Emotion Coaching Skills as an Augmentation to Family Based Treatment for Adolescents With Anorexia Nervosa: A Pilot Study
Phase: NA
Conditions: Anorexia Nervosa, Atypical Anorexia Nervosa
Sponsor: Children's Hospital Medical Center, Cincinnati

 
 
 
 
 
 
 
 
 
 
 
 
 
 
STUDY TITLE: Emotion Coaching Skills as an Augmentation to Family Based Therapy for 
Adolescents with Anorexia Nervosa or Atypical Anorexia Nervosa 
NCT: NCT04421989  
DOCUMENT DATE: 8-31-2020 
 
 
 

 
 
 
CINCINNATI CHILDREN’S HOSPITAL MEDICAL CENTER 
 
STUDY PROTOCOL 
 
Study Title:  Emotion Coaching Skills as an Augmentation to Family Based Therapy for 
Adolescents with Anorexia Nervosa or Atypical Anorexia Nervosa 
 
Principal Investigator:  Claire M. Aarnio-Peterson, Ph.D. 
 
1.  ABSTRACT 
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. Atypical anorexia 
nervosa (AAN) is also associated with similar poor outcomes despite patients being at a normal 
weight. Since AAN is a new diagnosis for DSM-5, most of the outcome studies have only 
included AN. Early intervention in adolescents is lifesaving, 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 
therapy (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 (1R34MH115897-01A1) is to 
conduct a randomized controlled clinical trial of 50 adolescents and their parents to compare 
FBT+EC parent group (n=25) versus FBT+support (n=25).  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.  
 
2.  PURPOSE OF STUDY 
The purpose of this study is to establish the feasibility, acceptability, and preliminary efficacy of 
an emotion coaching skills group for parents as an adjunct to FBT for anorexia nervosa or 
atypical anorexia nervosa in adolescents. 
 
3.  BACKGROUND 
Anorexia Nervosa (AN) is associated with a host of physical and psychological problems 
and has the highest mortality rate of any psychiatric condition.1 The prevalence of AN is 
~1%, disproportionately affecting girls and young women, with boys and young men comprising 
about 10% of cases.2 The average age of onset is 15-19 years; however, incidence is 

 
increasing in young adolescents, making this a critical developmental period to study.2 Mortality 
rates range from 5.2-11.5%, with about half of deaths caused by suicide and half to 
malnutrition.3 AN is associated with severe physical health consequences affecting every major 
organ system in the body including cardiovascular, musculoskeletal, neurologic, dermatologic, 
endocrine, hematological, reproductive, and gastrointestinal.4 AN is associated with significant 
psychiatric co-morbidities including depression, anxiety disorders, with risk of suicide 18.1 times 
higher than same-age peers.1,3  
 
 FBT is the most promising evidence-based treatment for pediatric AN5-9, but 25-50% 
of patients do not respond to this intervention. In the course of AN, the neurobiological 
changes that occur secondary to malnutrition make it difficult for the adolescent to feed 
themselves, often rendering individual treatment ineffective. FBT applies a family systems 
approach and challenges the practical factors that maintain AN (e.g., allowing the adolescent to 
make their own food choices), focuses on reducing parental self-blame, and views parents as 
necessary to the success of treatment. A family meal session is utilized as an ecologically valid 
method to assess family behavior and interaction about eating at treatment entry. In the current 
project, we will conduct a family meal session at treatment entry (baseline), 1-month, 3-month, 
and 6-month time points. In the family meal session, the interventionist asks families to bring a 
typical lunch or dinner to session and observes family meal time behaviors and communication. 
The interventionist notes who is plating and serving the food, how and what the adolescent is 
eating, and how families address disordered eating at the meal (e.g., food refusal, hiding food in 
clothing, pushing food around plate) in order to assess family dynamics as well as food intake. 
Following this assessment, FBT comprises 3 phases. In Phase I, parents assume control over 
re-feeding their adolescent to weight restoration; in Phase II, control over eating is shifted back 
to the adolescent once weight is restored; Phase III goals include supporting adolescent 
autonomy and developing/maintaining appropriate parent-adolescent boundaries. The primary 
interventions in FBT are behaviorally focused: setting concrete goals for caloric intake and 
weight gain, coaching parents on how to support each other and their child through re-feeding, 
and reducing other AN-related activities, such as excessive exercise. The shift in family 
dynamics that occurs during Phase I (re-feeding) often creates significant conflict between the 
adolescent and parents. In some families, this conflict can instigate or exacerbate unhelpful 
parenting practices such as hostility and/or critical comments directed toward the adolescent. 
Although FBT is the most promising evidence-based treatment for pediatric AN, 25-50% of 
patients do not remit. One obstacle to positive treatment outcomes is that FBT does not 
explicitly provide parents with tools to navigate the conflict that is inherently created in the family 
system during FBT. Additional intervention is needed to provide parents with concrete skills so 
that parents and adolescents communicate effectively, weight restoration can be successful, 
and the cycle of AN can be broken rather than reinforced.  
 
