Madden 2015.
| Methods | RCT | |
| Participants | Country: Australia
Diagnostic tool: DSM‐IV diagnosis of AN Total: ; MS + FBT: ; WR + FBT: No. screened: 266 No. randomised: Total: 82; MS + FBT: 41; WR + FBT: 41 No. started trial: MS + FBT: 40; WR + FBT: 38 No. dropped out during intervention: Total: 9; MS + FBT: 4; WR + FBT:5 No. dropped out during follow‐up: Total: 5; MS + FBT: 0; WR + FBT:5 No. analysed (observed case): Variable by outcome measure and follow‐up time Mean age in years (SD): Total: 14.89 (1.46); MS + FBT: 14.89 (1.36); WR + FBT: 14.88 (1.56) Age range in years: No detail, but inclusion criteria 12 to 18 years Gender % female: Total: 95.1; MS + FBT: 95.1; WR + FBT:95.1 Subtype purging %: Total: 30.51; MS + FBT: 29.27; WR + FBT: 31.73 Subtype restricting %: Total: 69.50; MS + FBT: 70.73; WR + FBT: 68.32 Age of onset: No detail Duration of illness: Total: 7.62 (6.16) months; MS + FBT: 7.39 (5.42) months; WR + FBT: 7.85 (6.89) months Baseline weight: Total: 78.26 (6.35) %EBW; MS + FBT: 77.28 (6.67) % EBW; WR + FBT: 79.25 (5.95) % EBW Baseline BMI: No detail Baseline eating disorder scale score, EDE total: Total: 3.07 (1.12); MS + FBT: 2.95 (1.14); WR + FBT: 3.19 (1.11) Baseline purging: See purging subtype above Comorbidity: Psychological feature: MS + FBT Mean (SD), WR + FBT mean (SD), Total Mean (SD) Depression features: 13 (31.7), 13 (31.7), 26 (31.7) Self‐harm/suicidality: 14 (34.2), 15 (36.6), 29 (35.8) Anxiety features: (34.2), 18 (43.9), 32 (39.0) OCD: 6 (14.6), 9 (22.0), 15 (18.3) PTSD/trauma/grief: 8 (19.5), 6 (14.6), 14 (17.1) Developmental/intellectual concerns: 2 (4.9), 5 (12.2), 7 (8.5) RCADS: Depression: 58.12 (15.51), 56.80 (14.86), 57.46 (15.11) RCADS: Anxiety: 49.15 (12.47), 52.78 (14.28), 50.96 (13.45) ChOCI‐R: Frequency of obsessions: 16.56 (3.75), 18.02 (6.26), 17.29 (5.18) Details on living arrangements, single parent %: Total: 26.8; MS + FBT: 29.3; WR + FBT: 24.4 Family education/employment/income: No detail Recruitment strategy: 266 consecutive eating disorder admissions to 2 specialist paediatric medical units Exclusion criteria:
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| Interventions | Setting of care: Inpatient and outpatient
Training/qualification of care provider(s): 3 psychologists and a social worker trained in the FBT model
Treatment manual: FBT component of both treatments manualised
Supervision of treatment: Weekly individual and group supervision was provided by 2 experienced FBT therapists (AW and PR) with over 5 years of experience in FBT
Adherence to treatment: Where consent was provided (89% of families), treatment sessions were recorded on digital video and a random sample of 5% of these sessions were assessed for treatment fidelity by 1 of the authors of the FBT manual (DLG). No information provided about the level of adherence to treatment
Intervention group 1
Description: Medical stablisation + family‐based therapy (MS + FBT) MS: All participants were re‐fed using a standardised protocol starting with 24 – 72 hours of continuous nasogastric feeds (ceased with daytime medical stability) followed by a combination of nocturnal nasogastric feeds and supported meals aiming for a total caloric intake of between 2400 and 3000 kcal/day. The amount and duration of nasogastric feeding was determined by markers of medical instability for a minimum of 14 days. Total caloric intake was based on a rate of weight gain of 1 kg/week (Kohn 2011). Participants in the MS arm were subsequently discharged to outpatient FBT if they had no markers of medical instability for 72 hours after nasogastric feeds were ceased Length: Mean sessions (SD) 24.25 (8.51), 24.25 (hours), maximum of 12 months Intervention group 2 Description: Weight restoration + family‐based therapy (WR + FBT) WR: All participants were re‐fed using a standardised protocol starting with 24 – 72 hours of continuous nasogastric feeds (ceased with daytime medical stability) followed by a combination of nocturnal nasogastric feeds and supported meals aiming for a total caloric intake of between 2400 and 3000 kcal/day. The amount and duration of nasogastric feeding was determined by markers of medical instability for a minimum of 14 days. Total caloric intake was based on a rate of weight gain of 1 kg/week (Kohn 2011). Participants in the WR arm continued in hospital on supported meals without nasogastric feeding once they had no markers of medical instability for 72 hours, until they reached 90% EBW before discharge to outpatient FBT Length: Mean sessions (SD) 31.30 (12.60), 31.30 hours, maximum of 12 months |
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| Outcomes |
Eating psychopathology EDE Global score Behavioural indices Number of days of hospitalisation, following initial admission, used by the12‐month follow‐up Total number of hospital days used by the 12‐month follow‐up and the percentage of participants at full remission as defined by an EBW > 95% and an EDE global score within 1 SD of expected norms. Partial remission was also examined as defined by weight > 85% of EBW % EBW |
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| Notes | Funded by: National Health and Medical Research Council (NHMRC) of Australia (Grant ID 457235). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomised in clusters of 6 using a block size of 2. Each new cluster was randomised through a blind random binary list created by an external statistician |
| Allocation concealment (selection bias) | High risk | Although the use of clusters unblinded recruitment staff to the group status of participants, this design was chosen to prevent potential problems of dropout if participants from different groups were treated alongside one another in hospital and became dissatisfied with their allocation. Participants and families were blind to treatment assignment prior to randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Therapists and participants cannot be blinded in trials of family‐based therapy |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | A clinical psychologist blind to treatment assignment conducted all baseline interviews and collected questionnaires at assessment time points |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Some missing outcome data and appear to have used observed case in the analysis |
| Selective reporting (reporting bias) | High risk | A number of measures not reported at EOT, e.g. RCADS, ChOCI‐R, RSES |
| Other bias | Unclear risk |
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