Anorexia NervosaMF-GSH-FBTNCT05446038
Multifamily Guided Self-Help Family-Based Treatment (MF-GSH-FBT)
A study testing Multi-Family Guided Self-Help FBT in people with Anorexia Nervosa, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Multi-Family Guided Self-Help FBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Multi-Family Guided Self-Help FBT
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Family Guided Self-Help FBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multi-Family Guided Self-Help FBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants enrolled in the study per month.
Measured: Assessed through the end of recruitment (about one year)
Number of Treatment Sessions Attended
Measured: 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
Measured: 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.
Measured: 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.
Measured: Through end of treatment (up to approximately 4 months)
Secondary outcomes (2)
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.
Measured: Baseline and EOT (up to approximately 4 months)
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.
Measured: Baseline and EOT (up to approximately 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Mar 2022
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aileen Whyte, Stanford University
- Investigators
- Aileen Whyte, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446038
- Sponsor's protocol ID
- 62251
- Acronym
- MF-GSH-FBT
- Status last verified
- Oct 2023
- First submitted
- 21 Jun 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05446038
- Acronym / sponsor ID
- MF-GSH-FBT / 62251
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multifamily Guided Self-Help Family-Based Treatment (MF-GSH-FBT) | Experimental | Behavioral: Multi-Family Guided Self-Help FBTTreatment 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Family Guided Self-Help FBTPrevious 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. | Behavioural | Multifamily Guided Self-Help Family-Based Treatment (MF-GSH-FBT) |
Primary outcome
Recruitment Rate
Time frame: Assessed through the end of recruitment (about one year)
Number of participants enrolled in the study per month.
Number of Treatment Sessions Attended
Time frame: Through end of treatment (up to approximately 4 months)
Treatment Retention Rate
Time frame: Through end of treatment (up to approximately 4 months)
The count of participants who did not stop treatment before finishing the 12-session parent groups
Treatment Acceptability as Measured by Helping Alliance Questionnaire
Time frame: Through end of treatment (up to approximately 4 months)
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
Time frame: Through end of treatment (up to approximately 4 months)
The Therapy Suitability and Patient Expectancy (TSPE) measures perceptions of the suitability and expectancy of the treatment provided and will be rated by parents.
2 secondary outcomes
Eating Disorder Cognitions
Time frame: Baseline and EOT (up to approximately 4 months)
Expected Body Weight
Time frame: Baseline and EOT (up to approximately 4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aileen Whyte, Ph.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Family Guided Self-Help FBT in people with Anorexia Nervosa, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Assessed through the end of recruitment (about one year)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.