NCT04957498

Brief Summary

This study examines a parent only Guided Self-Help for Family Based Treatment (GSH-FBT) for adolescents between the ages of 12 and 18 diagnosed with Anorexia Nervosa. Preliminary data collected in a previous study suggest that a Guided Parental Self-Help Version of FBT (GSH-FBT) has similar outcomes as therapist provided FBT.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
3 months until next milestone

Results Posted

Study results publicly available

December 13, 2021

Completed
Last Updated

June 6, 2022

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

June 29, 2021

Results QC Date

September 21, 2021

Last Update Submit

May 11, 2022

Conditions

Anorexia Nervosa

Keywords

FBTFamily Based TreatmentGuided Self-Help

Outcome Measures

Primary Outcomes (7)

  • Recruitment Rate

    Number of participants enrolled in the study per month.

    Assessed through the end of recruitment (about one year)

  • Treatment Retention Rate

    The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT).

    Up to 6 months

  • Study Retention Rate

    The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment.

    Up to 9 months

  • Treatment Acceptability Ratings

    To assess treatment acceptability, the study used the Cooperation and Helpfulness sub-scales of the Helping Alliance Questionnaire (HAQ). The HAQ was administered to parents after session 1 and 8. The subscales, Helpfulness and Cooperation, are scored on a Likert scale from "Strongly feels it's true" (+3) to "Strongly feel it's not true" (-3). The sub-scales' total scores ranges are 15- to 15 for Helpfulness and -18 to 18 for Cooperation. A higher score indicates a better outcome. The average score was calculated if more than one parent responded.

    Session 1 and Session 8 (approximately 5 minutes to complete questionnaire)

  • Treatment Acceptability Ratings

    To assess treatment acceptability, the study used the Therapist Suitability and Patient Expectancy measure (TSPE). The TSPE was administered to parents after session 1. The scale is measured from 0-10 (with 0 as the lowest rating and 10 as the highest rating). The average score was calculated if more than one parent responded. A higher score on the TSPE indicates a better outcome.

    Session 1 (approximately 5 minutes to complete questionnaire)

  • Number of Treatment Sessions Attended

    The number of sessions completed by the the participant with the client in treatment is the actual, not planned, number of sessions actually conducted.

    Through end of treatment (up to approximately 6 months)

  • Serious Adverse Events

    Number of events in which a participant required hospitalization

    Baseline through end of treatment period (up to 6 months)

Study Arms (2)

FBT

ACTIVE COMPARATOR

Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.

Behavioral: Family Based Treatment

FBT-GSH

EXPERIMENTAL

Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist.

Behavioral: Guided Self-Help for Family Based Treatment

Interventions

Guided Self-Help for Family Based TreatmentBEHAVIORAL

A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist.

Also known as: FBT-GSH
FBT-GSH
Family Based TreatmentBEHAVIORAL

Standard Family Based Treatment provided for up to 15 sessions.

Also known as: FBT
FBT

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants are 12-18 years of age
  • Participants live with a family (some families may contain only one parent)
  • Family members fluently speak and read English and have access to a computer with internet
  • Participants meet DSM-5 criteria for AN (both subtypes)
  • IBW between 75% and 88%
  • Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine
  • Participants are not engaged in another individual or family based psychotherapy trial during the duration of treatment sessions in the study.
  • Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking.

You may not qualify if:

  • Associated physical illness that necessitates hospitalization
  • Psychotic illness in any form, mental retardation, autism, or any other mental illness that would interfere with the use of psychotherapy.
  • Current dependence on drugs or alcohol
  • Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • Previous (5 or more sessions of) or current FBT-AN
  • Participants and family members do not have an adequate understanding of spoken English and are not able to speak and read English in order to participate in family therapy and the assessments.
  • Current weight is less than 75% or above 88% of expected weight given age and height.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

McMaster University

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Results Point of Contact

Title
Dr. James Lock
Organization
Stanford University School of Medicine
jimlock@stanford.edu
(650) 723-6643

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Child Psychiatry and Pediatrics in the Department of Psychiatry and Behavioral Sciences and Director of the Eating Disorder Program for Children and Adolescents

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 12, 2021

Study Start

August 1, 2019

Primary Completion

June 18, 2021

Study Completion

August 31, 2021

Last Updated

June 6, 2022

Results First Posted

December 13, 2021

Record last verified: 2022-05

Locations

CA(1)US(1)