Bullying, Trauma, Psychological, Weight, Body
Conditions
Keywords
adolescent, child, cognitive behavioral therapy, eating disorder, obesity
Brief summary
This study will perform a clinical trial with adolescents to pilot a new cognitive-behavioral treatment (CBT) for weight-related bullying testing (1) feasibility, (2) acceptability, and (3) initial efficacy. The treatment will be conducted via audio/video telehealth.
Detailed description
Youth with obesity are more likely to be bullied than healthy-weight peers and weight-related bullying is the most common form of bullying. Treating bullying during childhood could reduce immediate and long-term health consequences, but there are no established individual-level treatments for weight-related bullying despite recommendations that they could improve children's health. This study will develop and test a new treatment for adolescents (11-17 years old) who have experienced bullying due to weight. The treatment will address traumatic stress and potentially co-occurring or developing problems with unhealthy weight-control behaviors, disordered eating, and weight. The treatment will be conducted via audio/video telehealth to increase accessibility and is therefore available to anyone in the United States who meets eligibility criteria.
Interventions
BEHAVIORALCBT for Weight Bullying
Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
To be included, adolescents must: 1. Be in the age range ≥11 years old and ≤17 years old; 2. Report experiencing weight-related bullying 3. Report current distress about weight-related bullying 4. Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions); 5. Read, comprehend, and write English at a sufficient level to complete study-related materials; 6. Located in the United States and available for participation in the study for 3 months.
Exclusion criteria
Prospective participants will be excluded if the adolescent: 1. Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., severe anorexia, neurological disorder, psychotic disorders, suicidality); 2. Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension); 3. Is pregnant or breastfeeding; 4. Is taking medication(s) or participating in treatment(s) that could influence weight or appetite; 5. Is engaged in concurrent treatments that focus on trauma-related stress; 6. Began taking hormonal contraceptives less than 3 months prior; 7. Has a developmental or cognitive disorder (e.g., autism spectrum disorder); 8. Has avoidant/restrictive food intake disorder; or 9. Is participating in another clinical research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress | post (3 months) | Reductions in traumatic stress as measured by the Children's Revised Impact of Event Scale (total; scores range from 0 to 65 with higher scores indicative of more traumatic stress) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Dissatisfaction | post (3 months) | Reductions in body dissatisfaction (weight and shape dissatisfaction) as measured by the brief Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern) |
| Overvaluation | post (3 months) | Reductions in overvaluation of shape/weight as measured by the brief Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBT for Weight Bullying Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying
CBT for Weight Bullying: Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | CBT for Weight Bullying |
|---|---|
| Age, Categorical <=18 years | 28 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Body Dissatisfaction | 3.65 units on a scale STANDARD_DEVIATION 1.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Overvaluation of Shape/Weight | 3.37 units on a scale STANDARD_DEVIATION 2.13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 9 Participants |
| Stress | 27.07 units on a scale STANDARD_DEVIATION 14.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Stress
Reductions in traumatic stress as measured by the Children's Revised Impact of Event Scale (total; scores range from 0 to 65 with higher scores indicative of more traumatic stress)
Time frame: post (3 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT for Weight Bullying | Stress | 20.55 units on a scale | Standard Deviation 19.07 |
p-value: 0.047t-test, 2 sided
Secondary
Body Dissatisfaction
Reductions in body dissatisfaction (weight and shape dissatisfaction) as measured by the brief Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern)
Time frame: post (3 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT for Weight Bullying | Body Dissatisfaction | 2.85 units on a scale | Standard Deviation 2.08 |
p-value: 0.01t-test, 2 sided
Secondary
Overvaluation
Reductions in overvaluation of shape/weight as measured by the brief Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern)
Time frame: post (3 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT for Weight Bullying | Overvaluation | 1.93 units on a scale | Standard Deviation 1.83 |
p-value: <0.001t-test, 2 sided