Clinical trial NCT05184556: Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders
Official title: Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Eating Disorders
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Lifespan
name: Rhode Island College
First posted: 2022-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, controlled effectiveness trial will assess outcomes, implementation, and mechanisms of two psychological treatments for adolescent anorexia nervosa (AN) delivered in the home setting, in the context of community-based mental health. Adolescents with AN-spectrum disorders (n=50) and their caregivers will be randomly assigned to either family-based treatment or integrated family therapy delivered in the home. Caregivers and adolescents will provide data on weight, eating, and putative treatment mechanisms, including caregiver self-efficacy, adolescent distress, and generalizability of treatment skills. Treatment feasibility, acceptability, and appropriateness will be measured among providers and participating families. The proposed study has clear potential to advance scientific and clinical understanding of the real-world effectiveness of psychological treatments for AN, including whether adapting them for the home setting may improve accessibility and effects on treatment outcome


Eligibility criteria: Inclusion Criteria:

* Meets criteria for AN or atypical AN according to DSM-5 diagnostic criteria.
* Currently living at home with caregivers who are willing to engage in family treatment.
* 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) and receiving medical monitoring from a clinician throughout treatment.
* If on psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication for a co-morbid condition.
* Available for follow-up.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Body mass index percentile
timeFrame: Up to 24-weeks post randomization
measure: Eating Disorder Examination
timeFrame: Up to 24-weeks post randomization
Secondary outcomes:
measure: Abbreviated Acceptability Rating Profile
timeFrame: Up to 24-weeks post randomization
measure: Therapy Suitability and Patient Expectancy
timeFrame: Up to 24-weeks post randomization
measure: Acceptability, Appropriateness, and Feasibility of Intervention Measure
timeFrame: Up to 3 years
measure: Client Satisfaction Questionnaire
timeFrame: Up to 24-weeks post randomization
measure: Multi-theoretical List of Therapeutic Interventions
timeFrame: Up to 24-weeks post randomization
measure: Therapeutic Technique Scale
timeFrame: Up to 3 years
measure: Engagement
timeFrame: Up to 3 years
measure: Enrollment
timeFrame: Up to 3 years
measure: Attendance
timeFrame: Up to 24-weeks post randomization
measure: Completion
timeFrame: Up to 24-weeks post randomization
Other outcomes:
measure: Subjective Units of Distress Scale
timeFrame: Up to 24-weeks post randomization
measure: Parent vs. Anorexia Scale
timeFrame: Up to 24 weeks post-randomization
measure: General Self Efficacy Scale
timeFrame: Up to 24 weeks post-randomization
measure: Positive and Negative Affect Scale for Children
timeFrame: Up to 24 weeks post-randomization
measure: Eating Disorder Symptom Impact Scale
timeFrame: Up to 24 weeks post-randomization
measure: Fear of Food Measure
timeFrame: Up to 24 weeks post-randomization
measure: Eating Disorder Fear Questionnaire
timeFrame: Up to 24 weeks post-randomization
measure: Child & Adolescent Symptom Inventory (CASI)
timeFrame: Up to 24 weeks post-randomization
measure: Child Depression Inventory (CDI)
timeFrame: Up to 24 weeks post-randomization
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Up to 24 weeks post-randomization
measure: Difficulties in Emotion Regulation Scale (DERS-18)
timeFrame: Up to 24 weeks post-randomization
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: Up to 24 weeks post-randomization
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Pawtucket
country: United States
facility: Gateway Healthcare
state: Rhode Island
city: Providence
country: United States
facility: The Providence Center
state: Rhode Island
Study officials:
affiliation: The University of Pittsburgh
name: Andrea B Goldschmidt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: