- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04421989
Parent Emotion Coaching for Anorexia Nervosa
February 4, 2025 updated by: Children's Hospital Medical Center, Cincinnati
Emotion Coaching Skills as an Augmentation to Family Based Treatment for Adolescents With Anorexia Nervosa: A Pilot Study
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pediatric anorexia nervosa (AN) affects 400,000 adolescents in the US with devastating consequences including growth delay, bone density loss, bradycardia, and the highest mortality rate of any psychiatric condition (11.5%), with half of all deaths due to suicide.
Early intervention in adolescents is life-saving, making pediatric AN treatment an important public health concern.
The goal of pediatric AN treatment is to restore the adolescent back to a healthy weight and reverse the dangerous effects of malnutrition.
Family based treatment (FBT) is the gold standard of treatment for pediatric AN; however, 50% of patients do not respond.
The consequences of treatment non-response are dire, underscoring the importance of improving treatment via augmentations to address non-response.
One barrier to treatment response in pediatric AN is expressed emotion (EE), which is defined as a family's response to an ill patient that is characterized by hostility, critical comments, and emotional overinvolvement.
Several studies have highlighted that families with high EE undergoing treatment for their adolescent with AN have poorer outcomes, including higher drop-out rates, lack of weight restoration, and less improvement in eating disorder symptoms.
Conversely, parental warmth, a facet of EE, is associated with good outcomes in FBT.
Recent parenting interventions focused on emotion coaching (EC) to address high EE have demonstrated success as adjuncts to evidence-based treatments in other pediatric populations (e.g., PTSD, ADHD) but have not been applied to pediatric AN.
Given the detrimental effects that high EE has on the re-feeding process and the benefits of parental warmth, emotion coaching has the potential to reduce high EE, increase parental warmth, and improve weight restoration in adolescents with AN.
The aim of this R34 pilot effectiveness trial is to evaluate the effectiveness of a FBT + EC parent group intervention in families with high EE.
In Stage 1 (Feasibility Stage; Year 1), the investigators will conduct preliminary feasibility and acceptability testing of an EC parent group intervention in 6 patients with pediatric AN and their families who exhibit elevated EE.
The data from the Feasibility Stage will be used to modify session content to improve treatment delivery and the uptake of EC skills.
Once our manual is refined and finalized, the investigators will conduct a randomized controlled clinical trial (Stage 2) of 50 adolescents and their parents to compare FBT+EC parent group (n=25) versus FBT+support (n=25).
The FBT+support condition is a general parent support group that is offered as part of standard care in the CCHMC Eating Disorders Program.
FBT will be identical in both the treatment and control conditions, with the EC parent group sessions and parent support group sessions occurring separately from the FBT sessions.
If the aims of the project are achieved, this study would have a large impact on pediatric AN with the potential to improve weight restoration outcomes by augmenting FBT for families high in EE.
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
- Clinical diagnosis of AN or AAN
- Must be able to read and speak English
- Must have a caregiver participate who spends at least 50% time with participant
Exclusion Criteria
- Major medical conditions affecting metabolism and/or weight
- Current substance abuse
- Moderate-profound intellectual disabilities
- Active psychosis
- Bipolar disorder
Exclusion Criteria:
Insulin dependent diabetes Thyroid disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emotion Coaching
Participants randomized to FBT + EC parent group condition will also receive FBT as part of their standard of care.
In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations.
The EC intervention is designed to reduce expressed emotion (e.g., critical comments) and increase parental warmth.
The intervention includes emotional awareness and emotion regulation skills for parents, and emotion communication skills for parents to use with their teens undergoing FBT including active listening, emotion support, labeling emotions, and coping with emotions.
The structure of EC parent group sessions will begin with review of homework as applicable, a didactic component to teach new skills, followed by role plays between parents in the group and interventionist, and live coaching and feedback from the interventionist.
|
Participants randomized to FBT + EC parent group condition will also receive FBT as part of their standard of care.
In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations.
The EC intervention is designed to reduce expressed emotion (e.g., critical comments) and increase parental warmth.
The intervention includes emotional awareness and emotion regulation skills for parents, and emotion communication skills for parents to use with their teens undergoing FBT including active listening, emotion support, labeling emotions, and coping with emotions.
The structure of EC parent group sessions will begin with review of homework as applicable, a didactic component to teach new skills, followed by role plays between parents in the group and interventionist, and live coaching and feedback from the interventionist.
|
|
Active Comparator: Support Group
Participants randomized to FBT + Support parent group condition will also receive FBT as part of their standard of care.
In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations.
The parent support group facilitates parent discussion and support around a variety of topics central to treatment for pediatric AN including: understanding medical co-morbidities, levels of care for treatment, understanding expected body weight, navigating FMLA, and medications.
The facilitator introduces each topic weekly and opens up discussion between parents.
The facilitator's role is to ensure the group remains on topic and on time.
|
Participants randomized to FBT + Support Group parent group condition will also receive FBT as part of their standard of care.
In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations.
The support group will have a facilitator introduce each topic weekly and parents will discuss.
The facilitator's role is to ensure the group remains on topic and on time.
Weekly discussion topics include: co-morbid medical diagnoses, understanding levels of care in treatment, taking time off from work, and medications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Criticism
Time Frame: 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).
|
baseline, 1-month (halfway through the 10-session emotion coaching intervention), post-treatment, and 3-month follow- up
|
|
Percent Expected Body Weight (%EBW)
Time Frame: 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., current weight divided by Expected Body Weight).
A second coder completed the same process for double data coding.
Any discrepancies in weights entered or Expected Body Weight calculations were double checked for accuracy and entered.
Higher Percent Expected Body Weight corresponds to better outcomes (e.g., 100% = full weight restoration for individuals with anorexia nervosa).
|
baseline, 1-month, post-treatment, and 3-month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Warmth
Time Frame: 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).
|
baseline, 1-month, post-treatment, and 3 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Claire M Aarnio-Peterson, PhD, Children's Hospital Medical Center, Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 24, 2020
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
March 23, 2023
Study Registration Dates
First Submitted
March 12, 2020
First Submitted That Met QC Criteria
June 4, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 4, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH115897 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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