Lock 2010.
| Methods | RCT | |
| Participants | Country: USA
Diagnostic tool: DSM‐IV criteria for AN excluding the amenorrhoea criterion
No. screened: telephone screening N = 331, invited for an assessment interview N = 175 (53%)
No. randomised: Total: 121; FBT: 61; AFT: 60
No. started trial: FBT: 57; AFT: 59
No. dropped out during intervention: Total: 12; FBT: 9; AFT: 3
No. dropped out during follow‐up: 6 months; FBT: 18; AFT: 14; 12 months: FBT:17; AFT: 11
No. analysed (observed case): FBT end of treatment: 50; FBT 6 months: 44; FBT 12 months: 45; AFT end of treatment: 49; 6 months: 47; 12 months: 49 Mean age in years (SD): Total: 14.4 (1.6) years; FBT: 14.1 (1.7); AFT: 14.7(1.5) Age range in years: Not stated, but needed to be between 12 and 18 years (inclusion criteria) Gender %: No detail Subtype purging %: 17.4% (n = 21) "Binge‐purge" subtype Subtype restricting %: No detail Age of onset: No detail Duration of illness: Total: 11.3 (8.6) months; FBT: 12.3 (8.5) months; AFT: 10.3 (8.7) months Baseline weight Mean IBW%: 82 Baseline BMI: 16.1 (1.1) Baseline eating disorder scale score EDE: Total: 1.77 (1.45); FBT: 1.5 (1.3): AFT: 2.1 (1.3) Baseline purging: No detail Comorbidity: Approximately ¼ of participants (24.5%, n = 29) met criteria for a current comorbid psychiatric disorder, as assessed by the Schedule for Affective Disorders and Schizophrenia for School‐Aged Children. FBT: 20% with psych comorbidity; AFT: 32% with psychiatric co‐morbidity Details on living arrangements: 79% were from intact families. All participants lived at home or with legal guardian. Family education/employment/income, parental education mean years (SD): FBT: 17.0 (3.1); AFT: 17.1 (2.6) Recruitment strategy: Participants were recruited by advertising to clinicians, organisations, and clinics treating eating disorders. After telephone screening (N = 331) to determine eligibility, 175 (53%) were invited for an assessment interview Exclusion criteria:
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| Interventions | Setting of care: Outpatients, but hospitalisation allowed if required on medical grounds
Training/qualification of care provider(s): PhD psychologists and 2 child psychiatrists
Treatment manual: "use of manualised treatments", no further information
Supervision of treatment: Weekly
Adherence to treatment: Unclear. Therapists treated 3 pilot cases satisfactorily with each treatment prior to treating randomised cases. No details about monitoring treatment adherence during trial
Intervention group 1
Description: Family‐based therapy Length: 60 mins, 24 sessions (24 hours), 12 months Intervention group 2 Description: Adolescent‐focused therapy (AFT) Participants learn to identify and define their emotions and later to tolerate affective states rather than numbing themselves with starvation. Originally described by Robin 1999 as ego‐oriented individual therapy Length: 32 x 45‐minute sessions (24 hours), 12 months |
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| Outcomes |
Eating psychopathology
EDE, version 12.0
Behavioural indices
Remission: those who achieved 95% IBW, adjusted for age, sex, and height, and total EDE score within 1 SD of normal
Relapse BMI, BMI % for age and sex and percentage EBW (% EBM), IBW Family Functioning McMaster FAD |
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| Notes | Funded by: Stanford University and National Institute of Mental Health (NIMH) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was performed separately for each site by a biostatistician in the Data and Co‐ordinating Center under independent management from either intervention site. The Efron biased coin design was used to balance treatment within sites. Participants were stratified within sites based on current use of psychiatric medication |
| Allocation concealment (selection bias) | Low risk | See above: Randomisation was performed separately for each site by a biostatistician in the Data and Co‐ordinating Center under independent management from either intervention site. This can be considered sufficient for a low risk of bias for 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 | Unclear risk | Quote: "independent assessors", no further detail |
| Incomplete outcome data (attrition bias) All outcomes | High risk | > 29.5% data missing for some outcome/follow‐up measures, paper states "Intent‐to‐treat mixed‐effects modelling used all available data", but analysis appears to have been observed case in some instances |
| Selective reporting (reporting bias) | Low risk | Results from all measures appear to have been reported |
| Other bias | Unclear risk | Researchers involved in the trial also developed the intervention. |