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Multifamily Guided Self-Help Family-Based Treatment (MF-GSH-FBT) (MF-GSH-FBT)

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-Family Guided Self-Help FBT
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adolescent participants are 12-17 years of age
  2. Adolescent participants live with a family (some families may contain only one parent)
  3. Family members fluently speak and read English and have access to a computer with internet
  4. Adolescent participants meet DSM-5 criteria for AN
  5. Adolescent participants' IBW above 75%
  6. Adolescent participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine

Exclusion Criteria:

  1. Associated physical illness in any form that necessitates hospitalization of the adolescent with Anorexia
  2. Psychotic illness in any form, mental retardation, autism, or any other mental illness in the adolescent or parents/ carers that would interfere with the use of psychotherapy.
  3. Current dependence on drugs or alcohol in adolescent or parents.
  4. Physical conditions (e.g. diabetes mellitus, pregnancy) in adolescent known to influence eating or weight
  5. Participants and family members do not have an adequate understanding of spoken English and are not able to speak and read English in order to participate in family therapy and the assessments.
  6. Current weight is less than 75% of expected weight given age and height.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multifamily Guided Self-Help Family-Based Treatment (MF-GSH-FBT)

Arm Description

Treatment consists of up to 12 once-weekly online group sessions, where groups are made up of parents from 4-5 different families of young people with Anorexia. Group sessions will last approximately 50-60 minutes. Prior to each group session, parents watch recorded videos about how parents can help their child with Anorexia. Only parents, and not the young person with Anorexia, attend the group sessions.

Outcomes

Primary Outcome Measures

Recruitment Rate
Number of participants enrolled in the study per month.
Number of Treatment Sessions Attended
Treatment Retention Rate
The count of participants who did not stop treatment before finishing the 12-session parent groups
Treatment Acceptability as Measured by Helping Alliance Questionnaire
The Helping Alliance Questionnaire (HAQ) is an 11-item questionnaire that measures the quality of the therapist-patient relationship and will be completed by parents.
Treatment Acceptability as Measured by Therapy Suitability and Patient Expectancy questionnaire
The Therapy Suitability and Patient Expectancy (TSPE) measures perceptions of the suitability and expectancy of the treatment provided and will be rated by parents.

Secondary Outcome Measures

Eating Disorder Cognitions
Eating Disorder Examination (EDE): This is a standardized measure that measures the severity of the characteristic psychopathology of eating disorders. It is to be administered by assessor to the adolescent with Anorexia at baseline and EOT.
Expected Body Weight
Expected Body Weight (EBW) percentages for the adolescent with Anorexia will be calculated using Center for Disease Control metrics in children and adolescents.

