Trial Outcomes & Findings for Parent Emotion Coaching for Anorexia Nervosa (NCT NCT04421989)

NCT ID: NCT04421989

Last Updated: 2025-02-26

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

baseline, 1-month (halfway through the 10-session emotion coaching intervention), post-treatment, and 3-month follow- up

Results posted on

2025-02-26

Participant Flow

Participants were excluded from the study before assignment to groups if their caregiver did not screen high in expressed emotion on the Five Minute Speech Sample.

Participant milestones

Participant milestones
Measure	Emotion Coaching Participants (eligible parent/adolescent dyads) randomized to FBT + EC parent group condition received FBT as part of their standard of care. In addition to FBT, parents (alone without adolescents present) received 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 begins 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.	Support Group Participants (eligible parent/adolescent dyads) randomized to FBT + Support parent group condition received family based treatment (FBT) as part of their standard of care. In addition to FBT, parents only (without the adolescent) received 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.
Overall Study STARTED	22	19
Overall Study COMPLETED	11	14
Overall Study NOT COMPLETED	11	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data characterizes n = 22 adolescents and their primary caregivers (n = 22) in the Emotion Coaching group and n = 19 adolescents and their primary caregivers (n = 19) in the Support group.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: baseline, 1-month (halfway through the 10-session emotion coaching intervention), post-treatment, and 3-month follow- up

Outcome measures

Outcome measures
Measure	Emotion Coaching n=11 Participants 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.	Support Group n=14 Participants 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. 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.
Criticism 3 Month Follow-Up	2.6 score on a scale Standard Deviation 1.6	3.1 score on a scale Standard Deviation 2.0
Criticism 1-Month	5.5 score on a scale Standard Deviation 2.8	3.7 score on a scale Standard Deviation 2.1
Criticism Post-Treatment	3.7 score on a scale Standard Deviation 2.0	4.3 score on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Emotion Coaching n=11 Participants 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.	Support Group n=14 Participants 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. 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.
Percent Expected Body Weight (%EBW) 1-Month	95.1 percentage of expected body weight Standard Deviation 7.1	90.8 percentage of expected body weight Standard Deviation 7.8
Percent Expected Body Weight (%EBW) Post-Treatment	96.6 percentage of expected body weight Standard Deviation 6.3	92.5 percentage of expected body weight Standard Deviation 8.3
Percent Expected Body Weight (%EBW) 3 Month Follow-up	98.0 percentage of expected body weight Standard Deviation 5.6	92.6 percentage of expected body weight Standard Deviation 10.4

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Emotion Coaching n=11 Participants 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.	Support Group n=14 Participants 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. 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.
Parental Warmth 1-Month	7.0 score on a scale Standard Deviation 1.3	6.3 score on a scale Standard Deviation 1.8
Parental Warmth Post-Treatment	7.8 score on a scale Standard Deviation 0.6	5.5 score on a scale Standard Deviation 1.9
Parental Warmth 3 Month Follow-Up	7.4 score on a scale Standard Deviation 1.7	7.5 score on a scale Standard Deviation 1.6

Adverse Events

Emotion Coaching

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Support Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Emotion Coaching n=22 participants at risk 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.	Support Group n=19 participants at risk 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. 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.
Psychiatric disorders Suicidal Ideation	9.1% 2/22 • Number of events 2 • Each adolescent participant was in the study for a duration of 6 months (from consent until follow up assessment). Adverse events were tracked for adolescent participants only. Caregivers were not monitored/assessed for Adverse Events	0.00% 0/19 • Each adolescent participant was in the study for a duration of 6 months (from consent until follow up assessment). Adverse events were tracked for adolescent participants only. Caregivers were not monitored/assessed for Adverse Events
Psychiatric disorders Acute Food Refusal	0.00% 0/22 • Each adolescent participant was in the study for a duration of 6 months (from consent until follow up assessment). Adverse events were tracked for adolescent participants only. Caregivers were not monitored/assessed for Adverse Events	5.3% 1/19 • Number of events 1 • Each adolescent participant was in the study for a duration of 6 months (from consent until follow up assessment). Adverse events were tracked for adolescent participants only. Caregivers were not monitored/assessed for Adverse Events

Additional Information

Dr. Claire Aarnio-Peterson

Cincinnati Children's Hospital Medical Center

Phone: 5138037459

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place