Le Grange 2016.

Methods	RCT
Participants	Country: Australia Diagnostic tool: DSM‐IV criteria for AN (excluding amenorrhoea). Given the anticipated publication of the DSM‐5 during the study, with its proposed deletion of the weight cut‐off for AN, inclusion criteria for weight was ≤90% median BMI for adolescents ≤75th percentile for height, and <95% median BMI for adolescents ≥75th percentile for height No. screened: 269 clinic assessment, 196 screened by interview No. randomised: Total: 107; FBT: 55; PFT: 52 No. started trial: 107 No. dropped out during intervention: Total: 17; FBT: 9; PFT: 7 + excluded from analysis: 1 No. dropped out during follow‐up: Total: 19; FBT 9 (with another 15 only partial assessments); PFT: 10 (with another 10 only partial assessments) No. analysed (observed case): Total: 106; FBT: 55; PFT: 51, ITT Mean age in years (SD): Total: 15.5 (1.5); FBT: 15.4 (1.3); PFT 15.7 (1.6) Age range in years: Total: 15.5 (1.5); FBT: 15.4 (1.3); PFT: 15.7 (1.6) Gender % female: Total: 87.7; FBT: 89.1; PFT: 86.3 Subtype purging %: No detail Subtype restricting %: No detail Age of onset: No detail Duration of illness: Mean months (SD) Total: 10.5 (8.8); FBT: 11.0 (9.4); PFT: 10.0 (8.1) Baseline weight: Total: No detail Baseline BMI Mean (SD): Total: 16.5 (1.3); FBT: 16.3 (1.2); PFT: 16.7 (1.4) Baseline eating disorder scale score: EDE Globabl Total: 2.15 (1.68); FBT: 2.20 (1.81); PFT: 2.09 (1.54) Baseline purging: Total: No detail Comorbidity Mood Disorder %: Total: ; FBT: 16.4; PFT: 29.4 Comorbidity Anxiety Disorder %: Total: 22.6; FBT: 21.8; PFT: 23.5 Comorbidity OCD% : Total: 5.7; FBT : 3.6; PFT: 7.8 Comorbidity Behavioural Disorder %: Total: 1.9; FBT: 3.6; PFT: 0.0 Comorbidity suicide or self‐harm risk %: Total: 10.4; FBT: 12.7; PFT: 7.8 Details on living arrangements ‐ "intact family" %: Total: 63.2; FBT: 61.8; PFT: 64.7 Family education/employment/income, University degree mother %: Total: 37.8; FBT: 43.1; PFT: 31.9 Family education/employment/income, University degree father %: Total: 38.2; FBT: 40.0; PFT: 36.1 Recruitment strategy: All patients who presented to the specialist clinic during the recruitment period (July 2010 to July 2014) were assessed for eligibility. Exclusion criteria: Medical instability as defined by the Amerian Academy of Pediatrics; Current psychotic disorder; Drug or alcohol dependence; Acute suicidality; Physical condition influencing eating or weight (e.g. pregnancy, cancer); Previous FBT for AN; Psychotropic medication < weeks. Must also be: living with at least 1 parent available to undertake treatment; and English proficiency by adolescents and parents at the sixth‐grade level
Interventions	Setting of care: Outpatient Training/qualification of care provider(s): "Therapist", no further details Treatment manual: Yes Supervision of treatment: Weekly supervision in both treatments Adherence to treatment: All treatment sessions for which consent has been provided are audio recorded Randomly‐selected recordings are reviewed by author DLG throughout the trial. No further detail Intervention group 1 Description: Family‐based therapy (FBT) Includes the entire family in treatment sessions, and a family meal Length: 18 sessions over 6 months. 10 minutes for participant weigh‐in with therapist + 50‐minute therapy session for family Intervention group 2 Description: Parent‐focused treatment (PFT) An adaptation of FBT, but parents are seen separately from client (other than first and last sessions) and there is no family meal Length: 18 sessions over 6 months. 15‐minute sessions with nurse for client, 50‐minute sessions with therapist for parents
Outcomes	Eating psychopathology EDE global, restraint, eating concerns, weight concerns, shape concerns Behavioural indices Recovery ‐ defined as: 95% mBMI and a global EDE score within 1 SD of community norms % median BMI Days drive exercise General Psychopathology and Obsessionality Child Depression Inventory Global pathology and interpersonal functioning Rosenberg self‐esteem scale
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	An off‐site biostatistician (RC) generated a randomisation schedule that was stratified by eating disorder severity (low versus high)
Allocation concealment (selection bias)	Low risk	The randomisation schedule is only accessible by designated staff members at the Royal Children’s Hospital who are independent of the Eating Disorders Programme team including the research team
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	Independent and trained assessors, who were not involved in treatment delivery, administered all assessments. No details provided about whether or not they were blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	"Missing data for continuous outcome measures at EOT and follow‐up were imputed using multiple imputation based on fully conditional Markov chain Monte Carlo modelling. The final analyses were based on the pooled results of 5 separate imputations. Treatment groups were then compared separately at EOT and at 6‐ and 12‐ month follow‐up using a general linear model for symmetric continuous outcomes, or a generalized linear model for non symmetric data. Covariates for all models included baseline observation, sex, age at baseline, and illness severity. Sensitivity analyses were conducted using maximum likelihood imputation and last observation carried forward, with results compared across the 3 methods" pg 687.
Selective reporting (reporting bias)	High risk	The following measures stated to have been administered, but not reported on, individually, only as results in moderator analyses: Children’s Yale–Brown Obsessive Compulsive Scale (CY‐BOCS),29 Yale–Brown–Cornell Eating Disorder Scale (YBC‐EDS), Mini International Neuropsychiatric Interview for Children and Adolescents (MINI‐Kid),31 Symptom Checklist‐90–Revised (SCL‐90‐R),32 Five Minute Speech Sample (FMSS), Therapy Suitability and Patient Expectancy (TSPE), Helping Relationship Questionnaire (HRQ), Parents Versus Anorexia (PVA),36 Positive and Negative Affect Scale–Expanded (PANAS‐X), Borderline Personality Questionnaire (BPQ), and the Family Environment Scale (FES)
Other bias	Unclear risk	Trial conducted by the developers FBT therapy treatment Funded by: Baker Foundation