Expressed emotion has been identified as a significant and intervenable mechanism 
predicting outcomes in pediatric AN. Early and effective intervention can prevent costly 
residential treatment and mortality for the pediatric AN population. Although several factors have 
been identified as non-specific predictors for treatment success, many are non-modifiable for 
treatment (e.g., length of illness, prior hospitalization, age).10 However, evidence is 
accumulating that expressed emotion in the family is an important factor in AN treatment. 
Expressed emotion (EE) is an umbrella term defined as caregivers’ negative attitudes and 
behaviors towards an ill family member.11 EE comprises five factors: critical comments, hostility, 
emotional overinvolvement, warmth, and positive remarks,12 and these are typically coded from 
assessments such as the Five Minute Speech Sample (FMSS). Research on EE was originally 
rooted in the schizophrenia literature, where high EE, characterized by criticism, hostility, and 

 
emotional over-involvement, is associated with higher rates of schizophrenia relapse.13 EE is 
also an important mechanism negatively impacting clinical outcomes in individuals with AN. 5 
High EE is operationalized as 1 or more critical comments, 1 or more emotional 
overinvolvement statements and/or behaviors, or both. 14Whereas the EE literature in 
schizophrenia showed a relationship between 6 or more critical comments and poor outcomes, 
even one critical comment can have negative implications for patients with AN. 15 Eleven 
empirical studies and one meta-analysis demonstrate the significant role of high parental EE 
(e.g., criticism, hostility, emotional over-involvement) in poor treatment outcomes for pediatric 
AN patients, explaining as much as 34% of variance in weight restoration.5 Further, lower 
parental EE (fewer critical comments, hostility, and emotional overinvolvement) at the baseline 
family meal session (treatment entry) is associated with early weight gain.16  
Parental warmth, a facet of EE, is significantly negatively associated with critical 
comments;17 however, it is not often assessed in treatment outcome studies. Notably, high 
parental warmth also predicts weight restoration and improved psychological functioning.18,19 For 
purposes of the current study and consistent with Caspi and colleagues, we operationalize 
parental warmth by a parent’s tone of voice, spontaneity, sympathy, and/or empathy for the 
child.17 Thus, although we acknowledge that parental warmth is a facet of EE, given that most 
studies refer to high EE as criticism, hostility, and overinvolvement, we will use the term high EE 
to refer to these constructs and parental warmth separately from this point forward.  
FBT often appears to create or exacerbate negative emotions in both parents and 
adolescents because parents are asked to take over control of re-feeding their adolescent, 
which creates significant distress and conflict in the parent-adolescent relationship. Specifically, 
FBT involves exposing the adolescent to anxiety-provoking stimuli during the refeeding process. 
In the broader family anxiety literature, parents who have difficulty responding supportively to 
their child’s anxiety or who are overly critical can disrupt or undermine the process of exposure-
based treatments.20,21 These findings appear to extend to the treatment of AN via FBT. For 
example, high levels of EE, including criticism or distress about their child’s negative emotions, 
often interferes with successful weight gain during FBT.22 Individuals with AN generally have an 
anxious temperament and tendency to be overstimulated, reflecting a neurobiological sensitivity 
to negative stimuli, such as EE, which can impede weight gain.23 In an RCT examining FBT 
versus individual therapy for pediatric AN, adolescents and their families with poor outcomes 
(i.e., below 15% expected body weight) had significantly higher EE at baseline than adolescents 
with optimal outcomes (i.e., at or above 85% expected body weight).24 While there were no 
differences in initial levels of EE between the optimal and poor outcomes groups for that trial, 
levels of EE increased from baseline to end of treatment in the poor outcomes group regardless 
of treatment type (i.e., FBT versus individual). This suggests that even if FBT therapists 
encourage parents to support their adolescent during the weight restoration process during 
FBT, families high in EE lack the skills necessary to do so. Further, the current treatment does 
not provide extensive guidance to therapists or parents on how to reduce EE. To date, the only 
accommodation to address high levels of EE in families is to conduct FBT sessions via parallel 
individual therapy (i.e., adolescent and parents seen separately).24 However, separate sessions 
are not ideal or generalizable, as parents and adolescents have to interact around meal and 
snack times at home during the re-feeding process.  
Our own preliminary data corroborate these conclusions, showing that parents who 
demonstrated an increase in critical comments, one component of EE, from baseline to end of 
treatment, or remained high in critical comments at end of treatment, were less likely to achieve 
weight gain for the adolescent compared to parents with low baseline critical comments, who 
remained low at end of treatment.22 Our preliminary data also show parents with higher baseline 
EE are less likely to have adolescents who achieve a four-pound weight gain by week four of 
FBT, an important early indicator of treatment response.25 Given the strong relationship 

 
demonstrated between early response and weight restoration at end of treatment, 25addressing 
the relationship between EE and early response is critical. 25 While 11 studies have 
demonstrated the relationship between high EE (i.e., critical comments, hostility, and emotional 
overinvolvement) and weight restoration in AN, two studies did not support EE as a mechanism 
for weight restoration. Notably, one of these studies still highlighted that high baseline EE was 
associated with treatment dropout and high baseline paternal criticism predicted less 
improvement in eating disorder symptoms post-treatment.26 The other study identified parental 
warmth, a facet of EE, as a significant mechanism of weight restoration.18 These data 
underscore the need to address high EE and parental warmth as significant mechanisms, 
particularly during eating-related interactions, to optimize the treatment for pediatric AN.  
 
