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| Name | Class |
|---|---|
| McMaster University | OTHER |
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This study examines a parent only Guided Self-Help for Family Based Treatment (GSH-FBT) for adolescents between the ages of 12 and 18 diagnosed with Anorexia Nervosa. Preliminary data collected in a previous study suggest that a Guided Parental Self-Help Version of FBT (GSH-FBT) has similar outcomes as therapist provided FBT.
In this study, families will be randomized to either receive 12 weekly online sessions of Guided Self-Help for Family Based Treatment (GSH-FBT), or 15 sessions of online, professionally delivered, standard FBT over the course of 6 months. Potential subjects will be recruited from Stanford University, McMaster University, other local 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 during which the investigators will conduct interviews and collect questionnaire measures. Participants will complete a follow-up interview at the end of treatment and 3-month after end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FBT | Active Comparator | Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. |
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| FBT-GSH | Experimental | Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Self-Help for Family Based Treatment | Behavioral | A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Number of participants enrolled in the study per month. | Assessed through the end of recruitment (about one year) |
| Treatment Retention Rate | The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT). | Up to 6 months |
| Study Retention Rate | The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment. | Up to 9 months |
| Treatment Acceptability Ratings | To assess treatment acceptability, the study used the Cooperation and Helpfulness sub-scales of the Helping Alliance Questionnaire (HAQ). The HAQ was administered to parents after session 1 and 8. The subscales, Helpfulness and Cooperation, are scored on a Likert scale from "Strongly feels it's true" (+3) to "Strongly feel it's not true" (-3). The sub-scales' total scores ranges are 15- to 15 for Helpfulness and -18 to 18 for Cooperation. A higher score indicates a better outcome. The average score was calculated if more than one parent responded. | Session 1 and Session 8 (approximately 5 minutes to complete questionnaire) |
| Treatment Acceptability Ratings | To assess treatment acceptability, the study used the Therapist Suitability and Patient Expectancy measure (TSPE). The TSPE was administered to parents after session 1. The scale is measured from 0-10 (with 0 as the lowest rating and 10 as the highest rating). The average score was calculated if more than one parent responded. A higher score on the TSPE indicates a better outcome. | Session 1 (approximately 5 minutes to complete questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| McMaster University |
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| ID | Title | Description |
|---|---|---|
| FG000 | FBT-V | Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions. |
| FG001 | GSH-FBT | Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist. Guided Self-Help for Family Based Treatment: A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | FBT-V | Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions. |
| BG001 | GSH-FBT |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Rate | Number of participants enrolled in the study per month. | Since this is a feasibility study, all enrolled and randomized participants are analyzed together to report the rate that they were recruited to the study. | Posted | Number | participants recruited per month | Assessed through the end of recruitment (about one year) |
|
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Up to approximately 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FBT-V | Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Lock | Stanford University School of Medicine | (650) 723-6643 | jimlock@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2021 | Sep 21, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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|
| Family Based Treatment | Behavioral | Standard Family Based Treatment provided for up to 15 sessions. |
|
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| Number of Treatment Sessions Attended |
The number of sessions completed by the the participant with the client in treatment is the actual, not planned, number of sessions actually conducted. |
| Through end of treatment (up to approximately 6 months) |
| Serious Adverse Events | Number of events in which a participant required hospitalization | Baseline through end of treatment period (up to 6 months) |
| Hamilton |
| Ontario |
| Canada |
Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist.
Guided Self-Help for Family Based Treatment: A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Treatment Retention Rate | The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT). | Since this is a feasibility study, all participants who were enrolled and randomized to a treatment arm are analyzed together to report the treatment retention rate. | Posted | Count of Participants | Participants | Up to 6 months |
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| Primary | Study Retention Rate | The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment. | Since this is a feasibility study, participants enrolled and randomized to a treatment arm are analyzed together to report the study retention rate. | Posted | Count of Participants | Participants | Up to 9 months |
|
|
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| Primary | Treatment Acceptability Ratings | To assess treatment acceptability, the study used the Cooperation and Helpfulness sub-scales of the Helping Alliance Questionnaire (HAQ). The HAQ was administered to parents after session 1 and 8. The subscales, Helpfulness and Cooperation, are scored on a Likert scale from "Strongly feels it's true" (+3) to "Strongly feel it's not true" (-3). The sub-scales' total scores ranges are 15- to 15 for Helpfulness and -18 to 18 for Cooperation. A higher score indicates a better outcome. The average score was calculated if more than one parent responded. | Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision). | Posted | Mean | Standard Deviation | score on a scale | Session 1 and Session 8 (approximately 5 minutes to complete questionnaire) |
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| Primary | Treatment Acceptability Ratings | To assess treatment acceptability, the study used the Therapist Suitability and Patient Expectancy measure (TSPE). The TSPE was administered to parents after session 1. The scale is measured from 0-10 (with 0 as the lowest rating and 10 as the highest rating). The average score was calculated if more than one parent responded. A higher score on the TSPE indicates a better outcome. | Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision). | Posted | Mean | Standard Deviation | score on a scale | Session 1 (approximately 5 minutes to complete questionnaire) |
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| Primary | Number of Treatment Sessions Attended | The number of sessions completed by the the participant with the client in treatment is the actual, not planned, number of sessions actually conducted. | Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision). | Posted | Mean | Standard Deviation | Sessions attended per participant | Through end of treatment (up to approximately 6 months) |
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| Primary | Serious Adverse Events | Number of events in which a participant required hospitalization | Following intent-to-treat principles, the number analyzed is based on the total N per sample in each arm, except for investigator withdrawals. | Posted | Number | events | Baseline through end of treatment period (up to 6 months) |
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| 0 |
| 20 |
| 1 |
| 20 |
| 0 |
| 20 |
| EG001 | GSH-FBT | Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist. Guided Self-Help for Family Based Treatment: A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist. | 0 | 20 | 4 | 20 | 0 | 20 |
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| HAQ - Cooperation after Session 1 |
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| HAQ - Cooperation after Session 8 |
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