Full Information

First Posted
June 21, 2022
Last Updated
October 20, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05446038
Brief Title
Multifamily Guided Self-Help Family-Based Treatment (MF-GSH-FBT)
Acronym
MF-GSH-FBT
Official Title
Feasibility, Acceptability, and Preliminary Efficacy of an Online Multifamily Guided Self-Help Family-Based Treatment (FBT) Group for Parents of Adolescents With Anorexia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 20, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a study testing whether an online Multifamily Guided Self-Help Family Based Treatment (FBT) for Anorexia Nervosa in adolescents aged 12 to 17 is acceptable and useful to families. This online Multifamily Guided Self-Help version of FBT consists of 12 weekly 60-minute telemedicine groups made up of parents from 4-5 families of young people with AN, coupled with access to an online guided self-help platform over the course of 6 months. The feasibility of online Guided Self-Help Family-Based Treatment for Anorexia is unknown, and the investigators hope to identify an adequate treatment for those who do not have access to in-person FBT.
Detailed Description
Previous research has shown that Family-Based Treatment (FBT) is an effective treatment for Anorexia Nervosa. In the first Phase of FBT, parents are encouraged to take charge of the process of renourishing their child with Anorexia. Then, once the young person with Anorexia becomes better nourished and is managing to eat in a more sustainable way, the treatment moves to Phase 2. In Phase 2 of FBT, the focus is on helping parents to step back and support their child to regain their independence around eating. Once this happens, the treatment moves to Phase 3, where the family begins to move forward with their lives in a normal way, no longer focused on the eating disorder. The investigators hope to learn whether an adaptation of FBT, called online Multi-Family Guided Self-Help FBT, is feasible and acceptable for families of young people with Anorexia. The 'Self-Help' aspect of the treatment consists of a series of educational videos about how to help a child with Anorexia, which parents watch on an online platform. The 'Multifamily' and 'Guided' aspects of the treatment consists of weekly meetings by Zoom for a group of parents of young people with Anorexia, with a facilitator present to guide a group discussion around whether parents feel they understood the content of the videos and whether the content is helpful.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifamily Guided Self-Help Family-Based Treatment (MF-GSH-FBT)
Arm Type
Experimental
Arm Description
Treatment consists of up to 12 once-weekly online group sessions, where groups are made up of parents from 4-5 different families of young people with Anorexia. Group sessions will last approximately 50-60 minutes. Prior to each group session, parents watch recorded videos about how parents can help their child with Anorexia. Only parents, and not the young person with Anorexia, attend the group sessions.
Intervention Type
Behavioral
Intervention Name(s)
Multi-Family Guided Self-Help FBT
Intervention Description
Previous research has shown that Family-Based Treatment (FBT) is an effective treatment for Anorexia. We hope to learn whether an adaptation of Family-Based Treatment (FBT), called online Multi-Family Guided Self-Help FBT, is feasible and acceptable for families of young people with Anorexia. The 'Self-Help' aspect of the treatment consists of a series of educational videos for parents about how to help their child with Anorexia, which parents watch on an online platform. The 'Multifamily' and 'Guided' aspects of the treatment consists of weekly meetings by Zoom for a group of parents of young people with Anorexia, with a facilitator present to guide a group discussion around whether parents feel they understood the content of the videos and whether the content is helpful.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Number of participants enrolled in the study per month.
Time Frame
Assessed through the end of recruitment (about one year)
Title
Number of Treatment Sessions Attended
Time Frame
Through end of treatment (up to approximately 4 months)
Title
Treatment Retention Rate
Description
The count of participants who did not stop treatment before finishing the 12-session parent groups
Time Frame
Through end of treatment (up to approximately 4 months)
Title
Treatment Acceptability as Measured by Helping Alliance Questionnaire
Description
The Helping Alliance Questionnaire (HAQ) is an 11-item questionnaire that measures the quality of the therapist-patient relationship and will be completed by parents.
Time Frame
Through end of treatment (up to approximately 4 months)
Title
Treatment Acceptability as Measured by Therapy Suitability and Patient Expectancy questionnaire
Description
The Therapy Suitability and Patient Expectancy (TSPE) measures perceptions of the suitability and expectancy of the treatment provided and will be rated by parents.
Time Frame
Through end of treatment (up to approximately 4 months)
Secondary Outcome Measure Information:
Title
Eating Disorder Cognitions
Description
Eating Disorder Examination (EDE): This is a standardized measure that measures the severity of the characteristic psychopathology of eating disorders. It is to be administered by assessor to the adolescent with Anorexia at baseline and EOT.
Time Frame
Baseline and EOT (up to approximately 4 months)
Title
Expected Body Weight
Description
Expected Body Weight (EBW) percentages for the adolescent with Anorexia will be calculated using Center for Disease Control metrics in children and adolescents.
Time Frame
Baseline and EOT (up to approximately 4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescent participants are 12-17 years of age Adolescent participants live with a family (some families may contain only one parent) Family members fluently speak and read English and have access to a computer with internet Adolescent participants meet DSM-5 criteria for AN Adolescent participants' IBW above 75% Adolescent participants are 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 in any form that necessitates hospitalization of the adolescent with Anorexia Psychotic illness in any form, mental retardation, autism, or any other mental illness in the adolescent or parents/ carers that would interfere with the use of psychotherapy. Current dependence on drugs or alcohol in adolescent or parents. Physical conditions (e.g. diabetes mellitus, pregnancy) in adolescent known to influence eating or weight Participants and family members do not have an adequate understanding of spoken English and are not able to speak and read English in order to participate in family therapy and the assessments. Current weight is less than 75% of expected weight given age and height.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aileen Whyte, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Multifamily Guided Self-Help Family-Based Treatment (MF-GSH-FBT)

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