Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203418
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-07-18
Brief Title:
Investigation of Multi-Family Therapy for Anorexia Nervosa
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Investigation of Multi-Family Therapy for Anorexia Nervosa
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed project is an intensive multi family therapy MFT intervention involving patients with anorexia nervosa and their families MFT interventions are informed from the principles of the family based treatment FBTfamily therapy for Anorexia Nervosa FT-AN models This program will offer families in vivovirtual support while connecting with other families to increase knowledge of eating disorders and develop skills related to successfully supporting their adolescent during difficult times including meal support and affect regulation Our objective is to explore the influence of the MFT intervention on the primary outcome measures in eating disorder treatment including weight expressed emotion and eating disorder symptomatology
Detailed Description:
The proposed project is an intensive multi family therapy MFT intervention involving patients with anorexia nervosa and their families MFT interventions are informed from the principles of the family based treatment FBTfamily therapy for Anorexia Nervosa FT-AN models This program will offer families in vivovirtual support while connecting with other families to increase knowledge of eating disorders and develop skills related to successfully supporting their adolescent during difficult times including meal support and affect regulation Our objective is to explore the influence of the MFT intervention on the primary outcome measures in eating disorder treatment including weight expressed emotion and eating disorder symptomatology
Familiespatients will participate in an initial phone screen with the study coordinator to determine eligibility for the MFT When participants are deemed eligible they will then follow-up with a trained study assessor where they will be consented for the study and complete both written and interview based assessments Parents are welcome to participate without their child if their child does not wish to assent the child may assent and participate in further treatment days if they wish Families attending the group will continue to complete assessments throughout the study Parents will complete the assessment interviews to their best knowledge about their child if their child does not choose to participate Once a child agrees to participate they will complete assessment interviews themselves Patients will receive medical clearanceassessment by their primary care doctor or Eating Disorder medical provider prior to the start of the group All medical assessments will be reviewed by Dr Karen Bernstein When in person group gatherings may resume each treatment group will consist of 3-8 families with a new cohort starting approximately every 6 weeks total of 6-8 sessions over a 1 year time period
Accepted families will then by the 4 day MFT Day 1 will involve a two hour orientation to the group Families will learn the medical consequences of eating disorders psychological principles of the treatment intervention the expectations of participation meet the treatment team as well as hear from a family who has been through treatment On the rest of day 1 through day 4 families will participate in a variety of planned activities aimed at facilitating change throughout the treatment process Additionally the in person group will have 3 3-6 hour follow up group sessions scheduled at 2 weeks post intervention virtual 1 month post intervention in person and 3 months post intervention in person In the virtual model each treatment group will consist of 3-8 families with a new cohort starting approximately every 4-6 weeks total of 8 -13 sessions over a 1 year time period Day 1 will be a similar orientation as described above using the Zoom virtual platform On the rest of day 1 and through day 4 families will participate in synchronous and asynchronous activities modified for the virtual format Families in the virtual group will also participate in 3 3-hour follow up sessions in 2 weeks 1 month 3 months all virtual
Per the Multi-Family Therapy for Anorexia Nervosa Treatment Manual Draft Simic M Baudinet J et al mechanisms of change in the group involve
1 Multiple sources of input parents carers young people professionals working together will allow participants to be both givers and receivers of new ideasthoughts Additionally this will allow families to experiment with new behavioral interventions The group is aimed at offering young people and their families the opportunity to experience simultaneous different roles This process allows for new learning and experimentation with new ideas around the illness and family Meeting families that are confronted with the same illness yet at different stages of recovery makes experience sharing particularly rich and can inspire hope for change
2 The MFT is designed purposefully with increased intensity and broadening of the treatment scope Families receive a large dose of the treatment in the format of 4 6 hour days in person or 4 4 hour days with additional asynchronous tasks virtual The dose of treatment is created to match the intensity of the illness and promote behavioral experimentation and change within a short period of time This 4 day burst has the primary aim of increasing parental efficacy in taking charge of the patients illness Families will participate in additional follow up sessions to boost and monitor the effects of the intervention
