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| ID | Type | Description | Link |
|---|---|---|---|
| SPO 121859 | Other Grant/Funding Number | NIH | |
| 1R01MH110538-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family Based Treatment | Experimental | Family Based Treatment of adolescent Anorexia Nervosa |
|
| Family Based Treatment + Intensive Parental Coaching | Experimental | Family Based Treatment plus Intensive Parental Coaching if weight milestones are not met by session 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family Based Treatment | Behavioral | Family Based Treatment of adolescent Anorexia Nervosa |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Body Weight (EBW) | individual with anorexia nervosa's body weight at end of treatment | following 9 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38142046 | Derived | 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. | |
| 32116856 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2021 | Oct 5, 2023 |
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| Family Based Treatment + Intensive Parental Coaching | Behavioral | Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component. |
|
|
| Stanford |
| California |
| 94305-5723 |
| United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D000855 | Anorexia |
| D000856 | Anorexia Nervosa |
| D001835 | Body Weight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001836 | Body Weight Changes |
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