Eating DisorderNCT03097874
Adaptive Treatment for Adolescent Anorexia Nervosa
A study testing Family Based Treatment and Family Based Treatment + Intensive Parental Coaching in people with Eating Disorder and Anorexia, run by Stanford University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Eating Disorder, Anorexia, Anorexia Nervosa
- What is being tested?
- Family Based Treatment and Family Based Treatment + Intensive Parental Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2017to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Francisco
San Francisco, California, 94143
Stanford University School of Medicine
Stanford, California, 94305-5723
About this study
Official title: 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.
Read the 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.
- Conditions
- Eating Disorder, Anorexia, Anorexia Nervosa, Anorexia in Adolescence, Anorexia in Children, Anorexia Nervosa Restricting Type
- Being tested
- Family Based Treatment, Family Based Treatment + Intensive Parental Coaching
- Keywords
- anorexia, anorexia nervosa, eating disorder, weight, eating, weight loss, family based treatment, FBT, family treatment, therapy, Maudsley method
- Medical subject headings
- Feeding and Eating Disorders, Anorexia, Anorexia Nervosa, Body Weight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Based TreatmentBehavioural
Also called Maudsley Method
Family Based Treatment of adolescent Anorexia Nervosa
Family Based Treatment + Intensive Parental CoachingBehavioural
Also called FBT + IPC
Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component.
| Study group | Role | What they receive |
|---|---|---|
| Family Based Treatment | Experimental | Family Based Treatment of adolescent Anorexia Nervosa Receives: 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. Receives: Behavioral: Family Based Treatment + Intensive Parental Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Body Weight (EBW)
individual with anorexia nervosa's body weight at end of treatment
Measured: following 9 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Sep 2017
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, James Dale Lock, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097874
- Sponsor's protocol ID
- 1R01MH110538
- Other IDs
- SPO 121859, 1R01MH110538-01A1
- Status last verified
- Oct 2023
- First submitted
- 22 Mar 2017
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38142046L'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.
PubMed 32116856
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirming the Efficacy/Mechanism of an Adaptive Treatment for Adolescent Anorexia
- ClinicalTrials.gov ID
- NCT03097874
- Acronym / sponsor ID
- 1R01MH110538
- Conditions
- Eating Disorder, Anorexia, Anorexia Nervosa, Anorexia in Adolescence, Anorexia in Children, Anorexia Nervosa Restricting Type
- Keywords
- anorexia, anorexia nervosa, eating disorder, weight, eating, weight loss, family based treatment, FBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Based Treatment | Experimental | Behavioral: Family Based TreatmentFamily Based Treatment of adolescent Anorexia Nervosa |
| Family Based Treatment + Intensive Parental Coaching | Experimental | Behavioral: Family Based Treatment + Intensive Parental CoachingFamily Based Treatment plus Intensive Parental Coaching if weight milestones are not met by session 4. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Based TreatmentAlso: Maudsley MethodFamily Based Treatment of adolescent Anorexia Nervosa | Behavioural | Family Based Treatment |
| Family Based Treatment + Intensive Parental CoachingAlso: FBT + IPCFamily Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component. | Behavioural | Family Based Treatment + Intensive Parental Coaching |
Primary outcome
Estimated Body Weight (EBW)
Time frame: following 9 months of treatment
individual with anorexia nervosa's body weight at end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 38142046Lock 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.
- Derived from this study: PubMed 32116856L'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Based Treatment and Family Based Treatment + Intensive Parental Coaching in people with Eating Disorder and Anorexia, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Body Weight (EBW) (time frame: following 9 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03097874, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.