Functionality among preschoolers with attention-deficit/hyperactivity disorder (ADHD) improves with 8 weeks of methylphenidate therapy, according to study results published in The Lancet Child & Adolescent Health.
Children (N=153) aged 3 to 5 years with moderate to severe ADHD were recruited from the University of São Paulo Medical School in Brazil between 2018 and 2019. The children and their parents were randomly assigned in a 1:1:1 ratio to receive methylphenidate plus sham parent training (n=51), placebo plus parent training (n=51), or placebo plus sham training (n=51) for 8 weeks.
Methylphenidate was administered in dosages of 0.3 mg/kg per day during week 1 and was titrated up to 1.0 mg/kg per day (or 1.25 mg/kg if not effective) from week 5. The parent training interventions comprised weekly 90-minute sessions with the child and parent. Two psychologists and the active intervention followed the Helping the Noncompliant Child protocol and the sham intervention focused on general child development.
The children were a mean age of 60.45 (SD, 7.60) months and 84% were boys. A total of 71% of the children had combined inattention and hyperactivity or compulsivity ADHD; Swanson, Nolan, and Pelham-IV (SNAP-IV) scale parent and teacher average (P/T) score was 36.40 (SD, 7.20); Clinical Global Impression–Severity scale (CGI-S) score was 4.71 (SD, 0.70); and Children’s Global Assessment Scale (CGAS) score was 48.93 (SD, 6.57). Among the parents, 8% did not complete middle school and they had an average Brazilian criteria socioeconomic status score of 28.76 (SD, 8.38).
Between baseline and week 8, SNAP-IV-P/T scores increased by 8.90, CGI-S scores increased by 0.92, and CGAS scores decreased by 8.59 among the methylphenidate plus sham training cohort; by 6.82, 0.64, and -6.44 among the placebo plus training cohort; and by 3.98, 0.29, and -3.76 among the placebo plus sham training cohort, respectively. Overall, there were significant time-by-group interactions for all 3 instruments (all P ≤.035).
In the pairwise comparison analyses, methylphenidate plus sham was superior to placebo plus sham for improving SNAP-IV-P/T (mean difference [MD], -3.93; P =.049), CGI-S (MD, -0.49; P =.0088), and CGAS (MD, 5.25; P =.0036) scores, and placebo plus training was superior over placebo plus sham for improving CGAS scores (MD, 3.69; P =.033).
Moderate adverse events were reported by more methylphenidate recipients than placebo recipients (P <.0001), and more methylphenidate recipients reported severe decreased appetite (P =.032). Overall, 67% of patients reported only mild events, 22% reported at least 1 moderate adverse event, and 1% reported at least 1 severe adverse event.
At the physical examination, the methylphenidate recipients tended to lose weight while the placebo recipients gained weight (P =.0012).
This study was limited by not including a methylphenidate plus parent training intervention arm.
Study authors conclude, “Methylphenidate was well tolerated and effective in reducing the frequency and severity of ADHD symptoms and improving global functioning. Behavioral parent training was not superior to placebo plus educational intervention in reducing the frequency and severity of ADHD symptoms but did improve global functioning.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Sugaya LS, Salum GA, Gurgel WdS, et al. Efficacy and safety of methylphenidate and behavioural parent training for children aged 3–5 years with attention-deficit hyperactivity disorder: a randomised, double-blind, placebo-controlled, and sham behavioural parent training-controlled trial. Lancet Child Adolesc Health. Published online October 25, 2022. doi:10.1016/S2352-4642(22)00279-6