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Social-skills and parental training plus standard treatment versus standard treatment for children with ADHD--the randomised SOSTRA trial.

ABSTRACT: OBJECTIVE:To investigate the effects of social-skills training and parental training programme for children with attention deficit hyperactivity disorder (ADHD). METHODS:We conducted a randomized two-armed, parallel group, assessor-blinded superiority trial consisting of social-skills training plus parental training and standard treatment versus standard treatment alone. A sample size calculation showed at least 52 children should be included for the trial with follow up three and six months after randomization. The primary outcome measure was ADHD symptoms and secondary outcomes were social skills and emotional competences. RESULTS 56: children (39 boys, 17 girls, mean age 10.4 years, SD 1.31) with ADHD were randomized, 28 to the experimental group and 27 to the control group. Mixed-model analyses with repeated measures showed that the time course (y ?=? a + bt + ct(2)) of ADHD symptoms (p?=?0.40), social skills (p?=?0.80), and emotional competences (p?=?0.14) were not significantly influenced by the intervention. CONCLUSIONS:Social skills training plus parental training did not show any significant benefit for children with attention deficit hyperactivity disorder when compared with standard treatment. More and larger randomized trials are needed. TRIAL REGISTRATION:ClinicalTrials.gov NCT00937469.

SUBMITTER: Storebo OJ

PROVIDER: S-EPMC3380035 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Social-skills and parental training plus standard treatment versus standard treatment for children with ADHD--the randomised SOSTRA trial.

Storebø Ole Jakob OJ Gluud Christian C Winkel Per P Simonsen Erik E

PloS one 20120620 6

<h4>Objective</h4>To investigate the effects of social-skills training and parental training programme for children with attention deficit hyperactivity disorder (ADHD).<h4>Methods</h4>We conducted a randomized two-armed, parallel group, assessor-blinded superiority trial consisting of social-skills training plus parental training and standard treatment versus standard treatment alone. A sample size calculation showed at least 52 children should be included for the trial with follow up three and ...[more]

PMID: 22745657

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Project description:PurposeChemotherapy-induced peripheral neuropathy (CIPN) is a dose limiting toxicity posing a major clinical challenge for managing patients receiving specific chemotherapy regimens (e.g., Taxanes). There is a growing body of literature suggesting acupuncture can improve CIPN symptoms. The purpose of the ACUFOCIN trial was to collect preliminary data on the safety, feasibility, acceptability and initial effectiveness of acupuncture as a treatment for CIPN, comparing use of acupuncture plus standard care (Acupuncture) against standard care alone (Control).MethodAt a tertiary cancer centre, a pragmatic, randomised, parallel group design study was used to investigate the effectiveness of a 10-week course of acupuncture. Participants experiencing CIPN of ≥ Grade II, recording a 'Most Troublesome' CIPN symptom score of ≥3 using the "Measure Yourself Medical Outcome Profile" (MYMOP 2), were randomised to 'Acupuncture' or 'Control' arms. Clinicians were blinded to allocated groups, however as it was not possible to blind participants, it cannot be guaranteed they did not disclose study allocation within their clinic assessments. The primary outcome measure was the number of patients reporting a ≥ 2-point improvement (success) in their MYMOP2 score at week 10. 100 participants (120 to allow for attrition) were required for a hypothesised improvement in success proportions from 30% to 55% using a primary analysis model with logistic regression adjusted for stratification factors and baseline MYMOP2 scores. Feasibility and acceptability of study design was addressed through percentage return of primary outcome, retention rate and a nested qualitative study.ResultsPrimary MYMOP2 outcome data at week 10 was available for 108/120 randomised participants; this is greater than the 100 participants required to adequately power the study. There were 36/53 (68%) successes in 'Acupuncture' compared to 18/55 (33%) in 'Control'. Beneficial effects were seen in the secondary outcome data, including clinicians' grading of neuropathy, EORTC, QLQ-CIPN20, QLQ-C30 summary scores and patient reported pain scores. There were no serious adverse events reported within the study and only 16 acupuncture associated events, none of which required intervention.ConclusionA 10-week course of acupuncture resulted in measurable improvement in participants symptoms of CIPN. The results warrant further investigation.

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Social-skills and parental training plus standard treatment versus standard treatment for children with ADHD--the randomised SOSTRA trial.

Publications

Social-skills and parental training plus standard treatment versus standard treatment for children with ADHD--the randomised SOSTRA trial.

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