Eating Disorders in Adolescence Clinical Trial
Official title:
Disseminating Eating Disorders Education and Treatment Across Multiple Levels of Care: Improving Access in the Rhode Island Medicaid Population
The goals of this project are to 1) develop training opportunities for master's-level and pre-doctoral psychology students in evidence-based assessment and treatment of adolescent EDs; 2) to provide the healthcare workforce, including licensed health professionals such as primary care physicians and behavioral health interventionists, with knowledge and competence to recognize early symptoms of and intervention strategies for EDs; and 3) to test the efficacy of delivering two evidence-based treatments for adolescent eating disorders, Family Based Treatment (FBT) and Enhanced Cognitive Behavioral Therapy (CBT-E), in the home-based setting.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion criteria include: - meets criteria for AN, atypical AN, or BN according to DSM-5 diagnostic criteria - is currently living at home - is medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., =75% of expected body weight, heartrate =50 beats per minute) - if on a psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication (8 weeks) for a co-morbid condition - speaks English - be available for long-term follow-up. Exclusion criteria include: - associated physical illness that necessitates hospitalization - psychotic illness/other mental illness requiring hospitalization - current dependence on drugs or alcohol - physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight - concurrent involvement in other psychological treatment for an eating disorder - developmental delay that would preclude participation in the intervention. |
Country | Name | City | State |
---|---|---|---|
United States | The Weight Control & Diabetes Research Center | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
The Miriam Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BMI percentile | post treatment (week 17) | ||
Primary | BMI percentile | 1 year follow up | ||
Primary | Eating disorder symptomology, as assessed by the EDE-Q. | Patient will complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Averages of the 28-item measure range from 0 to 6, with higher score indicating higher eating disorder symptomology. | post treatment (week 17) | |
Primary | Eating disorder symptomology, as assessed by the ED-15. | Patient will complete the Eating Disorder 15 (ED-15) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores from the 15-item measure range from 1 - 5, with higher scores indicating higher eating disorder symptomology. | post treatment (week 17) | |
Primary | Eating disorder symptomology, as assessed by EDE-Q | Patient will complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores of the 28-item measure range from 0 to 6, with higher score indicating higher eating disorder symptomology. | 1 year follow-up | |
Primary | Eating disorder symptomology, as assessed by ED-15. | Patient will complete the Eating Disorder 15 (ED-15) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores from the 15-item measure range from 1 - 5, with higher scores indicating higher eating disorder symptomology. | 1 year follow-up | |
Primary | Perceived efficacy of treatment, as assessed by the TSPE | One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how successful the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher perceived efficacy. | post treatment (week 17) | |
Primary | Perceived efficacy of treatment, as assessed by the CSQ | The Client Satisfaction Questionnaire (CSQ) is an 8-item measure that assesses how successful the patient perceived treatment to be. Average scores range from 1 - 4, with higher scores indicating higher satisfaction and perceived efficacy. | post treatment (week 17) | |
Primary | Perceived efficacy of treatment, as assessed by the CSQ | The Client Satisfaction Questionnaire (CSQ) is an 8-item measure that assesses how successful the patient perceived treatment to be. Average scores range from 1 - 4, with higher scores indicating higher satisfaction and perceived efficacy. | 1 year follow-up | |
Primary | Perceived efficacy of treatment, as assessed by the TSPE. | One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how successful the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher perceived efficacy. | 1 year follow-up | |
Primary | Perceived feasibility of treatment, as assessed by the TSPE. | One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how feasible the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher feasibility. | post treatment (week 17) | |
Primary | Perceived feasibility of treatment, as assessed by the CSQ. | Two items from the 8-item Client Satisfaction Questionnaire (CSQ) will assess how suitable/feasible treatment was based on the patient's needs, family dynamics, schedule constraints, etc. Average scores range from 1 - 4, with higher scores indicating higher feasibility. | post treatment (week 17) |
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