Harrington 1998.
Study characteristics | ||
Methods |
Allocation: randomisation using a series of opaque sealed envelopes which contained either a blank sheet or one bearing the letter F (for family therapy). Follow‐up period: 6 months. N lost to follow up: 13/162 (8%) for repetition data. |
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Participants |
Inclusion criteria: i) 16 years of age or younger; ii) engaged in an episode of self‐poisoning; iii) living in a family. Exclusion criteria: i) engaged in self‐cutting or hanging; ii) in social service care; iii) current investigation of physical or sexual abuse; iv) diagnosed with a contraindicated psychiatric condition (e.g., psychosis); v) currently in inpatient treatment; vi) parent or child diagnosed with a learning disability; vii) parent or child seriously suicidal. Numbers: Of the 162 participants, 85 were allocated to the experimental arm and 77 to the control arm. Profile: 89.5 % (n = 145) were female, 64.5% (n = 104) were diagnosed with major depression, 10.5% (n = 17) were diagnosed with conduct disorder, 100% (n = 162) had a history of self‐poisoning. Source of participants: patients referred to mental health teams in one of four hospitals. Location: Manchester, UK. |
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Interventions |
Experimental: manualised home based family therapy intervention involving one assessment session and 4 home visits in addition to treatment as usual. Control: treatment as usual. Therapist: 2 psychiatric social workers with a master’s degree. Type of therapy offered: family therapy. Length of treatment: not stated. |
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Outcomes |
Included: i) repetition (data obtained from study authors); ii) suicide; iii) suicidal ideation; iv) compliance; v) hopelessness; vi) problem solving; vii) depression. Excluded: i) family functioning; ii) satisfaction with treatment; iii) cost‐effectiveness; iv) parent General Health Questionnaire. |
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Notes |
Source of funding: "This research was supported by the Department of Health, London" (p.517). Declaration of author interests: no details on author interests were provided. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "a series of opaque and sealed envelopes containing either a blank sheet or the letter F were prepared and randomly assorted by an assistant" (p.2). Comment: Although it is likely the random sequence was adequately generated, without further information on the method used, this cannot be ascertained. |
Allocation concealment (selection bias) | Low risk | Quote: "a series of opaque and sealed envelopes containing either a blank sheet or the letter F were prepared and randomly assorted by an assistant” (p.2). Comment: Use of opaque sealed envelope containing either a blank sheet or a sheet with the letter F printed on it would ensure that allocation was adequately concealed. |
Blinding (performance bias and detection bias) Of participants | High risk | Comment: The nature of this study means that participants could have known to which group they had been allocated. |
Blinding (performance bias and detection bias) Of personnel | High risk |
Quote: “[The envelopes] were opened by the social worker at the time of the assessment, who then assigned the case to the family intervention plus routine care or routine care alone” (p.2) Comment: Personnel were not blinded. |
Blinding (performance bias and detection bias) Of outcome assessors | Low risk | Quote: “Treatment assignment was entered on a register and concealed from the outcome assessors” (p.2) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: “Outcome assessments were conducted with 154 (96%) of 162 cases at two months and 149 (92%) of 162 cases at six months” (p.3). “All the analyses were conducted ‘intent to treat’” (p.3). |
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. |