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Parent Emotion Coaching for Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT04421989
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Claire Aarnio-Peterson, Children's Hospital Medical Center, Cincinnati

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).

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Atypical Anorexia Nervosa Behavioral: Emotion Coaching Other: Support Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Emotion Coaching Skills as an Augmentation to Family Based Treatment for Adolescents With Anorexia Nervosa: A Pilot Study
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : May 1, 2022

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.
Behavioral: 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.

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.
Other: Support Group
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 Measures :
  1. Change in expressed emotion [ Time Frame: baseline, 1-month, 3-months, and 6 months post-randomization ]
    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.

  2. Change in percentage of median body mass index (%mBMI) [ Time Frame: baseline, 1-month, 3-months, and 6 months post-randomization ]
    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 :
  1. Change in parental warmth [ Time Frame: baseline, 1-month, 3-months, and 6 months post-randomization ]
    Change in parental warmth will be assessed by the Five Minute Speech Sample (see description above).



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421989


Contacts
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Contact: Claire M Aarnio-Peterson, PhD 513-803-7459 claire.aarnio-peterson@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Emily Offenbacker, BS       Emily.offenbacker@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Claire M Aarnio-Peterson, PhD Children's Hospital Medical Center, Cincinnati
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Responsible Party: Claire Aarnio-Peterson, Assistant Professor, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04421989    
Other Study ID Numbers: R34MH115897 ( U.S. NIH Grant/Contract )
R34MH115897 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Claire Aarnio-Peterson, Children's Hospital Medical Center, Cincinnati:
family based treatment
expressed emotion
parent coaching
adolescents
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders