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. 2019 May 1;2019(5):CD004780. doi: 10.1002/14651858.CD004780.pub4

Lock 2015.

Methods RCT (unbalanced design)
Participants Country: Not reported (author affiliation listed as USA)
 Diagnostic tool: DSM‐IV TR criteria for AN,except for the amenorrhoea requirement
 No. screened: 70
 No. randomised: Total: 45; FBT: 10; FBT/IPC: 35
 No. started trial: No detail
 No. dropped out during intervention: Total: 9; FBT: 2; FBT/IPC: 7
 No. dropped out during follow‐up: No detail
 No. analysed (observed case): Unclear, no detail
Mean age in years (SD): FBT: 14.3 (1.5); FBT/IPC: 14.6 (1.4)
 Age range in years: No detail
 Gender % female: FBT: 90; FBT/IPC: 92.07
 Subtype purging %: No detail
 Subtype restricting %: No detail
 Age of onset: No detail
 Duration of illness, months: Total:12.6 (13.7)
 Baseline weight: No detail
 Baseline BMI : FBT: 16.1 (1.1); FBT/IPC: 16.2 (0.9)
 Baseline eating disorder scale score Global EDE: FBT: 1.8 (1.6); FBT/IPC: 1.9 (1.5)
 Baseline purging: No detail
 Comorbidity (depression, anxiety, obsessive compulsive, panic, phobia, adjustment disorders): FBT 30%; FBT/ICP: 52.4%
 Details on living arrangements, intact family: FBT: 80%; FBT/IPC: 85.3%
 Family education/employment/income: No detail
 Recruitment strategy: No detail
 
 Exclusion criteria:
  1. Psychotic illness/other mental illness requiring hospitalisation

  2. Were dependent on drugs or alcohol

  3. Physical illness that necessitated hospitalisation

  4. Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight

  5. Received previous FBT

  6. Not medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine

Interventions Setting of care: Outpatient
 Training/qualification of care provider(s): No detail
 Treatment manual: Yes for FBT, unclear for FBT/IPC
 Supervision of treatment: No detail
 Adherence to treatment: No detail
 
 Intervention group 1Description: Family‐based therapy (FBT)
Includes a family meal
Length: Sessions: Mean (SD) 12.9 (3.6); 6 months (target: 15 sessions over 6 months)
 
 Intervention group 2Description: Family‐based therapy + intensive family coaching (FBT + IPC)
 In the adaptive treatment arm, FBT/IPC+ provides 3 sessions of IPC added to standard FBT focused on meal time coaching for families whose child had not gained 2.3 kg (4.8 lbs) by session 4. The first of these sessions (new session 5) is a family session designed to present the failure in sufficient weight gain by this point as a crisis and strives to reinvigorate the family to make definitive behavioural changes to support weight restoration. Following this session (new session 6), a session with the parents only is held to identify what impediments the parents perceive might be interfering with successful re‐feeding. Finally, a second family meal (new session 7) is held which includes direct coaching by the therapist to help address the specific challenges identified during the meeting with the parents alone. Following these 3 sessions, the treatment resumes the regular course of standard FBT. Participants in this arm who did gain 2.3 kg by session 4 did not receive the IPC sessions.
Length: Sessions: Mean (SD) 13.9 (4.3); 6 months (target: 18 sessions over 6 months)
Outcomes Eating psychopathology
EDE Global Score
Behavioural indices
Recovery (% EBW > 95)
Weight
BMI
General Psychopathology and Obsessionality
CYBOCS
YBCEDS Total
BDI
(RSE
HRQ
Global pathology and interpersonal functioning
TSPE
Notes Funded by: NIMH to Dr. Lock (PI) R34‐MH09349303, Dr. Le Grange (PI) R34‐MH093768, and Dr. Agras, (co‐PI), R34‐MH09349303
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No detail
Allocation concealment (selection bias) Unclear risk No detail
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 No detail
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Outcome data reported for all randomised participants (unclear if ITT or observed case outcome data used)
Selective reporting (reporting bias) High risk Parents Versus Anorexia Nervosa Scale, PvAn, not reported for all groups at end of treatment, Schedule for Affective Disorders and Schizophrenia for School‐Aged Children (6 ‐ 18 years) ‐ Present and Lifetime Version (K‐SADS‐PL) not reported at end of treatment. Family income data discussed but not reported
Other bias Unclear risk Unbalanced randomised design N = 10 in FBT; N = 35 in FBT/IPC (but N = 23 in FBT/IPC had only FBT, e.g. FBT/IPC‐; N = 12 in FBT/IPC had FBT and IPC, e.g. FBT/IPC+)