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Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders

Primary Purpose

Anorexia Nervosa, Eating Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-based treatment (FBT)
Integrative family therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of PittsburghRecruiting
  • Gateway HealthcareRecruiting
  • The Providence CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family-based treatment

Integrative family therapy

Arm Description

Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care

Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care

Outcomes

Primary Outcome Measures

Body mass index percentile
Adolescents will have their height and weight measured to calculate BMI percentile using CDC growth charts and accompanying procedures.
Eating Disorder Examination
The Eating Disorder Examination will be used to diagnose anorexia nervosa, and assess eating disorder behaviors, attitudes, and cognitions. Items are scored from 0-7 and averaged to create subscales reflecting restraint, eating concerns, shape concerns, weight concerns, and global eating-related psychopathology. Higher scores indicate more severe eating disorder symptoms.

Secondary Outcome Measures

Abbreviated Acceptability Rating Profile
The Abbreviated Acceptability Rating Profile is an 8-item questionnaire that assesses acceptability of treatment from both parent and child viewpoints on a 6-point Likert scale. Higher scores reflect greater levels of treatment acceptability.
Therapy Suitability and Patient Expectancy
The Therapy Suitability and Patient Expectancy is used to assess patients' and caregivers' perceptions of treatment suitability and expected improvement with treatment from 0 (not at all) to 10 (extremely) using 2 items. Higher scores reflect more positive expectations from treatment.
Acceptability, Appropriateness, and Feasibility of Intervention Measure
The Acceptability, Appropriateness, and Feasibility of Intervention Measure is a 31-item survey comprising three subscales (acceptability, appropriateness, and feasibility) that will assess clinician perspectives of treatment. Higher scores reflect greater perceived acceptability, appropriateness, and feasibility.
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire-8 is an 8-item questionnaire that assesses satisfaction with treatment on a 4-point Likert scale, with higher scores indicating higher treatment satisfaction.
Multi-theoretical List of Therapeutic Interventions
The Multi-theoretical List of Therapeutic Interventions assesses different therapeutic techniques occurring across different forms of psychotherapy. The MULTI-60 comprises 8 subscales representing 8 primary therapeutic orientations, including cognitive-behavioral and dialectic-behavioral therapy. Items are rated from 1-5, with higher scores indicating that a given technique is more typical of the overall treatment approach.
Therapeutic Technique Scale
The Therapeutic Technique Scale assesses clinician implementation of 17 therapeutic techniques to measure treatment fidelity. Items are rated from 0-5, with higher scores indicating a greater level of skill in implementing each therapeutic technique in therapy sessions.
Engagement
Percentage of potentially eligible families offered treatment who ultimately engaged in a baseline assessment visit.
Enrollment
Percentage of potentially eligible families who ultimately enroll in the treatment.
Attendance
Number of therapy sessions completed.
Completion
Percentage of families who complete a course of treatment without terminating or being withdrawn prematurely.

Full Information

First Posted
December 1, 2021
Last Updated
July 24, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH), Lifespan, Rhode Island College
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1. Study Identification

