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

NCT05446038 | Completed

• 1 other identifier: 62251
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  Number of participants enrolled in the study per month.

  Assessed through the end of recruitment (about one year)

• Number of Treatment Sessions Attended

  Through end of treatment (up to approximately 4 months)

• 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)

• 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)

• 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 Outcomes (2)

• Eating Disorder Cognitions

  Baseline and EOT (up to approximately 4 months)

• Expected Body Weight

  Baseline and EOT (up to approximately 4 months)

Study Arms (1)

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

EXPERIMENTAL

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.

Behavioral: Multi-Family Guided Self-Help FBT

Interventions

Multi-Family Guided Self-Help FBT BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Aileen Whyte, Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Psychiatry and Behavioral Sciences - Child & Adolescent Psychiatry and Child Development

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 6, 2022
• Study Start: March 1, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)