Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05184556
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2021-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R34MH123589 | NIH | None | https://reporter.nih.gov/quic… | View |