Godart 2012.
| Methods | RCT | |
| Participants | Country: France
Diagnostic tool: DSM‐ IV
No. screened: 116
No. randomised: Total: 60; TAU + FT: 30; TAU: 30
No. started trial: Total: 58; TAU + FT: 29; TAU: 29
No. dropped out during intervention: Total: Total: 5; TAU + FT: 3; TAU: 2
No. dropped out during follow‐up: Total: 1; TAU + FT: 0; TAU: 1
No. analysed (observed case): Total: 59; TAU + FT: 29; TAU: 30 Mean age in years (SD): Total; 16.6 (1.6); TAU + FT: 16.4 (1.7); TAU: 16.6 (1.7) Age range in years: Total: 16.6 (1.6) years; TAU + FT: 17.3 (1.3); TAU: 16.9 (3.1) Gender %: Female 100% Subtype purging %: Total: 13.3% (8/60); TAU + FT: 16.7% (5/3); TAU: 10% (3/30) Subtype restricting %: No detail Age of onset: Total 14.8 (1.6); TAU + FT: 14.7 (1.7); TAU 15.0 (1.5) Duration of illness: Total: 16.6 (6.8) months; TAU + FT: 17.1 (8.3) months; TAU: 16.1 (5.2) months Baseline weight: Total: 83.6 (5.2) ABW% (at inclusion), 77.8 (8.9) EBW%, 42.9 (7.3) kgs; TAU + FT:83.9 (5.6) ABW%, 75.7 (7.2) EBW%, 43.7 (5.9) kgs; TAU: 83.3 (5.0) ABW%, 80.1 (10.3) EBW%, 42.0 (8.8) kgs Baseline BMI: Total: 16.9 (1.1); TAU + FT: 17.0 (1.2); TAU: 16.9 (1.0) Baseline eating disorder scale score: Total: 60.7 (35.1) EDI; TAU + FT: 61.3 (36.2) EDI; TAU: 60.2 (34.6) EDI Baseline purging: Total: 13.3% (8/60); TAU + FT: 16.7% (5/3); TAU: 10% (3/30) Comorbidity: "The two groups were comparable in terms of comorbid mood and anxiety disorders (i.e., major depressive disorder, social phobia, panic disorder, agoraphobia, obsessive compulsive disorder, post traumatic stress disorder; details available on request from the authors)." Pg 4 Details on living arrangements: Total: 9 (15%) not intact family status Family education/employment/income: No detail Recruitment strategy: AN hospitalised inpatients Exclusion criteria:
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| Interventions | Setting of care: Inpatient and outpatient
Training/qualification of care provider(s): The psychiatrist and psychologist involved in the study had > 4 years of experience in the outpatient care of AN adolescents
Treatment manual: Unclear for TAU, states manual not used for FT component
Supervision of treatment: No detail
Adherence to treatment: No detail
Intervention group 1
Description: Treatment as usual + family therapy Family therapy sessions targeting intra‐familial dynamics, but not eating disorder symptoms Length: 18 months, length and number of sessions unclear (Mean FT sessions attended 11.8, SD 5.7) Intervention group 2 Description: Treatment as usual Consisted in ambulatory care initiated before hospital discharge and was tailored according to the mental and physical state of the participant. It included individual consultations, regular interviews involving the parents, and, if required, individual psychotherapy with another therapist. At each appointment, the psychiatrist conducted clinical investigation of the participant’s mental state, eating habits, medical condition, and psychosocial environment. In addition, the psychiatrist provided support, co‐ordinated services (e.g. general practitioner, psychotherapist, dietician or nutritionist, social worker, and school), prescribed medication as necessary, and offered parental support and guidance regarding conflicts they had with their daughter. Parents were advised to be supportive but to leave decisions about food to the adolescent and to discuss the difficulties they observed not directly with their daughter during or after the meal, but at the time of the consultations with the psychiatrist and their daughter. In addition, nutritional/dietetic advice was provided to the participants who were not gaining weight or not gaining sufficient weight Length: 18 months, length and number of sessions unclear (Mean TAU sessions attended 27.2, SD 12.7) |
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| Outcomes |
Eating psychopathology MRS Outcome measures EDI Behavioural indices BMI Amenorrhea Rehospitalisation (psychiatric or for AN) Global pathology and interpersonal functioning GOAS SAS: Social Adjustment Scale |
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| Notes | Funded by: The study was funded by the Projet Hospitalier de Recherche Clinique (CRC‐ PHRC, 1997, AOM97133 AP‐HP French Ministry of Health); and promoted by Assistance Publique des Hôpitaux de Paris (AP‐HP). The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Allocation to 1 of the 2 parallel treatment groups (30 in each) was performed using the SPSS randomisation program (FC). The 2 groups were randomised by blocks of 30 |
| Allocation concealment (selection bias) | Low risk | The result was issued to participants in a sealed envelope at inclusion by the psychiatrist in charge of signing the consent form |
| 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 | Outcome assessor blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Some missing data, up to 18% of total sample (e.g. at 6‐month follow‐up), ITT analysis and LOCF analysis undertaken. |
| Selective reporting (reporting bias) | High risk | MINI reportedly administered at intake and end of treatment, but not reported at end of treatment. Data at 6 and 12 months not reported |
| Other bias | Unclear risk |
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