about the child's behavior. TRIAL REGISTRATION: The ongoing clinical trial study protocol conforms to the international Consolidated Standards of Reporting Trials (CONSORT) guidelines and is registered in clinicaltrials.gov (ID: NCT05077722), an international clinical trial registry.
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BACKGROUND: The cortical silent period (CSP) and long-interval intracortical inhibition (LICI) are putative markers of γ-aminobutyric acid receptor type B (GABAB)-mediated inhibitory neurotransmission. We aimed to assess the association between LICI and CSP in youths. METHODS: We analyzed data from three previous studies of youth who underwent CSP and LICI measurements with transcranial magnetic stimulation and electromyography. We assessed CSP and LICI association using Spearman rank correlation tests and multiple linear regression analyses adjusted for demographic and clinical covariates. RESULTS: The sample included 16 healthy participants and 45 participants with depression. The general mean (SD) age was 15.5 (1.7), 14.3 (1.7) for healthy participants, and 15.9 (1.6) years for participants with depression. Measures were nonnormally distributed (Shapiro-Wilk, p < 0.001). CSP and LICI were not correlated at 100-millisecond (ρ = -0.2421, p = 0.06), 150-millisecond (ρ = -0.1612, p = 0.21), or 200-millisecond (ρ = -0.0507, p = 0.70) interstimulus intervals using Spearman rank correlation test. No correlations were found in the multiple regression analysis (p = 0.35). CONCLUSIONS: Although previous studies suggest that cortical silent period and long-interval intracortical inhibition measure GABAB receptor-mediated activity, these biomarkers were not associated in our sample of youths. Future studies should focus on the specific physiologic and pharmacodynamic properties assessed by CSP and LICI in younger populations.
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AIM: To appraise the current evidence on the efficacy and safety of lamotrigine (LAM) in the treatment of pediatric mood disorders (PMD) (i.e., Major Depressive disorder [MDD], bipolar disorder [BD]). METHODS: Major databases were searched for randomized controlled trials (RCTs), open-label trials, and observational studies reporting on pediatric (age < 18 years) patients treated with LAM for mood disorders. RESULTS: A total of 3061 abstracts were screened and seven articles were selected for inclusion. Seven studies (319 BD and 43 MDD patients), including one RCT (n = 173), three prospective (n = 105), and three retrospective (n = 84) studies, met the study criteria with a study duration range from 8 to 60.9 weeks. The mean age of this pooled data is 14.6 ± 2.0 years. LAM daily dosage varied from 12.5 to 391.3 mg/day among the studies. In an important finding, the RCT reported favorable outcomes with LAM (HR = 0.46; p = 0.02) in 13- to 17-year-old age group as compared with 10- to 12-year-old age group (HR = 0.93; p = 0.88). In addition, time to occurrence of a bipolar event trended toward favoring LAM over placebo. All the studies identified LAM as an effective and safe drug in PMDs especially, BDs. Overall, LAM was well tolerated with no major significant side effects and no cases of Stevens-Johnson syndrome. CONCLUSIONS: Most studies suggested that LAM was safe and effective in pediatric patients with mood disorders. However, the data regarding the therapeutic range for LAM are lacking. Based on the data, there is inconsistent evidence to make conclusive recommendations on therapeutic LAM dosage for mood improvement in the pediatric population. Further studies including larger sample sizes are required to address this relevant clinical question.