 
Interventions to reduce EE and improve parental warmth show promising outcomes 
in the family-based treatment of other psychiatric diseases. Emotion coaching (EC) 
interventions are designed to reduce high EE and increase parental warmth by teaching parents 
to respond to their child’s emotions in a way that facilitates socioemotional development and 
emotional security, building on developmental theory of emotion socialization. The specific skill 
sets that are taught to parents in EC interventions, which is the focus of the current proposal, 
include active listening (e.g., eye contact, reflection, helpful questions), emotional support (e.g., 
validating emotions, expressing affection and acceptance), and emotion coaching (e.g., labeling 
emotions, identifying appropriate coping strategies). EC parenting interventions have been 
implemented to augment evidence-based, behaviorally focused interventions targeting child 
trauma,27 ADHD,28,29 and adolescent substance use prevention.30 Similar to FBT, these broader 
parenting interventions largely emphasize behavioral approaches, where the focus of treatment 
is on parents’ responses to child behavior, utilizing reinforcement and contingency management 
principles. The goal of EC interventions is to complement behavioral treatment approaches, with 
specific focus on the child’s emotional experience and emotion-related behavior, such that 
parents’ attention to and validation of their child’s emotional experience supports coaching of 
socially appropriate emotional expression. By improving supportive emotion communication, 
indicators of high EE (i.e., hostility, critical comments) would decrease, while parental warmth 
would increase. Notably, EC interventions have been conducted in families of adolescents with 
internalizing and externalizing disorders, resulting in lower rates of EE, increased warmth,31,32 
less family conflict, and less internalizing and externalizing symptoms.33 A recent study 
demonstrated efficacy of a parent EC intervention in reducing internalizing symptoms (e.g., 
anxiety), in youth transitioning to secondary school (Mchange = -4.24, SE = .91, 95% CI: -6.29, -
2.69).31 Since behavioral interventions, such as FBT, can be at odds with EC interventions (e.g., 
seeking compliance vs. supporting emotions in difficult circumstances), a feasibility trial is 
needed to effectively integrate these two approaches. We aim to target the mechanisms of high 
EE and parental warmth, through our EC-augmented FBT intervention in order to improve 
weight restoration in pediatric AN. 
 
The proposed intervention aims to address a significant gap in the pediatric AN 
treatment outcome literature by targeting previously and largely overlooked factors 
associated with poor treatment outcome: High EE and parental warmth. We will select 
families with high EE, a primary barrier to effective FBT, and provide them with augmented 
treatment to facilitate weight restoration. We are focusing on the patients/families at elevated 
risk (i.e., high EE) at baseline so that the intervention is most likely to be effective and targets 
families who need it the most. This contribution is significant because high EE is a well-
established mechanism of treatment not previously targeted in the treatment of pediatric AN. 
FBT addresses the primary task of empowering parents to restore their adolescent back to a 

 
healthy weight. However, remission rates for FBT for pediatric AN are suboptimal at 50%. 
Although the FBT treatment manual does briefly review EE and emphasizes minimizing blame 
on the patient, it does not rigorously and extensively target reducing parental criticism, hostility, 
and emotional overinvolvement (high EE) that inhibit weight restoration, or increasing parental 
warmth that might facilitate weight restoration. Thus, the proposed augmentation aims to 
improve the effectiveness of FBT by explicitly targeting the important mechanisms of high EE 
and warmth, previously neglected areas of intervention, and optimize weight restoration 
outcomes in pediatric AN (see Figure 1). If successful, this augmentation to target the identified 
mechanisms of high EE and warmth would significantly improve weight restoration outcomes. 
 
4.  STUDY DESIGN 
 We will conduct a pilot RCT of 50 
adolescents and their parents to 
compare FBT + EC parent group 
condition (n = 25) versus FBT + 
support group condition (n = 25). 
FBT will be identical in both the 
treatment and control condition (see 
Figure 1). The treatment group will 
receive 10 EC parent group sessions 
while the attention control group will 
receive 10 psychoeducation parent 
support group sessions (See Table 
1). These EC parent group and support parent group sessions will occur separately from FBT. 
Participants in both conditions will receive active intervention over a 6-month period (total of 20 
FBT sessions; 10 EC or parent support group sessions) and EE, parental warmth, and weight 
restoration will be assessed at 1, 3 and 6 months. Notably, given the recent changes to the 
ability to conduct face-to-face therapy sessions due to COVID-19, all FBT and EC sessions will 
be provided via telehealth. FBT sessions will be conducted using “Jabber” a HIPAA compliant 
telemedicine interface currently used by BMCP at CCHMC. EC sessions will be conducted via 
Zoom for Healthcare. Zoom for Healthcare allows for multiple members to be part of a group 
session in a HIPAA compliant setting. Going forward, if restrictions are lifted, FBT sessions will 
likely return to face-to-face visit types consistent with BMCP standard of care. However, for 
consistency, we will continue to conduct both EC groups and Support groups via Zoom for 
Healthcare for the entirety of the study. 
Table 1. 
Description 
of 
Intervention 
Sessions  
Session  
FBT  
Control: FBT + Parent 
Support Group  
Treatment: FBT + EC Parent Group  
Phase I  
1  
Introduce FBT and 
engage family in 
therapy, obtain history 
of how AN is affecting 
the family, obtain 
preliminary information 
 
Medical issues (low 
heart rate, labs, 
constipation) 
Review parental emotional awareness 
and emotion regulation, function of 
emotions, and family emotional climate  
Parents in charge of weight restoration 
Parents transition control over eating 
  back to adolescent 
Discuss adolescent developmental 
issues 
Figure 1. FBT 
Phase I 
(Sessions 1-10) 
Phase II 
(Sessions 11-16) 
Phase III 
(Sessions 17-20) 

 
about how the family 
functions and how this 
may promote or impede 
weight restoration  
2  
Weigh teen, discuss/ 
support parent’s efforts 
at weight restoration, 
distinguish the teen 
from the AN, modify 
family criticism of teen, 
review progress  
 
