Efficacy of a stepped-care approach for school-age children with mild to moderate ADHD (ESCAschool-moderate): an adaptive intervention study including a randomized controlled trial.

内容摘要

This German multicenter study aimed to analyze the efficacy of telephone-assisted self-help (TASH) and changes during subsequent adaptive treatment in children with mild-to-moderate ADHD. Participants were children (6;0-11;11&#xa0;years) with mild-to-moderate ADHD. Study Step 1 comprised a randomized waitlist-controlled trial on the efficacy of three-month, parent-directed TASH. Depending on their response to TASH, in Step 2, children were assigned to booster TASH (full response), behavior therapy (partial response), or pharmacotherapy plus behavior therapy or counseling (non-response) for six months. The primary outcome was the change in blinded-clinician-rated ADHD symptoms; for subsequent changes (Step 2), we considered semi-blinded ratings. The primary analyses were by intention-to-treat. Of the 163 included children (77.9% boys), 80 were randomized to TASH and 83 to the waitlist control group. Following TASH, 12 children (8.8%) were classified as full responders, 40 (29.2%) as partial responders, and 85 (62.0%) as non-responders. An analysis of covariance did not yield an effect of TASH on the primary outcome (mean between-group difference&#x2009;=&#x2009;0.00&#x2009;&#xb1;&#x2009;0.07, 95% CI[-&#x2009;0.14, 0.13]; p&#x2009;=&#x2009;0.95; d&#x2009;=&#x2009;-0.01, 95% CI[-&#x2009;0.37, 0.34]). During Step 2, full responders demonstrated a stable symptom level (piecewise mixed-effects model for repeated measures; d&#x2009;=&#x2009;-&#x2009;0.07, 95% CI[-&#x2009;0.61, 0.47], p&#x2009;=&#x2009;0.80), partial responders a small increase in ADHD symptoms (d&#x2009;=&#x2009;0.29, 95% CI[0.00, 0.59], p&#x2009;=&#x2009;0.05), and non-responders a large decrease (d&#x2009;=&#x2009;-&#x2009;1.00, 95% CI[-&#x2009;1.27, -&#x2009;0.73], p&#x2009;<&#x2009;0.001). TASH is not effective in reducing blinded-clinician-rated ADHD symptoms in children with mild-to-moderate ADHD. Based on the changes within the response groups during Step 2, hypotheses are generated for adaptive treatment after TASH. Trial registration German Clinical Trials Register (DRKS): DRKS0000897; URL: https://drks.de/search/de/trial/DRKS00008973/details ; registered on December 18th 2015.