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

June 2, 2026 updated by: Andrea Goldschmidt, University of Pittsburgh
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants (adolescents with AN-spectrum and their parents) are asked to complete study assessments at 5 time points: baseline and 6-, 12-, 24-, and 32-weeks after starting treatment. The 32-week time point was added approximately a year into the study, at the suggestion of the Program Officer. The research team noted that some families are still in treatment at the time of the 24-week assessment, so these data do not capture post-treatment thoughts and behaviors. To better assess post-treatment outcomes, a 32-week assessment was added to protocol.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Gateway Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Family-based treatment
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
Behavioral: Family-based treatment (FBT)
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.
Active Comparator: Integrative family therapy
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
Behavioral: Integrative family therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body mass index percentile
Time Frame: Up to 32-weeks post randomization
Adolescents will have their height and weight measured to calculate BMI percentile using CDC growth charts and accompanying procedures.
Up to 32-weeks post randomization
Eating Disorder Examination
Time Frame: Up to 32-weeks post randomization
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.
Up to 32-weeks post randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability, Appropriateness, and Feasibility of Intervention Measure
Time Frame: Up to 3 years
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.
Up to 3 years
Therapeutic Technique Scale
Time Frame: Up to 3 years
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.
Up to 3 years
Engagement
Time Frame: Up to 3 years
Percentage of potentially eligible families offered treatment who ultimately engaged in a baseline assessment visit.
Up to 3 years
Enrollment
Time Frame: Up to 3 years
Percentage of potentially eligible families who ultimately enroll in the treatment.
Up to 3 years
Abbreviated Acceptability Rating Profile
Time Frame: Up to 32-weeks post randomization
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.
Up to 32-weeks post randomization
Therapy Suitability and Patient Expectancy
Time Frame: Up to 32-weeks post randomization
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.
Up to 32-weeks post randomization
Client Satisfaction Questionnaire
Time Frame: Up to 32-weeks post randomization
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.
Up to 32-weeks post randomization
Multi-theoretical List of Therapeutic Interventions
Time Frame: Up to 32-weeks post randomization
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.
Up to 32-weeks post randomization
Attendance
Time Frame: Up to 32-weeks post randomization
Number of therapy sessions completed.
Up to 32-weeks post randomization
Completion
Time Frame: Up to 32-weeks post randomization
Percentage of families who complete a course of treatment without terminating or being withdrawn prematurely.
Up to 32-weeks post randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective Units of Distress Scale
Time Frame: Up to 32-weeks post randomization
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.
Up to 32-weeks post randomization
Parent vs. Anorexia Scale
Time Frame: Up to 32 weeks post-randomization
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.
Up to 32 weeks post-randomization
General Self Efficacy Scale
Time Frame: Up to 32 weeks post-randomization
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.
Up to 32 weeks post-randomization
Positive and Negative Affect Scale for Children
Time Frame: Up to 32 weeks post-randomization
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.
Up to 32 weeks post-randomization
Eating Disorder Symptom Impact Scale
Time Frame: Up to 32 weeks post-randomization
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.
Up to 32 weeks post-randomization
Fear of Food Measure
Time Frame: Up to 32 weeks post-randomization
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.
Up to 32 weeks post-randomization
Eating Disorder Fear Questionnaire
Time Frame: Up to 32 weeks post-randomization
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.
Up to 32 weeks post-randomization
Child & Adolescent Symptom Inventory (CASI)
Time Frame: Up to 32 weeks post-randomization
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.
Up to 32 weeks post-randomization
Child Depression Inventory (CDI)
Time Frame: Up to 32 weeks post-randomization
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.
Up to 32 weeks post-randomization
Eating Disorder Examination Questionnaire (EDE-Q)
Time Frame: Up to 32 weeks post-randomization
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.
Up to 32 weeks post-randomization
Difficulties in Emotion Regulation Scale (DERS-18)
Time Frame: Up to 32 weeks post-randomization
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.
Up to 32 weeks post-randomization
Rosenberg Self-Esteem Scale (RSES)
Time Frame: Up to 32 weeks post-randomization
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.
Up to 32 weeks post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Lifespan
Rhode Island College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea B Goldschmidt, Ph.D., The University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY22040112
  • R34MH123589 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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