Adaptive Treatment for Adolescent Anorexia Nervosa

October 5, 2023 updated by: James Dale Lock, Stanford University

Confirming the Efficacy/Mechanism of an Adaptive Treatment for Adolescent Anorexia

The investigators are conducting a randomized controlled trial using an adaptive design for adolescents (ages 12-18) with anorexia nervosa to compare standard Family Based Treatment (FBT) to adaptive FBT with an Intensive Parental Coaching (IPC) component. If participants do not reach expected milestones by session 4 of treatment, participants may be randomized to receive additional IPC or continue treatment as usual with regular FBT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Potential subjects aged 12 to 18 with anorexia nervosa (AN) will be recruited from Stanford University, University of California, San Francisco, other bay-area medical programs and clinics, and online advertisement to the population at large. If participants are deemed eligible, participants will be invited for a baseline interview (about 2 hours in duration) during which the investigators will conduct interviews and collect questionnaire measures. Then, participants and participants' families will begin Family Based Treatment (FBT) with a study therapist at Stanford University or University of California, San Francisco, respectively. All assessments and treatments are conducted through tele-health.

At session 4, if participants have not gained 2.4kg, an indicator of early treatment response, participants and participants' families will be randomized to receive either treatment as usual (FBT) or an adaptive form of FBT, during which families will receive additional Intensive Parental Coaching (IPC). If participants have reached weight milestones (i.e., 2.4kg at session 4), participants will continue FBT as usual.

At 3 months of treatment and end of treatment, the investigators will collect the same measures taken at baseline. The investigators also ask that families participate in 6- and 12-month follow-up, respectively.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • 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 Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • Stanford, California, United States, 94305-5723
        • Stanford University School of Medicine

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

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 12-18 years of age and living with participants' families
  • meeting DSM-5 criteria for AN (both subtypes) except for the amenorrhea requirement
  • medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine.

Exclusion Criteria:

  • associated physical illness that necessitates hospitalization
  • psychotic illness, mental retardation, or any other mental illnesses that would prohibit the use of psychotherapy
  • current dependence on drugs or alcohol
  • physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • previous FBT
  • currently taking medication for co-morbid disorders that cannot be safely discontinued on a stable dose for less than 2 months
  • in the case of patients with current, or a history of sexual or physical abuse by family members, perpetrators of the abuse will be excluded from treatment.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family Based Treatment
Family Based Treatment of adolescent Anorexia Nervosa
Behavioral: Family Based Treatment
Family Based Treatment of adolescent Anorexia Nervosa
Other Names:
  • Maudsley Method
Experimental: Family Based Treatment + Intensive Parental Coaching
Family Based Treatment plus Intensive Parental Coaching if weight milestones are not met by session 4.
Behavioral: Family Based Treatment + Intensive Parental Coaching
Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component.
Other Names:
  • FBT + IPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Body Weight (EBW)
Time Frame: following 9 months of treatment
individual with anorexia nervosa's body weight at end of treatment
following 9 months of treatment

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2017

Primary Completion (Actual)

October 5, 2022

Study Completion (Actual)

October 5, 2022

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

March 31, 2017

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH110538 (U.S. NIH Grant/Contract)
  • SPO 121859 (Other Grant/Funding Number: NIH)
  • 1R01MH110538-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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