Unique Protocol Identification Number
NCT05184556
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH), Lifespan, Rhode Island College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Eating Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Family-based treatment
Arm Type
Experimental
Arm Description
Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care
Arm Title
Integrative family therapy
Arm Type
Active Comparator
Arm Description
Families will complete 2-6 hours of therapy per week for 10 - 32 weeks, on average, determined by clinical need in conjunction with insurance specifications related to coverage of home-based care
Intervention Type
Behavioral
Intervention Name(s)
Family-based treatment (FBT)
Intervention Description
FBT is a structured behavioral treatment focused on empowering caregivers to take charge of the adolescent's eating behavior and return him/her to a normative weight and developmental trajectory. FBT involves three consecutive phases: 1) caregivers are fully in control of the adolescent's eating; 2) control of eating is gradually returned to the adolescent; and 3) developmental issues are explored. In the current study, FBT is adapted for delivery in the home setting in the following ways: intensified dose of treatment (2-6 hours of therapy per week over 10 - 32 weeks); use of clinician as an additional support to the family; multiple family meals in the home and community; sociocultural tailoring; and inclusion of supplemental individual work with the adolescent to improve emotion regulation/distress tolerance.
Intervention Type
Behavioral
Intervention Name(s)
Integrative family therapy
Intervention Description
The integrated family therapy approach includes psychoeducation, supportive family therapy, and elements of cognitive-behavioral interventions. Families may be referred for additional nutritional counseling and prescribed a meal plan as indicated. Typical strategies include educating families on the presentation and prognosis of adolescent AN; identifying dysfunctional family structures/alliances and communication patterns; using reflective listening to engage and validate family members; challenging maladaptive beliefs about eating and weight; and supporting families in developing strategies for management of both general and eating disorder-specific distress. Treatment is generally non-directive.
Primary Outcome Measure Information:
Title
Body mass index percentile
Description
Adolescents will have their height and weight measured to calculate BMI percentile using CDC growth charts and accompanying procedures.
Time Frame
Up to 24-weeks post randomization
Title
Eating Disorder Examination
Description
The Eating Disorder Examination will be used to diagnose anorexia nervosa, and assess eating disorder behaviors, attitudes, and cognitions. Items are scored from 0-7 and averaged to create subscales reflecting restraint, eating concerns, shape concerns, weight concerns, and global eating-related psychopathology. Higher scores indicate more severe eating disorder symptoms.
Time Frame
Up to 24-weeks post randomization
Secondary Outcome Measure Information:
Title
Abbreviated Acceptability Rating Profile
Description
The Abbreviated Acceptability Rating Profile is an 8-item questionnaire that assesses acceptability of treatment from both parent and child viewpoints on a 6-point Likert scale. Higher scores reflect greater levels of treatment acceptability.
Time Frame
Up to 24-weeks post randomization
Title
Therapy Suitability and Patient Expectancy
Description
The Therapy Suitability and Patient Expectancy is used to assess patients' and caregivers' perceptions of treatment suitability and expected improvement with treatment from 0 (not at all) to 10 (extremely) using 2 items. Higher scores reflect more positive expectations from treatment.
Time Frame
Up to 24-weeks post randomization
Title
Acceptability, Appropriateness, and Feasibility of Intervention Measure
Description
The Acceptability, Appropriateness, and Feasibility of Intervention Measure is a 31-item survey comprising three subscales (acceptability, appropriateness, and feasibility) that will assess clinician perspectives of treatment. Higher scores reflect greater perceived acceptability, appropriateness, and feasibility.
Time Frame
Up to 3 years
Title
Client Satisfaction Questionnaire
Description
The Client Satisfaction Questionnaire-8 is an 8-item questionnaire that assesses satisfaction with treatment on a 4-point Likert scale, with higher scores indicating higher treatment satisfaction.
Time Frame
Up to 24-weeks post randomization
Title
Multi-theoretical List of Therapeutic Interventions
Description
The Multi-theoretical List of Therapeutic Interventions assesses different therapeutic techniques occurring across different forms of psychotherapy. The MULTI-60 comprises 8 subscales representing 8 primary therapeutic orientations, including cognitive-behavioral and dialectic-behavioral therapy. Items are rated from 1-5, with higher scores indicating that a given technique is more typical of the overall treatment approach.
Time Frame
Up to 24-weeks post randomization
Title
Therapeutic Technique Scale
Description
The Therapeutic Technique Scale assesses clinician implementation of 17 therapeutic techniques to measure treatment fidelity. Items are rated from 0-5, with higher scores indicating a greater level of skill in implementing each therapeutic technique in therapy sessions.
Time Frame
Up to 3 years
Title
Engagement
Description
Percentage of potentially eligible families offered treatment who ultimately engaged in a baseline assessment visit.
Time Frame
Up to 3 years
Title
Enrollment
Description
Percentage of potentially eligible families who ultimately enroll in the treatment.
Time Frame
Up to 3 years
Title
Attendance
Description
Number of therapy sessions completed.
Time Frame
Up to 24-weeks post randomization
Title
Completion
Description
Percentage of families who complete a course of treatment without terminating or being withdrawn prematurely.
Time Frame
Up to 24-weeks post randomization
Other Pre-specified Outcome Measures:
Title
Subjective Units of Distress Scale
Description
The Subjective Units of Distress Scale is a widely-used therapeutic and clinical tool used to measure state anxiety, typically in the context of therapy or treatment sessions. Distress is rated on a 0-100 scale with higher scores reflecting greater state anxiety/distress.
Time Frame
Up to 24-weeks post randomization
Title
Parent vs. Anorexia Scale
Description
The Parent vs. Anorexia Scale measures parental self-efficacy in relation to adolescent eating disorders via 7 items on a 4-point Likert scale. Higher scores indicate higher self-efficacy.
