Investigation of Multi-Family Therapy for Anorexia Nervosa

NCT06203418 | Active Not Recruiting

• 1 other identifier: 2020-0217
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed project is an intensive multi family therapy (MFT) intervention involving patients with anorexia nervosa and their families. MFT interventions are informed from the principles of the family based treatment (FBT)/family therapy for Anorexia Nervosa (FT-AN) models. This program will offer families in vivo/virtual support while connecting with other families to increase knowledge of eating disorders and develop skills related to successfully supporting their adolescent during difficult times, including meal support and affect regulation. Our objective is to explore the influence of the MFT intervention on the primary outcome measures in eating disorder treatment, including weight, expressed emotion and eating disorder symptomatology.

Conditions

Anorexia Nervosa

Keywords

Multi-Family Therapy

Outcome Measures

Primary Outcomes (12)

• Effect on Eating Disorder Symptomatology (multiple variables) - 1. weight

  weight in lbs over time

  1 year

• Effect on Eating Disorder Symptomatology (multiple variables) - 2. BMI

  BMI (kg/m\^2): weight and height will be converted into appropriate units for calculation

  1 year

• Effect on Eating Disorder Symptomatology (multiple variables) - 3. Heart rate

  Heart Rate (beats per minute)

  1 year

• Effect on Eating Disorder Symptomatology (multiple variables) - 4. eating disorder thoughts and behaviors

  This is measured by 3 assessments that share scales. These assessments are the Eating Disorder Examination, Eating Disorder Examination Questionnaire and the Parent Eating Disorder Examination Questionnaire. Each of these measures have a total of 5 scales. These include Restraint, Eating Concern, Shape Concern and Weight Concern as well as a Global (total) score. This measured on a scale from 0-6 with 0 suggestion no presence of symptom and 6 representing maximum score. (Restraint, Eating Concern, Shape Concern and Weight Concern) and an overall global score, with a higher score indicating more problematic eating difficulties. Scale: 0-6

  1 year

• Effect on Eating Disorder Symptomatology (multiple variables) - 5. co-morbid psychiatric disorders

  Co-morbid psychiatric disorders measured by Mini-International Neuropsychiatric Interview for Children and Adolescents (MiniKid) is a short standardized diagnostic interview and covers a rather broad range of diagnoses applicable to children and adolescents. This results in a 0 or 1 score. 0 of diagnosis is not given, 1 if diagnosis is given

  1 year

• Effect on Eating Disorder Symptomatology (multiple variables) - 6. co-morbid psychiatric disorders

  Revised Children's Anxiety and Depression Scale (RCADS) is a 47-item, youth self-report questionnaire with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). To score the RCADS manually, each item is assigned a numerical value from 0-3, where 0 = Never, 1 = Sometimes, 2 = Often, and 3 = Always. Higher number suggests higher severity.

  1 year

• Effect on Eating Disorder Symptomatology (multiple variables) - 7. co-morbid psychiatric disorders

  Hospital Anxiety and Depression Scale (HADS) Hospital Anxiety and Depression Scale (HADS) - Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. is a 47-item, youth self-report questionnaire with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). To score the RCADS manually, each item is assigned a numerical value from 0-3, where 0 = Never, 1 = Sometimes, 2 = Often, and 3 = Always. Higher number suggests higher severity.

  1 year

• Effect on Eating Disorder Symptomatology (multiple variables) 8. sleep quality

  Consensus Sleep Diary (CSD). 15 items to prospectively assess subjective estimates of daily sleep patterns, including time eyes closed, sleep-onset latency, number of awakenings, time of final awakening, and total time spent awake after sleep onset. Additional items include a Likert rating of sleep quality, medication use, and naps.Sleep diaries are universally the preferred method for collecting self-reported sleep data. There is no score on this measure Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance and Sleep-Related Impairment, 8-item short forms. The PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks are self-report eight item measures that assesses perceptions of sleep depth, restoration, and quality over the past seven days. Higher scores indicating greater sleep/wake disturbances.

  1 year

• Effect on Eating Disorder Symptomatology (multiple variables) - 9. expressed emotion

  Expressed Emotion measured by Difficulties in Emotional Regulation (DERS). The DERS is a self-report measure of subjective emotion ability, as defined by a prominent clinically derived model of emotion regulation. Higher scores suggest greater problems with emotion regulation.

  1 year

• Effect on Eating Disorder Symptomatology (multiple variables) - 10. expressed emotion

  Expressed Emotion measured by Brief Dyadic Scale of Expressed Emotion This is a 14 item self-report questionnaire. The items of this self- report measure are scored on a 10-point Likert scale. Higher scores indicate higher levels of criticism/expressed emotion.

  1 year

• Effect on Eating Disorder Symptomatology (multiple variables) - 11. expressed emotion

  Expressed Emotion measured by Family Questionnaire (FQ) The Family Questionnaire (FQ),is The Family Questionnaire (FQ) is a 20-item, self-administered questionnaire that measures expressed emotion status (criticism and emotional over involvement \[EOI\]) of family members toward patients with mental illness. Expressed Emotion measured by Family Questionnaire (FQ) The FQ has two sub-scales: critical comments, and EOI. Each item is rated on a 4-point scale (1 = never/very rarely; 4 = very often). The FQ is scored by adding together the ratings from the individual items, with higher scores indicating greater levels of expressed emotion.

  1 year

• Effect on Eating Disorder Symptomatology (multiple variables) - 12. Parenting styles

  Parenting Styles categorized by Diana Baumrind's 4 parenting styles including authoritative, authoritarian, permissive, and uninvolved parenting styles. This is assessed by the MFT intensive leaders at the beginning of the MFT intervention at Day 1 and then again at Day 4. This assessment results in parents being categorized into one of the 4 parenting styles.

  1 year

Secondary Outcomes (2)

• Implementation and feasibility of virtual adaptation of MFT 1. participant retention

  4 years

• Implementation and feasibility of virtual adaptation of MFT - 2. participant satisfaction

  4 years

Study Arms (1)

Intervention

EXPERIMENTAL

Multi-Family Therapy

Behavioral: Multi-Family Therapy

Interventions

Multi-Family Therapy BEHAVIORAL

Multi family therapy for anorexia nervosa (MFT-AN) draws on the same principles as FBT but is delivered in a more intensive format to help families to overcome a sense of isolation and stigmatization and to maximize their own resources. In the case of eating disorders, this program utilizes FBT principles (both approaches are guided by the family-based treatment philosophy, which stresses the impact of ED on family functioning and attempts to mobilize families as the primary agents of change in achieving recovery), and also utilizes learning from structural, systemic, strategic, narrative, and psychodrama-based family therapy practices,(Knatz et al., 2015). Generally between 5-7 families take part in MFT, sharing their experiences, learning by example, and providing support for one another. Study will utilize virtual adaptation of manualized treatment published by Simic et al 2021

Intervention

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English speaking
• living at home with at least one parent/guardian
• diagnosis of restricting eating disorder
• years of age
• Medically stable per medical clearance form

You may not qualify if:

• Active psychosis (parent or child)
• Current dependence on drug or alcohol (parent or child)
• Past history/current abuse (sexual/physical), neglect

Sponsors & Collaborators

• Blue Cross Blue Shield: collaborator
• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Arbit SE, Anderson K, Desai S, Bernstein K. Investigation of virtual multi-family therapy for adolescent anorexia nervosa: feasibility and acceptability. J Eat Disord. 2026 Mar 27. doi: 10.1186/s40337-026-01575-0. Online ahead of print.

  PMID: 41888889 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: January 12, 2024
• Study Start: May 21, 2020
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)