Understanding the 
different levels of care 
in ED treatment 
Parent emotional awareness and 
emotion regulation*  
*Core EC skills to be reviewed at the 
beginning of each group  
3  
Same as Session 2  
 
Taking time off from 
work to support my 
child 
Review parental emotional awareness 
and emotion regulation skills: 
mindfulness, adaptive coping, problem 
solving, relaxation  
4  
Same as Session 2  
 
Medical procedures 
when having an eating 
disorder (e.g., dental 
and wisdom teeth 
removal) 
Review parental emotional awareness 
and emotion regulation skills.  
Active Listening: Identify ways that 
parents can increase engagement in 
communication with teen  
5  
Same as Session 2  
 
Amenorrhea and 
determining expected 
body weight 
Review parental emotional awareness 
and emotion regulation skills. Emotion 
Coaching: Help the teen label and 
understand their feelings  
6  
Same as Session 2  
 
Medications 
Review parental emotional awareness 
and emotion regulation skills. Emotion 
Coaching: Ask the teen emotion-
focused questions, reinforcing 
effective coping, extending 
understanding of feelings  
7  
Same as Session 2  
 
Working with the school 
on my child’s ED  
Parent emotional awareness and 
emotion regulation  
8  
Same as Session 2  
 
How do I navigate my 
child being influenced 
by peers 
Review parental emotional awareness 
and emotion regulation skills. Emotion 
Support: Identify 
invalidating/unsupportive 
communication patterns  
9  
Same as Session 2  
 
How to ensure I have 
time for other 
children/demands at 
home 
Review parental emotional awareness 
and emotion regulation.  
Emotion Support: Identify and 
practicing validating communication  
10  
Same as Session 2  
 
Parent Q and A/wrap 
up/summary 
Review parental emotional awareness 
and emotion regulation.  
Triggers: Identify coping strategies 
when teen experiences tough 
emotions  

 
Phase II  
11-16  
Assist parents in 
negotiating the shift of 
control over eating 
back to the teen  
FBT components only  
FBT components only; no group  
Phase III  
17-20  
Discuss teen 
developmental issues  
FBT components only  
FBT components only; no group  
 
Methodology 
Screening for High EE Using the Five Minute Speech Sample (FMSS).14 The FMSS is an 
empirically validated approach for the assessment of EE, we will screen families for baseline 
levels of EE. The FMSS is derived from responses audio recorded by the parent when 
prompted to give their thoughts and feelings about their child. The FMSS has demonstrated 6-8 
week stability and concurrent validity with a semi-structured interview assessing affective 
attitudes (i.e., Camberwell Family Interview).14 Since FBT is an intensive intervention for 
families, we anticipate that EE has the potential to increase after FBT has begun. Thus, we will 
offer two potential time points for participants to qualify on the FMSS for the study: at diagnosis 
prior to starting FBT, and again halfway through Phase I of FBT (session 5). A participant that is 
a screen fail at diagnosis will be asked if they would like to be contacted again in approximately 
one month, (after session 5 of FBT) and they will be screened again with the FMSS. Any 
individual who screen fails the FMSS for the second time will be removed from our recruitment 
list and cannot participate in the study. However, individuals who screen fail at diagnosis but 
pass at the 5 session mark are eligible to participate if they meet all other eligibility criteria. 
Individuals who pass the screening process will then be sent baseline questionnaires to 
complete and scheduled for an in person or online baseline assessment to complete interviews. 
Any questionnaires not completed prior to the baseline visit will be completed at that time. 
Following the baseline visit, participants will be randomized to either the treatment or control 
condition. The randomization calculations will be conducted by the study statistician and 
managed by research staff blind to study hypotheses. See Figure 2 for RCT Design.  
 
Treatment Condition. For the treatment condition, in addition to FBT, participants will 
receive 10 additional, weekly, parent group sessions (each session is 90 minutes), within a 3-
month time frame to account for cancellations. These sessions will be conducted via Zoom 
Healthcare given the COVID-19 restrictions. Groups will be conducted via Zoom for the entirety 
of the study. Two masters level therapists will be trained to conduct this pilot effectiveness trial. 
Parents can join group as they become eligible, following an introduction to the treatment 
module, since the skills are modular and rotate. This format is also more robust for parents who 
have to miss a group session. 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. In-session feedback will be guided by observational coding sheets similar to 
those used to code EC skills at baseline and post-assessment. Between sessions, EC parents 
will be instructed to practice skills via daily 5-10 minute de-briefing with their adolescent 
following select meals or snacks. This homework will be audio-recorded daily with provided 
recorders, and parents will bring in one selected example weekly for written feedback from the 
interventionist. Further, during homework review, parents can share their de-briefing homework 
with the rest of the parents in the group to get feedback and support. Because this group will be 
offered as a specific adjunct to FBT, the interventionists will be particularly attuned to the 

 
therapeutic goals and modality of the 
FBT re-feeding process, and provide 
tailored guidance to parents on how to 
maintain effective EC skills while 
staying on track with the behavioral 
treatment, as parents may sometimes 
find the goals of emotional support and 
behavioral compliance to be at odds. In 
past pilot work, we have found that 
parents can navigate this conflict by 
validating a child’s emotion (e.g., 
anxiety) while not condoning a behavior 
(e.g., food refusal).  
Control Condition. For the control 
condition, participants will receive a 10-
week parent support group in addition to 
weekly FBT.  These sessions will occur 
via Zoom for Healthcare by two Nurse 
Care Coordinators. The session content 
is outlined in Table 1.  
 