Time Frame
Up to 24 weeks post-randomization
Title
General Self Efficacy Scale
Description
The General Self Efficacy Scale is a 10-item survey that assess perceived general self-efficacy across a broad range of stressful or challenging demands. Items are rated from 1-4, with higher scores reflect greater self-efficacy.
Time Frame
Up to 24 weeks post-randomization
Title
Positive and Negative Affect Scale for Children
Description
The Positive and Negative Affect Scale for Children is a 30-item self-report measure of positive and negative affect. Items are rated from 1-5 with higher scores reflecting more intense emotions.
Time Frame
Up to 24 weeks post-randomization
Title
Eating Disorder Symptom Impact Scale
Description
The Eating Disorder Symptom Impact Scale is a 24-item questionnaire that measures carers' perceptions of the emotional, psychological, and tangible impact of caring for someone with an eating disorder. 50 Items are measured on a 5-point Likert scale with higher scores indicating higher perceived burden during the previous month. The measure comprises five subscales measuring burden related to guilt, confrontational behaviors, binge-purge difficulties, mealtime difficulties, and illness awareness.
Time Frame
Up to 24 weeks post-randomization
Title
Fear of Food Measure
Description
The Fear of Food Measure is a 33-item scale assessing mealtime anxiety using 3 subscales: anxiety about eating, food avoidance behavior, and feared concerns. Items are scored from 1-7 with higher scores reflecting greater fear of food.
Time Frame
Up to 24 weeks post-randomization
Title
Eating Disorder Fear Questionnaire
Description
The Eating Disorder Fear Questionnaire assesses eating disorder-related fears and anxieties, specifically towards food and weight/shape. It includes 20 items scored from 1-7, with higher scores reflecting greater eating disorder-related fears.
Time Frame
Up to 24 weeks post-randomization
Title
Child & Adolescent Symptom Inventory (CASI)
Description
The Child & Adolescent Symptom Inventory (CASI) parent-version will be used to identify potential psychiatric co-morbidities. The CASI combines two well-developed and widely-used scales, the Child Symptom Inventory (CSI) and Adolescent Symptom Inventory (ASI) to assess common mental and behavioral disordered in children ages 5 - 18. Symptoms are scored on a scale of 0 (never) to 3 (very often), with higher scores indicating more severe symptoms of psychiatric co-morbidities.
Time Frame
Up to 24 weeks post-randomization
Title
Child Depression Inventory (CDI)
Description
The CDI is a widely-used measure for assessing depressive symptoms in youth. The CDI is well-established in terms of its test-retest reliability, internal consistency, and construct validity. It has been found to correlate modestly with clinician reports of depression, and to distinguish between children with depression and those with other forms of psychopathology. Items are scored from 1 to 3, with higher scores indicating more depressive symptoms.
Time Frame
Up to 24 weeks post-randomization
Title
Eating Disorder Examination Questionnaire (EDE-Q)
Description
The Eating Disorder Examination-Questionnaire is a self-report questionnaire assessing eating pathology, including dietary restraint, and concerns about eating, shape, and weight. The EDE-Q assesses the frequency and severity of diagnostic symptoms of eating disorders using 4 subscales: restraint, eating concern, shape concern, and weight concern. Higher subscale and global scores indicate higher frequency and severity of eating disorder symptomology.
Time Frame
Up to 24 weeks post-randomization
Title
Difficulties in Emotion Regulation Scale (DERS-18)
Description
The DERS-18 is a self-report 18-item measure of emotion regulation abilities. The scale is rated on a 5-point Likert scale from "almost never" to "almost always", with higher scores indicating higher emotion dysregulation. It is found to have good reliability and validity.
Time Frame
Up to 24 weeks post-randomization
Title
Rosenberg Self-Esteem Scale (RSES)
Description
The Rosenberg Self-Esteem Scale is a child-reported measure of global self-esteem. Scores range from 0-30, with higher scores indicating higher self-esteem. The RSE has good reliability and validity in youth samples.
Time Frame
Up to 24 weeks post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Stalvey, B.S.
Phone
4125869066
Email
stalveyer@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dayna Winograd, B.S.
Phone
4017938969
Email
dwinograd@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea B Goldschmidt, Ph.D.
Organizational Affiliation
The University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Stalvey, B.S.
Email
stalveyer@upmc.edu
First Name & Middle Initial & Last Name & Degree
Andrea B Goldschmidt
Facility Name
Gateway Healthcare
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deidre Donaldson, Ph.D.
First Name & Middle Initial & Last Name & Degree
Genesis Jimenez, B.S.
Phone
401-585-1137
Email
GJimenez@Lifespan.org
First Name & Middle Initial & Last Name & Degree
Deidre Donaldson
Facility Name
The Providence Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothy Carter, M.S./R.N.
First Name & Middle Initial & Last Name & Degree
Genesis Jimenez, B.S.
Phone
401-585-1137
Email
GJimenez@Lifespan.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Research data from participants will be shared with the broader scientific community through the NIMH Data Archive and the National Database for Clinical Trials related to Mental Illness. Data will be de-identified and harmonized to a common standard. Data will include all adolescent-, caregiver-, and clinician-level variables reflecting eating- and weight-related outcomes, implementation metrics, and treatment mechanisms, and will be accompanied by a data dictionary describing the variables, data structure, and any relevant coding/re-coding schemes. Data will be uploaded at least every six months for the duration of the study. All informed consent/assent documents will include a discussion of how data will be shared with the Data Archive and the research community.
IPD Sharing Time Frame
Data will be uploaded at least every 6 months for the duration of the 3-year study.
IPD Sharing Access Criteria
We will make data and documentation available only under a data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed; and (4) a commitment not to attempt to identify participants individually.

Learn more about this trial

Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders

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