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:
|
|
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 1
Description: 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 2 Description: 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+) |