5.   DURATION 
 
Participants will be in the study for a 
total of 6 months and an additional 6 
months is required for data 
management and analyses.  
 
6.  SELECTION & RECRUITMENT OF 
PARTICIPANTS 
Study Participants 
Study participants will include 50 
adolescents with AN and AAN between 
12-17 years old and their parents. Adolescents and their parents will be recruited during their 
initial visit in the CCHMC Eating Disorders Program medical outpatient visit, during an in-patient 
stay while medically hospitalized for complications of AN of AAN on the LA4-2 inpatient Eating 
Disorders Unit, or during their first outpatient psychotherapy visit. Given the recent face to face 
restrictions due to COVID-19, we will recruit patients via phone and/or email once their 
physician has introduced them to the study and they are interested in participating.  
 
Inclusion criteria 
 
Age 12-17 years 
 
Diagnosis of AN or AAN 
 
Have 1 or more critical comments on the Five-Minute Speech Sample (FMSS) 
 
Primary caregiver consent and adolescent assent to participate in study 
 
Primary caregiver must have at least 50% of meals with participant for FBT 
Exclusion criteria 
 
No critical comments on the FMSS 
 
Diagnosis of significant developmental disorder (e.g. Autism)  
Assessed for 
eligibility 
(n=153)
Enrollment
Randomly allocated
(anticipated n=50)
•
Baseline assessment
Refusal to 
Participate 
(n=38)
Control 
(FBT+support; n=25)
•10 sessions  (3 
months)
•1 Month Assessment
Treatment 
(FBT+EC; n=25)
•10 sessions  (3 
months)
•1 Month Assessment
Allocation
3 Months
3 Month Assessment
Control (FBT+Support
Parent Group)
• Phase 2 (Sessions 11-16)
• Phase 3 (Sessions 17-20)
Treatment (FBT+EC 
Parent Group)
• Phase 2 (Sessions 11-16)
• Phase 3 (Sessions 17-20)
6 Month Assessment
6 Months
FIGURE 2. RCT DESIGN
Ineligible (n=65)
1 Month

 
 
Inability to read and speak English due to the questionnaires and intervention 
only been developed in English 
 
significant medical co-morbidity affecting their weight including Crohn’s Disease 
or Cystic Fibrosis 
 
 
 
Recruitment Procedures  
Potential participants and their caregivers meeting eligibility criteria will be identified by a trained 
research assistant in collaboration with the members of the Eating Disorders Team. We will be 
requesting a review of health information to identify potential participants via EPIC clinic 
schedules. The research staff will review clinic schedules of medical attendings within the 
division of Adolescent Medicine to identify patients who are most likely to be eligible for the 
study based on known inclusion/exclusion criteria (e.g., age and diagnosis). This will reduce 
participant burden as we will not approach non-eligible patients. Once the physician gives 
approval, a recruitment letter will be sent to potential research participants notifying them of the 
study within 2 weeks of their upcoming appointment. If potential participants who meet eligibility 
criteria are interested in participating, a trained research assistant with significant experience 
recruiting families with adolescents with AN and AAN will contact families within 24 hours of 
their initial visit in the CCHMC Eating Disorders Program medical outpatient visit, via Jabber 
during an in-patient stay while medically hospitalized for complications of AN of AAN on the 
LA4-2 inpatient Eating Disorders Unit, or within 24 hours of their first outpatient psychotherapy 
visit. Given recent face to face restrictions due to COVID-19, we will recruit initially via phone 
after eligible participants have been seen in adolescent medicine clinic. Once face-to-face 
restrictions have lifted, we will return to face-to-face recruitment. A thorough overview of the 
study will be provided, including study procedures, benefits, and risks. All questions will be 
addressed, and an information sheet will be given. In order to determine eligibility, the Five-
Minute Speech Sample (FMSS) will be administered with a plan that the research coordinator 
will inform families of their eligibility within 2 days of the FMSS. Adolescents and their families 
who do not meet eligibility criterion based on the FMSS screening instrument will not be 
eligible to participate and no baseline visit will be set up. However, if families are willing 
to be contacted again, they have an opportunity to be screen again after session 5 of FBT 
(approximately one month later). If eligible, the research coordinator will speak with the family 
over the phone to schedule a baseline visit, complete e- consent from the caregiver or guardian, 
and e-assent from adolescents. Copies of informed consent/assent forms will be emailed to 
participants.  
Table 2. Type of Measure and Informant 
Screening 
Baseline 
Session 
1-20
1-Month 
3-Month 
6-Month 
Information Sheet 
Information for families before eligibility is determined 
P,A 
 
 
 
 
 
Five Minute Speech Sample34 
(Primary Outcome Measure) 
Research staff reads a brief prompt and then audio records 
a parent describing their child for 5 minutes. The researcher 
does not prompt or guide the caregiver during the task. 
Recordings are then transcribed and scored 
I,P, 
TD 
 
 
I,P,
TD 
I,P,
TD 
I,P,
TD 
Treatment Fidelity 
Session checklist created for study (Fidelity ≥ 90% of 
elements delivered, based on video coding 
 
 
TD 
 
 
 
EC Acceptability and Feasibility 
Questionnaire  
Measures parent and adolescent satisfaction with aspects of 
treatment 
 
 
P,A
* 
P,A 
P,A 
P,A 
Treatment Adherence: Attendance 
Total number of sessions attended (adherence>4 sessions) 
 
 
I 
 
 
 

 
 Families will then be instructed to complete baseline assessment questionnaires online through 
RedCap. The baseline visit will be conducted via Zoom for Healthcare. Families will complete a 
family meal which will be recorded and later coded, and interviews. All families will be mailed an 
audio recorder to record future EC intervention homework at this time. Families will opt in for 
text message appointment reminders. 
 
