Qian 2017.
Methods | Design: RCT, parallel group | |
Participants |
Country: China Setting: clinical Sample size calculation: not reported Sample size: 86 children Sex: 54 = boys, 14 = girls (group one: 32 (84.2%) = boys, 6 (15.8%) = girls; group two: 22 (73.3%) = boys, 8 (26.7%) = girls) Age: 6‐12 years (group one: mean = 8.3 years (SD = 1.3); group two: mean = 7.8 years (SD = 1.2)) Ethnicity: not reported Socioeconomic status: not reported IQ: group one: mean = 105.7 (SD = 13.9); group two: mean = 101.8 (SD = 10.4) ADHD diagnosis: group one: inattentive = 17 (44.7%), hyperactivity‐impulsivity = 0 (0%), combined = 21 (55.33%); group two: inattentive = 16 (53.3%), hyperactivity‐impulsivity = 1 (3.3%), combined = 13 (43.3%) ADHD medication: group one: 10 participants had maintained steady dosage of medications for more than a half year and remained unchanged during the entire study. New medications could not be initiated during the study. Comorbidity: group one: ODD = 7 (18.4%), learning disorder = 8 (21.1%), special phobia = 5 (13.2%); group two: ODD = 7 (23.3%), learning disorder = 4 (13.3%), special phobia = 2 (6.7%) Medications for comorbid disorders: not reported Inclusion criteria:
Exclusion criteria:
Baseline characteristics: no significant difference found in reported baseline characteristics |
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Interventions | 86 participants allocated to one of two groups
*Analysis, including baseline characteristics, was based on the following sample sizes: intervention = 38 participants, waiting‐list control = 30 participants Attendance: 86.4% (38/44) of children in intervention group complied with the training, completing 10 or more sessions in the 12‐session period. All missed group sessions were administered to the trainee individually. The percentage of the number of sessions administered individually was not specified. |
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Outcomes |
Primary outcomes
Secondary outcomes
Outcome assessment: post‐intervention assessment |
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Notes |
Study ID:NCT02327585 Sponsorship source: the study was supported by grants from the Beijing Municipal Science and Technology Commission (No. Z151100004015103), the Major State Basic Research Development Program of China (973 Program, No. 2014CB846100), National Key Research Plan of Ministry of Science and Technology of China (No. 2016YFC1306103), and the Capital Health Development Research Fund (No.2011‑4024‑04). Year conducted: 2017 Duration of the study: 12 weeks Comments: the study was conducted in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of Peking University Sixth Hospital. Lead author's name: Ying Qian Institution: Child Psychiatric Research Center, Peking University Sixth Hospital (Institute of Mental Health), National Clinical Research Center for Mental Disorders, Key Laboratory of Mental Health, Ministry of Health (Peing University) Email: yangli_pkuimh@bjmu.edu.cn, corresponding author Dr Li Yang Address: Beijing 100191, China |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: randomised block design with participants randomised to a block that comprised a permutation of four participants, two for each group separately. The design was used to balance the individuals between the intervention and waiting‐list groups. |
Allocation concealment (selection bias) | Low risk | Comment: randomisation grouping concealed in envelopes and recruited participant notified of his or her group sequentially |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: blinding not possible |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: primarily used parent rating scales and parents were not blinded to group status. Unclear, however, if assessors of executive functioning performance tests were blinded to group status |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 6/44 children in intervention group and 12/42 children in control (waiting‐list) group dropped out. No reasons given for dropout. Baseline data for the 18 children who dropped out not provided and no analysis of attrition |
Selective reporting (reporting bias) | High risk | Comment: The study registration specified the following secondary outcomes, which were not mentioned or reported in the paper: Conners; and Cambridge Neuropsychological Test Automatic Battery. The following measures were not mentioned in the study registration but were reported in the paper: BRIEF; WEISS Functional Impairment Scale‐Parents. |
Vested interest bias | Unclear risk | Comment: funding source not reported |
Other sources of bias? | Low risk | Comment: no other sources of bias identified |