Hazell 2009.
Study characteristics | ||
Methods |
Allocation: random allocation conducted by a distant site coordinator. Follow‐up period: 12 months N lost to follow up: 0/72 for repetition data. |
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Participants |
Inclusion criteria: i) aged between 12 and 16 years; ii) referred to a child and adolescent mental health service in Newcastle, Brisbane North, or Logan; iii) reported at least two episodes of self‐harm in the past year, one of which occurred within the past 3 months. Exclusion criteria: i) required intensive treatment owing to an imminent risk of SH; ii) diagnosed with acute psychosis; iii) diagnosed with an intellectual disability or other disorder that would indicate the patient was unlikely to benefit from group therapy sessions; iv) current level of SH risk precluded participation in group therapy sessions. Numbers: Of the 72 participants, 35 were allocated to the experimental arm and 37 to the control arm. Profile: 90.3% (n = 65) were female, 100% (n = 72) were multiple repeaters, 4.1% (n = 3) had alcohol problems, 0% (n = 0) had substance misuse problems, 56.9% (n = 41) were diagnosed with depression; 6.9% (n = 5) had a diagnosis of conduct/oppositional defiant disorder. Source of participants: patients referred to a child and adolescent mental health service who had reported at least two episodes of SH in the past year, one within the past 3 months. Setting: Newcastle, Brisbane North, and Logan, New South Wales and Queensland, Australia. |
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Interventions |
Experimental: group therapy involving CBT, social skills training, interpersonal psychotherapy, group psychotherapy in addition to treatment as usual. Control: treatment as usual involving individual counselling, family sessions, medication assessment and review, and other care co‐ordination. Therapists: clinicians in community‐based adolescent mental health services. Type of therapy offered: group psychotherapy. Length of treatment: 12 months. |
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Outcomes |
Included: i) repetition of SH according to self‐report; ii) suicide; iii) suicidal ideation; iv) depression. Excluded: None |
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Notes |
Source of funding: no specific sources of funding were reported for this study. Declaration of author interests: "Prof. Hazell has received research funding from Celltach and Eli Lilly; has served as a consultant to Eli Lilly, Janssen‐Cilag, Novartis, and Shire; and has participated in the speakers' bureaus of Eli Lilly, Janssen‐Cilag, and Pfizer. The other authors report no conflicts of interest" (p.669). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: Correspondence with study authors revealed that a computer generated random number table was used to generate the random sequence. Randomisation by location and by blocks of four were also used to ensure a similar number of adolescents were recruited from each study location. |
Allocation concealment (selection bias) | Low risk |
Quote: "The local site co‐ordinator emailed the distant site co‐ordinator, who assigned a trial number and randomly allocated that adolescent to group therapy or routine care" (p.664) Comment: Use of a remote site co‐ordinator is likely to have ensured allocation was adequately concealed. |
Blinding (performance bias and detection bias) Of participants | High risk | Quote: "The adolescent was informed of his or her allocation by a letter and by their routine care therapist" (p.664). |
Blinding (performance bias and detection bias) Of personnel | High risk | Quote: "The adolescent was informed of his or her allocation by a letter and by their routine care therapist" (p.664) Comment: Given that the therapist is informing participants as to their allocation, this would suggest personnel were also not blinded to allocation. |
Blinding (performance bias and detection bias) Of outcome assessors | Low risk | Quote: "Treatment allocation was concealed from the outcome assessors, who were asked at the end of the study to nominate which treatment had been given to the adolescents" (p.664) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk |
Quote: "Continuous outcome data were analyzed on an intent‐to‐treat basis" (p.664) Comment: Intention‐to‐treat analyses made using the last outcome carried forward method. |
Selective reporting (reporting bias) | Unclear risk | Comment: No reason to suspect that all outcomes were not measured, however, in the absence of the trial protocol, this cannot be ascertained. |
Other bias | Low risk | Comment: No apparent other sources of bias. |