3 The MFT is designed to increase solidarity reduce isolation and facilitate building a community around behavioral change
The overall themes of the intervention are engagement and understanding of the illness and its impact on the family managing mealtimes and providing in vivo support during meals and processproblem solving around mealtimes exploration of the impact of the illness of family relationships and working to set a path to improve them and planning for the future Simic M Baudinet J et al The intervention will include educationalcognitive behavioral motivational and problem-solving components along with relational elements
Familiespatients will participate in an initial phone screen with the study coordinator to determine eligibility for the MFT When participants are deemed eligible they will then follow-up with a trained study assessor where they will be consented for the study and complete both written and interview based assessments Parents are welcome to participate without their child if their child does not wish to assent the child may assent and participate in further treatment days if they wish Families attending the group will continue to complete assessments throughout the study Parents will complete the assessment interviews to their best knowledge about their child if their child does not choose to participate Once a child agrees to participate they will complete assessment interviews themselves Patients will receive medical clearanceassessment by their primary care doctor or Eating Disorder medical provider prior to the start of the group All medical assessments will be reviewed by Dr Karen Bernstein When in person group gatherings may resume each treatment group will consist of 3-8 families with a new cohort starting approximately every 6 weeks total of 6-8 sessions over a 1 year time period
Accepted families will then by the 4 day MFT Day 1 will involve a two hour orientation to the group Families will learn the medical consequences of eating disorders psychological principles of the treatment intervention the expectations of participation meet the treatment team as well as hear from a family who has been through treatment On the rest of day 1 through day 4 families will participate in a variety of planned activities aimed at facilitating change throughout the treatment process Additionally the in person group will have 3 3-6 hour follow up group sessions scheduled at 2 weeks post intervention virtual 1 month post intervention in person and 3 months post intervention in person In the virtual model each treatment group will consist of 3-8 families with a new cohort starting approximately every 4-6 weeks total of 8 -13 sessions over a 1 year time period Day 1 will be a similar orientation as described above using the Zoom virtual platform On the rest of day 1 and through day 4 families will participate in synchronous and asynchronous activities modified for the virtual format Families in the virtual group will also participate in 3 3-hour follow up sessions in 2 weeks 1 month 3 months all virtual
Per the Multi-Family Therapy for Anorexia Nervosa Treatment Manual Draft Simic M Baudinet J et al mechanisms of change in the group involve
1 Multiple sources of input parents carers young people professionals working together will allow participants to be both givers and receivers of new ideasthoughts Additionally this will allow families to experiment with new behavioral interventions The group is aimed at offering young people and their families the opportunity to experience simultaneous different roles This process allows for new learning and experimentation with new ideas around the illness and family Meeting families that are confronted with the same illness yet at different stages of recovery makes experience sharing particularly rich and can inspire hope for change
2 The MFT is designed purposefully with increased intensity and broadening of the treatment scope Families receive a large dose of the treatment in the format of 4 6 hour days in person or 4 4 hour days with additional asynchronous tasks virtual The dose of treatment is created to match the intensity of the illness and promote behavioral experimentation and change within a short period of time This 4 day burst has the primary aim of increasing parental efficacy in taking charge of the patients illness Families will participate in additional follow up sessions to boost and monitor the effects of the intervention
3 The MFT is designed to increase solidarity reduce isolation and facilitate building a community around behavioral change
The overall themes of the intervention are engagement and understanding of the illness and its impact on the family managing mealtimes and providing in vivo support during meals and processproblem solving around mealtimes exploration of the impact of the illness of family relationships and working to set a path to improve them and planning for the future Simic M Baudinet J et al The intervention will include educationalcognitive behavioral motivational and problem-solving components along with relational elements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None