Adaptive Treatment for Adolescent Anorexia Nervosa

Sponsor

Stanford University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03097874

Collaborator

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

150

Enrollment

Locations

Arms

66.9

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Disorder Anorexia Anorexia Nervosa Anorexia in Adolescence Anorexia in Children Anorexia Nervosa Restricting Type Anorexia Nervosa, Atypical Eating Disorders in Adolescence	Behavioral: Family Based Treatment Behavioral: Family Based Treatment + Intensive Parental Coaching	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Estimated Body Weight (EBW) [following 9 months of treatment]
individual with anorexia nervosa's body weight at end of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143
2	Stanford University School of Medicine	Stanford	California	United States	94305-5723