Treatment Adherence: Homework 
Completion 
Full, partial, and no completion rated (adherence ≥ 90% 
homework completed) 
 
 
I 
 
 
 
Eating Disorder Examination35 
Structured clinical interview of adolescent eating disorder 
symptoms 
 
A 
 
A 
A 
A 
Schedule for Affective Disorders 
and Schizophrenia for School 
Aged Children (6-18 years)36  
Structured diagnostic interview to assess current and past 
psychopathology in adolescents 
 
A 
 
A 
A 
A 
Strengths and Difficulties 
Questionnaire37 
Adolescent report of anxiety and depressive symptoms 
 
A 
 
A 
A 
A 
Muscularity-Oriented Eating Test 
Adolescent report of muscularity-oriented food intake 
 
A 
 
A 
A 
A 
Strengths and Difficulties 
Questionnaire- Parent Report37 
Parent report of adolescent problem behaviors, anxiety, and 
depression 
 
P 
 
P 
P 
P 
Brief Symptom Inventory38 
Parent-report of symptoms of psychopathology and distress 
 
P 
 P 
P 
P 
Emotion Regulation 
Questionnaire (ERQ)39  
Parent-report of problems with emotion regulation 
 
P,A 
 P,A 
P,A 
P,A 
The Distress Tolerance Scale40 
Parent-report of their ability to tolerate distress 
 
P 
 P 
P 
P 
Eating Disorder Symptom Impact 
Scale41 
Parent-report of caregiving burden of eating disorders with 4 
subscales: nutrition, guilt, dysregulated behavior, and social 
isolation 
 
P 
 P 
P 
P 
Parent Vs. Anorexia Scale42 
Parent-report of their level of self-efficacy in the context of 
FBT treatment for AN 
 
P 
 P 
P 
P 
Emotions as a Child Scale43 
Adolescents report on their parent’s typical responses to 
adolescent emotions, including unsupportive and supportive 
reactions 
 
A 
 A 
A 
A 
Family Meal Observational 
Assessment  
Parents and adolescents engage in a video recorded family 
meal session involving conversation about the present meal 
and meals in the last week involving happiness, sadness, 
anger, and fear. Recordings coded for parent coaching of 
adolescent emotions in response to meals. 
 
I,A,B
C,P 
 
I,A,
BC,
P 
I,A,
BC,
P 
I,A,
BC,
P 
Weekly Homework Task 
Parents are asked to practice their EC skills daily by having 
a 5-10 minute “de-briefing” of following select meals. 
Recordings coded for parent coaching of adolescent 
emotions in response to meals 
 
 
BC 
 
 
 
Encouragement of Behavioral 
Freedom44 
Adolescent report of parental encouragement of behavioral 
freedom 
 
A 
 
A 
A 
A 
Multidimensional Assessment of 
Parenting Scale45  
Parent report of parenting behaviors including proactive 
parenting, positive reinforcement, warmth, supportiveness, 
hostility, lax control, and physical control.  
 
P 
 
P 
P 
P 
Background Questionnaire 
Parent report of family demographics 
 
P 
 
P 
P 
P 
Acceptability of Intervention 
Measure 
Interventionist report of acceptability 
 
I 
I* 
I 
I 
I 
Intervention Appropriateness 
Measure 
Interventionist ratings of intervention appropriateness 
 
I 
I* 
I 
I 
I 
Feasibility of Intervention 
Measure 
Interventionist rating of feasibility of intervention 
 
I 
I* 
I 
I 
I 
Note. A = Adolescent, P = Parent 
I = Interventionist, BC = Blind Coder, TD = Treatment 
development team, *only administered after session 5 
of EC intervention 
 
 
 
 
 
 

 
7.  PROCESS OF OBTAINING CONSENT  
Prior to study enrollment, permission from the attending adolescent medicine physicians of each 
eligible participant will be obtained in clinic. As noted above, once participants are identified as 
study eligible, they will be contact within 24 hours of an initial visit in the CCHMC Eating 
Disorders Program, during an in-patient stay via Jabber, or within 24 hours of their first therapy 
visit and provided a description of the study, including study procedures, benefits, and risks, by 
the trained study coordinator included on the approved IRB protocol. Due to face-to-face 
restrictions due to COVID-19, we will initially approach potential participants via phone after 
receiving permission from their physician and sending them a recruitment letter. They will be 
given an information sheet and asked to complete the FMSS over the phone. We are asking for 
waiver of documentation of consent to perform the FMSS as this is an eligibility criterion. The 
research coordinator will inform families of their eligibility within 2 days of the FMSS over the 
phone. At this time, informed e-consent and assent will be obtained from caregivers and 
adolescents and all questions asked by participants will be addressed. Adolescents will be 
explained the study in teen-friendly terms, so they understand study procedures. Participants 
will be explicitly informed that their care at CCHMC will not be affected whether they choose to 
participate in the study or decline participation.  
 
8.  STUDY PROCEDURES  
This is a 6-month study of adolescents with AN and AAN and their caregivers. Study 
participants will complete assessment questionnaires at baseline, 1-month, 3-months, and 6-
months. Participants will be randomized to either treatment or control conditions. They will 
engage in either 10 parent EC group sessions or 10 parent support sessions over a 3-month 
period followed by a post-treatment assessment (see Table 2). 
 
Measures:  At each time point, caregivers will complete self-report measures of satisfaction 
with the intervention, parenting behaviors, psychological functioning, levels of EE, levels of 
warmth, and strategies for managing adolescent negative emotions (60 minutes to complete; 
see Table 2). Adolescents will be assessed for their level of AN or AAN symptoms using the 
gold standard for AN assessment; the EDE. Adolescents will also report on parenting behaviors 
and their own psychological functioning. These questionnaires best assess the constructs of 
interest and have good reliability and validity in pediatric AN population. The mechanisms of 
treatment outcome that we are testing are high EE and parental warmth, which will be assessed 
by the FMSS and family meal at each time point. Our outcome is adolescent weight restoration 
(≥ 95% expected body weight [EBW]). Based on prior literature, demographic, medical, and 
behavioral covariates including socioeconomic status, adolescent behavioral functioning, 
caregiver burden, and caregiver psychological and emotional functioning will be assessed in the 
current proposal. 
 
9. DATA ANALYSIS / METHODS  
 
Exploratory Aim: Examine whether the FBT+EC parent group intervention reduces 
EE, increases parental warmth, and improves weight restoration in the RCT. H1a. We will 
have preliminary evidence that families in the FBT+EC group will have lower levels of EE and 
higher parental warmth than families in the FBT+support group at 1 month which will be 
sustained at 3 and 6 months. H1b. We will have preliminary evidence that EE and parental 
warmth are correlated with weight restoration at 1, 3, and 6 months. H1c: We will have 
preliminary evidence that adolescents in the FBT+EC group will demonstrate improvements in 
weight restoration compared to children in the FBT+ parent support group at 1, 3, and 6 months. 
 

 
Exploratory Analyses: All analyses will be carried out with missing data assumed to be missing 
at random and handled via maximum likelihood estimation with auxiliary correlates68 within 
Mplus (Version 8) on the full sample (N=50). Bivariate correlations will first be calculated among 
EE, parental warmth, and weight restoration (measured continuously as mean percentage of 
EBW) at 1, 3, and 6 months (H1b). To test whether families in the FBT+EC group will have 
lower levels of EE and higher parental warmth (H1a) as well as greater improvements in weight 
restoration (H1c) than families in the FBT+support group, 3 separate ANCOVA models will be 
used to test our hypotheses for each outcome. Baseline measures of EE, parental warmth, 
parental psychopathology, length of illness, and %EBW will be included in the models as control 
covariates. 
 
Power: Although a pilot trial, Monte Carlo simulation power calculations showed that, assuming 
N=50, power will be >.80 for between group difference effects of d > 1 for all outcomes (EE, 
parental warmth, weight restoration), assuming both standardization of analysis variables and 
baseline covariates (EE, parental warmth, parental psychopathology, length of illness, and 
%EBW), which will explain (R2 = .35) 35% of response variable noise variance. 
. 
 
10. FACILITIES AND PERFORMANCE SITES  
Recruitment and all study assessments will be conducted at CCHMC. Due to face-to-face 
restrictions related to COVID-19, our initial efforts of study recruitment and study visits will be 
conducted over the phone and/or via Zoom for Healthcare which is HIPAA compliant. Data 
management will occur at CCHMC. Slack will be used as a data management tool between 
investigators at CCHMC and UGA. No protected health information will be shared over Slack. 
All study videos will be coded by Co-Investigator Anne Shaffer at University of Georgia. Video 
recorded sessions will be transferred onto OneDrive, a secure drive on the CCHMC network. 
Dr. Shaffer’s laboratory at UGA has the capacity to transfer digital video and audio to secure 
computers and DVD burners for secure physical storage of video data, supported by 
departmental and college IT services. Secure wireless connectivity is available. A dedicated 
electronics shop is provided by the University to perform routine computer repairs and software 
support is available from a full time information technology (IT) support person dedicated to this 
department. The combination of these information technologies contributes to the potential for 
success by assuring both efficient data handling and optimal communication among the 
research team.   
 
11. POTENTIAL BENEFITS  
Participants in this study may benefit from improved family communication and eating disorder 
symptoms. The study is anticipated to support preliminary efficacy of an EC parent skills group 
as an adjunct to FBT. This could lead to improvements in several outcomes for patients who 
receive the EC intervention, including reductions in expressed emotion, and improvements in 
weight restoration. These data could support continued research to refine and adapt EC 
interventions for adolescents with AN and AAN and their families.  
 
12. POTENTIAL RISKS, DISCOMFORTS, INCONVENIENCES, & PRECAUTIONS  
This is a minimal risk study, a risk that is no greater than that encountered in routine behavioral 
assessment and clinical care. There are no medical risks to study participation.  All the 
questionnaires, measures, and interviews have been used in research, including our own, 
without any reported negative effects; however, it is possible that a small group may feel 
uncomfortable responding to questions or being observed during a family meal interaction. 
 

