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Parent Emotion Coaching for Anorexia Nervosa

Primary Purpose

Anorexia Nervosa, Atypical Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotion Coaching
Support Group
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring family based treatment, expressed emotion, parent coaching, adolescents

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Emotion Coaching

Support Group

Arm Description

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 + 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.

Outcomes

Primary Outcome Measures

Change in expressed emotion
Change in expressed emotion will be 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 EE using a modified version of the Family Affective Attitudes Rating Scale (FAARS), which was developed to code FMSS data in families with adolescents.
Change in percentage of median body mass index (%mBMI)
Change in %mBMI will be assessed at each time point. Weight and height will be assessed using a calibrated digital scale while wearing a hospital gown and post-void. Height will be recorded using a stadiometer. For individuals with anorexia nervosa, the %mBMI will be calculated as [current BMI] / [50th percentile BMI] x 100, using the 50th percentile BMI from the Centers for Disease Control charts for age and sex. For individuals with atypical anorexia nervosa, goal weight will be defined as change in % of return to pre-morbid weight.

Secondary Outcome Measures

Change in parental warmth
Change in parental warmth will be assessed by the Five Minute Speech Sample (see description above).

Full Information

First Posted
March 12, 2020
Last Updated
July 10, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04421989
Brief Title
Parent Emotion Coaching for Anorexia Nervosa
Official Title
Emotion Coaching Skills as an Augmentation to Family Based Treatment for Adolescents With Anorexia Nervosa: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Atypical Anorexia Nervosa
Keywords
family based treatment, expressed emotion, parent coaching, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emotion Coaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Support Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotion Coaching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Support Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in expressed emotion
Description
Change in expressed emotion will be 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 EE using a modified version of the Family Affective Attitudes Rating Scale (FAARS), which was developed to code FMSS data in families with adolescents.
Time Frame
baseline, 1-month, 3-months, and 6 months post-randomization
Title
Change in percentage of median body mass index (%mBMI)
Description
Change in %mBMI will be assessed at each time point. Weight and height will be assessed using a calibrated digital scale while wearing a hospital gown and post-void. Height will be recorded using a stadiometer. For individuals with anorexia nervosa, the %mBMI will be calculated as [current BMI] / [50th percentile BMI] x 100, using the 50th percentile BMI from the Centers for Disease Control charts for age and sex. For individuals with atypical anorexia nervosa, goal weight will be defined as change in % of return to pre-morbid weight.
Time Frame
baseline, 1-month, 3-months, and 6 months post-randomization
Secondary Outcome Measure Information:
Title
Change in parental warmth
Description
Change in parental warmth will be assessed by the Five Minute Speech Sample (see description above).
Time Frame
baseline, 1-month, 3-months, and 6 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire M Aarnio-Peterson, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Parent Emotion Coaching for Anorexia Nervosa

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