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

Anorexia Nervosa Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05446038
• Other study ID #: 62251
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: July 20, 2023

Study information

• Verified date: October 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 20, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• Multi-Family Guided Self-Help FBT
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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Number of participants enrolled in the study per month.	Assessed through the end of recruitment (about one year)
Primary	Number of Treatment Sessions Attended		Through end of treatment (up to approximately 4 months)
Primary	Treatment Retention Rate	The count of participants who did not stop treatment before finishing the 12-session parent groups	Through end of treatment (up to approximately 4 months)
Primary	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.	Through end of treatment (up to approximately 4 months)
Primary	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.	Through end of treatment (up to approximately 4 months)
Secondary	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.	Baseline and EOT (up to approximately 4 months)
Secondary	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.	Baseline and EOT (up to approximately 4 months)