Parent Emotion Coaching for Anorexia Nervosa

NCT04421989 | Completed Results DMC

• 1 other identifier: R34MH115897
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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).

Conditions

Anorexia Nervosa; Atypical Anorexia Nervosa

Keywords

family based treatment; expressed emotion; parent coaching; adolescents

Outcome Measures

Primary Outcomes (2)

• Criticism

  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)

  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 Outcomes (1)

• Parental Warmth

  baseline, 1-month, post-treatment, and 3 month follow-up

Study Arms (2)

Emotion Coaching

EXPERIMENTAL

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

Support Group

ACTIVE COMPARATOR

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

Interventions

Emotion Coaching BEHAVIORAL

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.

Emotion Coaching

Support Group OTHER

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.

Support Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Major medical conditions affecting metabolism and/or weight
• Current substance abuse
• Moderate-profound intellectual disabilities
• Active psychosis
• Bipolar disorder
• Insulin dependent diabetes Thyroid disease

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Results Point of Contact

• Title: Dr. Claire Aarnio-Peterson
• Organization: Cincinnati Children's Hospital Medical Center

claire.aarnio-peterson@cchmc.org

5138037459

Study Officials

• Claire M Aarnio-Peterson, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: June 9, 2020
• Study Start: June 24, 2020
• Primary Completion: December 30, 2022
• Study Completion: March 23, 2023
• Last Updated: February 26, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)