 
Several precautions will be taken to minimize the risk, discomforts and inconveniences 
associated with this study protocol. In the unlikely event that adolescents and their families feel 
uncomfortable answering questions, they are free to skip questions or questionnaires. Families 
may prefer to not be videotaped for their assessments and they are free to opt out of recording. 
Since the EC intervention is a group, all efforts to maintain confidentiality will be made but 
cannot be guaranteed in a group setting. All participants will learn about the group and the 
importance of maintaining confidential information inside of the group setting. Outside 
relationships will be discouraged. Families may also be inconvenienced by scheduling and 
attending intervention sessions. If the adolescent or caregiver is particularly distressed, 
appropriate treatment and or referrals can be made by the PI, who is a licensed clinical 
psychologist. Notably, because a trained therapist will be interacting with participants, there is 
the possibility that confidential information will be discussed. All sessions will be audio recorded 
to ensure treatment fidelity and will be erased after review by the Research Team. See section 
14 and 15 regarding how this will be handled.  
 
If any adverse reactions or complications occur as a result of this study, we will report them per 
CCHMC policy. 
 
 
13. RISK/BENEFIT ANALYSIS  
There is minimal risk associated with study participation. Knowledge gained in this study has the 
potential to improve the treatment of pediatric AN and AAN by increasing parent emotion 
coaching skills and decreasing expressed emotion, which would improve weight restoration 
outcomes in this population.  
  
14. DATA SAFETY AND MONITORING  
We expect this study to be no more than minimal risk to participants. The research team will 
monitor for safety and adverse events at each study visit. Specifically, intervention session 
content will be discussed in weekly supervision by the interventionist with Dr. Shaffer, study Co-
I. The interventionist and research study coordinator will also complete protocol checklists for 
treatment integrity and fidelity. The research study coordinator will review questionnaires for 
completion and review of items related to significant distress or suicidal ideation. We have 
procedures in place to ensure that the research coordinator checks these items immediately 
after completion of the measure and if the items indicate risk, a clinical psychologist either with 
the eating disorder team or the PI are notified immediately to assess for further risk.  
 
If desired, administration of the assessment measures and participation will be discontinued 
at parent or patient request. The study team will provide referrals as appropriate for treatment 
needs resulting from significant adverse events or psychological issues that exceed the scope 
and/or intensity of the intervention. Adverse events will be reported to the CCHMC Institutional 
Review Board (IRB) during continuing review, while serious adverse events will be reported to 
the IRB within 24 hours.  
 
15. PRIVACY AND CONFIDENTIALITY  
We will also monitor adolescents for any adverse events per our Institutional Review Board 
(IRB) procedures and guidelines. Raw hard data will be stored in locked areas in the Division of 
Behavioral Medicine and Clinical Psychology and only authorized staff will have access to the 
computer files. Access to original data and study materials will be limited to the investigative 
team. All raw data, including questionnaires and computer files containing data will have 
confidentiality protected with the use of unique assigned study identifier codes; computer files 
will be password protected. A master file linking the identifying patient information with the study 
ID code will be secured in a password protected file. This master file will be destroyed upon 

 
completion of the study. Data will be retained until final data analyses are completed; all de-
identified data will then be shredded and destroyed. Neither names nor identifying information 
will appear in any publication based on this research. All audio files will be password protected 
and then deleted after they have been reviewed by the PI for treatment fidelity.  
 
Confidentiality will be retained throughout the study related to intervention content, with one 
exception. If the participant provides information about something that might put the participant 
or another person in danger, we are obligated to report this as mandated reporters. This will be 
shared in the consent/assent form.   
 
All study personnel have been trained in data safety and monitoring, privacy and confidentiality, 
minimizing risks related to loss of privacy and confidentiality. We will closely monitor 
performance of our research personnel to ensure the strictest standards. Study personnel will 
screen questionnaires for completeness and participants will be encouraged to complete 
missing items. If there are any elevations on risk-items, the PI will be immediately notified and 
will ensure that risk is assessed by either a licensed psychologist or a master’s level licensed 
therapist. Data from each questionnaire will be entered into a Redcap database and then 
analyzed with SAS, Mplus, or SPSS. 
 
Because this research study involves payment for participation, we are required by Internal 
Revenue Service (IRS) rules to collect and use participant’s social security number (SSN) or 
taxpayer identification number (TIN) in order to track the amount of money that we pay them. 
Unless they have given specific permission for another use of their SSN or TIN related to this 
research study, we will only use their SSN or TIN to keep track of how much money we pay 
them and their SSN or TIN will not be used as part of this research study. 
 
16. COST OF PARTICIPATION 
There are no costs for participation in this research study. Participants will be responsible for the 
usual costs of medical care. 
 
17. PAYMENT FOR PARTICIPATION  
Participants will complete 10 EC group sessions, baseline assessments, and post-treatment 
assessments. Adolescents can earn $100 and caregivers $100 for their participation ($25 at 
each of the 4-assessments). Families can choose to have separate ClinCards or can be paid on 
one ClinCard together. If they miss one of the 4 assessments, they will not be paid for the one 
they miss. 
 
We will give participants their payment in the form of a reloadable debit card (ClinCard) and they 
will receive a handout that will explain how to use this card. We will provide them with a card, 
and we will load money onto their card after completion of the baseline visit and after completion 
of the post treatment visit.  
 
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