Adolescent anorexia nervosa or atypical anorexia nervosa with rapid weight loss Mental and Behavioural Disorders Anorexia nervosa
Conditions
Interventions
Randomization:
Block randomization will be performed by the King’s Clinical Trials Unit who is not involved in data collection or analysis on this study. This will ensure blinding of the CI when colle
Eisler, et al., 2016). FT-AN is the NICE (2017) recommended treatment for adolescent eating disorders and has good outcomes. FT-AN is typically offered for 6 months. Young people and their families ar
Simimc, et al., in press) within the first 8 weeks of treatment. MFT is also NICE (2017) recommended and entails up to eight whole families working together with a clinical team over the course of a w
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/02/2021: Patient criteria: 1. Patient aged 10-17 years (inclusive) living with their parent/s or carer/s for at least the past 3 months 2. Diagnosis of anorexia nervosa in the child at clinical assessment using DSM-V criteria (APA, 2013) or atypical anorexia nervosa paired with rapid weight loss (< 15% mBMI over 3 months) 3. Assessed as medically and psychiatrically fit for outpatient treatment 4. Adequate level of English, i.e. sufficient to understand study information sheets and consent forms Parent/carer criteria: 1. Parent/carer of a child meeting inclusion criteria as above 2. Parent/carer will be involved in attending family therapy and multi-family therapy treatment sessions 3. Adequate level of English, i.e. sufficient to understand study information sheets and consent forms _____ Previous inclusion criteria: Patient criteria: 1. Patient age 10 – 18 years (inclusive) living with their parent/s or carer/s for at least the past 3 months 2. Diagnosis of anorexia nervosa in the child at clinical assessment using DSM-V criteria (APA, 2013) or atypical anorexia nervosa paired with rapid weight loss (< 15% mBMI over 3 months) 3. Assessed as medically and psychiatrically fit for outpatient treatment 4. Adequate level of English, i.e. sufficient to understand study information sheets and consent forms Parent/carer criteria: 1. Parent/carer of a child meeting inclusion criteria as above 2. Parent/carer will be involved in attending family therapy and multi-family therapy treatment sessions 3. Adequate level of English, i.e. sufficient to understand study information sheets and consent forms
Exclusion criteria
Exclusion criteria: Patient criteria: 1. Active psychotic disorder 2. Current physical and/or sexual abuse occurring in the household between any members of the family
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and acceptability measured in five domains: 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study during the study period (18 months) reported as a percentage 2. Feasibility of measurement tools recorded as: 2.1. The mean time taken to complete questionnaires in minutes 2.2. Amount of missing data per questionnaires reported as a percentage per measure 2.3. The number of participants who complete the questionnaire at 2 months, end of treatment (6 months), 6-month follow up and 12-month follow up, reported as a percentage of the total sample 3. Prospective acceptability recorded as: 3.1. Free text responses for why individuals did not take part or discontinued the trial 3.2. Mean responses to the Expectation of Improvement and Suitability of Treatment (EIST) 4. Acceptability of intervention for participants recorded as: 4.1. The total number of sessions attended recorded at the end of treatment (6 months) 4.2. The total number of sessions cancelled with reason recorded at the end of treatment (6 months) 4.3. The total number of sessions participants did not attend without provided notice recorded at the end of treatment (6 months) 5. Participant satisfaction measured using interview responses during qualitative interviews at the end of treatment (6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/02/2021: Measured at assessment, 2 months, end of treatment (6 months), follow up 1 (12 months), follow up 2 (18 months): 1. Weight: percentage median body mass index (%mBMI) 2. Psychiatric symptoms measured using EDE-A; RCADS 3. General functioning measured using WSAS-Y 4. Emotion regulation measured using DERS 5. Reflective functioning/mentalising measured using RFQ 5. Therapeutic alliance measured using SOFTA 6. Parental difficulties measured using HADS 7. Family functioning (criticism, warmth and emotional overinvolvement) measured using BDSEE, FQ, FMSS _____ Previous secondary outcome measures: Measured at assessment, 2 months, end of treatment (6 months), follow up 1 (12 months), follow up 2 (18 months): 1. Weight: percentage median body mass index (%mBMI) 2. Psychiatric symptoms measured using EDE-A; RCADS 3. General functioning measured using WSAS-Y 4. Emotion regulation measured using DERS 5. Reflective functioning/mentalising measured using RFQ 5. Therapeutic alliance measured using SOFTA; MFT-GQ 6. Parental difficulties measured using HADS 7. Family functioning (criticism, warmth and emotional overinvolvement) measured using BDSEE, FQ, FMSS | — |
Countries
England, United Kingdom
Contacts
Public ContactJulian Baudinet
Outcome results
None listed