NCT03097874

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

5.1 years

First QC Date

March 22, 2017

Last Update Submit

October 5, 2023

Conditions

Eating DisorderAnorexiaAnorexia NervosaAnorexia in AdolescenceAnorexia in ChildrenAnorexia Nervosa Restricting TypeAnorexia Nervosa, AtypicalEating Disorders in Adolescence

Keywords

anorexiaanorexia nervosaeating disorderweighteatingweight lossfamily based treatmentFBTfamily treatmenttherapyMaudsley method

Outcome Measures

Primary Outcomes (1)

  • Estimated Body Weight (EBW)

    individual with anorexia nervosa's body weight at end of treatment

    following 9 months of treatment

Study Arms (2)

Family Based Treatment

EXPERIMENTAL

Family Based Treatment of adolescent Anorexia Nervosa

Behavioral: Family Based Treatment

Family Based Treatment + Intensive Parental Coaching

EXPERIMENTAL

Family Based Treatment plus Intensive Parental Coaching if weight milestones are not met by session 4.

Behavioral: Family Based Treatment + Intensive Parental Coaching

Interventions

Family Based TreatmentBEHAVIORAL

Family Based Treatment of adolescent Anorexia Nervosa

Also known as: Maudsley Method
Family Based Treatment
Family Based Treatment + Intensive Parental CoachingBEHAVIORAL

Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component.

Also known as: FBT + IPC
Family Based Treatment + Intensive Parental Coaching

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford University School of Medicine

Stanford, California, 94305-5723, United States

Location

Related Publications (2)

  • Lock JD, Le Grange D, Bohon C, Matheson B, Jo B. Who Responds to an Adaptive Intervention for Adolescents With Anorexia Nervosa Being Treated With Family-Based Treatment? Outcomes From a Randomized Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2024 Jun;63(6):605-614. doi: 10.1016/j.jaac.2023.10.012. Epub 2023 Dec 21.

    PMID: 38142046DERIVED

  • L'Insalata A, Trainor C, Bohon C, Mondal S, Le Grange D, Lock J. Confirming the Efficacy of an Adaptive Component to Family-Based Treatment for Adolescent Anorexia Nervosa: Study Protocol for a Randomized Controlled Trial. Front Psychiatry. 2020 Feb 12;11:41. doi: 10.3389/fpsyt.2020.00041. eCollection 2020.

    PMID: 32116856DERIVED

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexiaAnorexia NervosaBody WeightWeight Loss

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 22, 2017

First Posted

March 31, 2017

Study Start

September 1, 2017

Primary Completion

October 5, 2022

Study Completion

October 5, 2022

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)