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NCT04421989

Parent Emotion Coaching for Anorexia Nervosa

Completed NA Results posted Last updated 26 February 2025
What this trial tests

NA trial testing Emotion Coaching in Anorexia Nervosa in 41 participants. Completed in 23 March 2023.

Timeline
24 June 2020
Primary endpoint
30 December 2022
23 March 2023

Quick facts

Lead sponsorChildren's Hospital Medical Center, Cincinnati
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment41
Start date24 June 2020
Primary completion30 December 2022
Estimated completion23 March 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 12 to 17, any sex, with Anorexia Nervosa or Atypical Anorexia Nervosa. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Criticism Primary · baseline, 1-month (halfway through the 10-session emotion coaching intervention), post-treatment, and 3-month follow- up

Parent Criticism was assessed by the Five Minute Speech Sample. This is a recorded five-minute unstructured response that the parent gives when prompted to talk about their feelings about their child. Eligible families will be categorized as high expressed emotion using a modified version of the Family Affective Attitudes Rating Scale (FAARS), which was developed to code the Five Minute Speech Sample in families with adolescents. Scores on Criticism range from 1-9 with higher scores reflective of greater parent criticism towards their adolescent (worse outcome).

1-Month
GroupValue95% CI
Emotion Coaching5.5± 2.8
Support Group3.7± 2.1
Post-Treatment
GroupValue95% CI
Emotion Coaching3.7± 2.0
Support Group4.3± 2.1
3 Month Follow-Up
GroupValue95% CI
Emotion Coaching2.6± 1.6
Support Group3.1± 2.0
Percent Expected Body Weight (%EBW) Primary · baseline, 1-month, post-treatment, and 3-month follow up

Percent Expected Body Weight is the current weight divided by the adolescent's Expected Body Weight based on their premorbid body mass index percentile for age-and-sex (Body Mass Index Percentile; Centers for Disease Control and Prevention, 2000). Expected Body Weights were calculated by research team members to ensure a standardized calculation methodology. One research team member extracted the highest and lowest premorbid Body Mass Index Percentile from each participant's medical chart and calculated the mean premorbid Body Mass Index Percentile, and Percent Expected Body Weight (i.e., curr

1-Month
GroupValue95% CI
Emotion Coaching95.1± 7.1
Support Group90.8± 7.8
Post-Treatment
GroupValue95% CI
Emotion Coaching96.6± 6.3
Support Group92.5± 8.3
3 Month Follow-up
GroupValue95% CI
Emotion Coaching98.0± 5.6
Support Group92.6± 10.4
Parental Warmth Secondary · baseline, 1-month, post-treatment, and 3 month follow-up

Parental Warmth was assessed by the Five Minute Speech Sample. This is a recorded five-minute unstructured response that the parent gives when prompted to talk about their feelings about their child. Eligible families will be categorized as high expressed emotion using a modified version of the Family Affective Attitudes Rating Scale (FAARS), which was developed to code the Five Minute Speech Sample in families with adolescents. Scores on Warmth range from 1-9 with higher scores reflective of greater parent warmth towards their adolescent (better outcome).

1-Month
GroupValue95% CI
Emotion Coaching7.0± 1.3
Support Group6.3± 1.8
Post-Treatment
GroupValue95% CI
Emotion Coaching7.8± 0.6
Support Group5.5± 1.9
3 Month Follow-Up
GroupValue95% CI
Emotion Coaching7.4± 1.7
Support Group7.5± 1.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Each adolescent participant was in the study for a duration of 6 months (from consent until follow up assessment).. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Emotion Coaching
Serious: 0/22 (0%)
Deaths: 0/22
Support Group
Serious: 0/19 (0%)
Deaths: 0/19
Other adverse events (2 terms — click to expand)

ReactionSystemEmotion CoachingSupport Group
Suicidal IdeationPsychiatric disorders
Acute Food RefusalPsychiatric disorders

Data from ClinicalTrials.gov NCT04421989 adverse events section.

Sponsor's own description

Family based treatment (FBT) is the evidence based treatment for pediatric anorexia nervosa (AN), but 50% of adolescents do not respond and the consequences for non-response are dire (e.g., 11.5% mortality rate). Expressed emotion and parental warmth are significant mechanisms of treatment outcome in adolescents with AN, which are not explicitly targeted by FBT. The current proposal is a parent emotion coaching skills group designed to augment FBT in the treatment of pediatric AN by arming high expressed emotion families with the skills necessary to implement FBT and improve treatment outcomes (e.g., weight restoration).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Emotion coaching skills as an augmentation to family-based therapy for adolescents with anorexia nervosa: A pilot effectiveness study with families with high expressed emotion.
    Aarnio-Peterson CM, Le Grange D, Mara CA, Modi AC, et al · · 2024 · cited 9× · PMID 38318997 · DOI 10.1002/eat.24149
  2. Mealtime challenges from the perspectives of adolescents with anorexia nervosa and atypical anorexia nervosa and their caregivers enrolled in family-based treatment.
    St Pe FA, Stevens KS, Odar Stough CC, Shaffer A, et al · · 2025 · cited 1× · PMID 39879707 · DOI 10.1016/j.eatbeh.2025.101947
  3. The Impact of Emotion Coaching on Changes in Caregiver Burden and Distress Tolerance During Family-Based Treatment.
    Kramer R, Stevens K, Mikhail ME, Le Grange D, et al · · 2026 · PMID 41603114 · DOI 10.1002/eat.70035

Verify or expand the search:

Other recruiting trials for Anorexia Nervosa

Currently open trials in the same condition.

Other Children's Hospital Medical Center, Cincinnati trials

Trials by the same sponsor.

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