Anorexia Nervosa, Atypical Anorexia Nervosa
Conditions
Keywords
family based treatment, expressed emotion, parent coaching, adolescents
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.
Interventions
BEHAVIORALEmotion 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.
OTHERSupport 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.
Sponsors
National Institute of Mental Health (NIMH)
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Criticism | baseline, 1-month (halfway through the 10-session emotion coaching intervention), post-treatment, and 3-month follow- up | 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). |
| Percent Expected Body Weight (%EBW) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Warmth | 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Emotion Coaching Participants (eligible parent/adolescent dyads) randomized to FBT + EC parent group condition received family based treatment (FBT) as part of their standard of care. In addition to FBT, parents only (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. | 44 |
| 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 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 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. | 38 |
| Total | 82 |
Baseline characteristics
| Characteristic | Emotion Coaching | Total | Support Group |
|---|---|---|---|
| Age, Categorical Adolescents <=18 years | 22 Participants | 41 Participants | 19 Participants |
| Age, Categorical Adolescents >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Adolescents Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Caregivers <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Caregivers >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Caregivers Between 18 and 65 years | 22 Participants | 41 Participants | 19 Participants |
| Age, Continuous Adolescents | 15 years STANDARD_DEVIATION 1.6 | 14.9 years STANDARD_DEVIATION 1.6 | 14.7 years STANDARD_DEVIATION 1.7 |
| Age, Continuous Caregivers | 46.4 years STANDARD_DEVIATION 6.5 | 46.3 years STANDARD_DEVIATION 6.2 | 46.2 years STANDARD_DEVIATION 6 |
| Eating Disorder Examination | 3.8 units on a scale STANDARD_DEVIATION 1.7 | 3.3 units on a scale STANDARD_DEVIATION 1.7 | 2.7 units on a scale STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Adolescents Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Adolescents Not Hispanic or Latino | 21 Participants | 40 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Adolescents Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 21 Participants | 40 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Five Minute Speech Sample Criticism Score: Coders rate caregiver's critical remarks regarding the adolescent. | 5.36 units on a scale STANDARD_DEVIATION 2.3 | 5.32 units on a scale STANDARD_DEVIATION 2 | 5.26 units on a scale STANDARD_DEVIATION 1.7 |
| Five Minute Speech Sample Warmth Score: Coders rate caregiver's positive remarks regarding the adolescent. | 5.50 units on a scale STANDARD_DEVIATION 1.7 | 5.71 units on a scale STANDARD_DEVIATION 1.7 | 5.95 units on a scale STANDARD_DEVIATION 1.8 |
| Race (NIH/OMB) Adolescents American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescents Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescents Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescents More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Adolescents Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescents Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescents White | 21 Participants | 40 Participants | 19 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers White | 22 Participants | 41 Participants | 19 Participants |
| Region of Enrollment United States | 44 participants | 82 participants | 38 participants |
| Sex: Female, Male Adolescents Female | 20 Participants | 37 Participants | 17 Participants |
| Sex: Female, Male Adolescents Male | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Caregivers Female | 22 Participants | 40 Participants | 18 Participants |
| Sex: Female, Male Caregivers Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 19 |
| other Total, other adverse events | 2 / 22 | 1 / 19 |
| serious Total, serious adverse events | 0 / 22 | 0 / 19 |
Outcome results
Primary
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).
Time frame: baseline, 1-month (halfway through the 10-session emotion coaching intervention), post-treatment, and 3-month follow- up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotion Coaching | Criticism | 1-Month | 5.5 score on a scale | Standard Deviation 2.8 |
| Emotion Coaching | Criticism | Post-Treatment | 3.7 score on a scale | Standard Deviation 2 |
| Emotion Coaching | Criticism | 3 Month Follow-Up | 2.6 score on a scale | Standard Deviation 1.6 |
| Support Group | Criticism | 1-Month | 3.7 score on a scale | Standard Deviation 2.1 |
| Support Group | Criticism | Post-Treatment | 4.3 score on a scale | Standard Deviation 2.1 |
| Support Group | Criticism | 3 Month Follow-Up | 3.1 score on a scale | Standard Deviation 2 |
Primary
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).
Time frame: baseline, 1-month, post-treatment, and 3-month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotion Coaching | Percent Expected Body Weight (%EBW) | Post-Treatment | 96.6 percentage of expected body weight | Standard Deviation 6.3 |
| Emotion Coaching | Percent Expected Body Weight (%EBW) | 3 Month Follow-up | 98.0 percentage of expected body weight | Standard Deviation 5.6 |
| Emotion Coaching | Percent Expected Body Weight (%EBW) | 1-Month | 95.1 percentage of expected body weight | Standard Deviation 7.1 |
| Support Group | Percent Expected Body Weight (%EBW) | Post-Treatment | 92.5 percentage of expected body weight | Standard Deviation 8.3 |
| Support Group | Percent Expected Body Weight (%EBW) | 3 Month Follow-up | 92.6 percentage of expected body weight | Standard Deviation 10.4 |
| Support Group | Percent Expected Body Weight (%EBW) | 1-Month | 90.8 percentage of expected body weight | Standard Deviation 7.8 |
Secondary
Parental Warmth
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).
Time frame: baseline, 1-month, post-treatment, and 3 month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Emotion Coaching | Parental Warmth | Post-Treatment | 7.8 score on a scale | Standard Deviation 0.6 |
| Emotion Coaching | Parental Warmth | 1-Month | 7.0 score on a scale | Standard Deviation 1.3 |
| Emotion Coaching | Parental Warmth | 3 Month Follow-Up | 7.4 score on a scale | Standard Deviation 1.7 |
| Support Group | Parental Warmth | Post-Treatment | 5.5 score on a scale | Standard Deviation 1.9 |
| Support Group | Parental Warmth | 3 Month Follow-Up | 7.5 score on a scale | Standard Deviation 1.6 |
| Support Group | Parental Warmth | 1-Month | 6.3 score on a scale | Standard Deviation 1.8 |