Bulimia NervosaABFTNCT04779801
Attachment-Based Family Therapy for Adolescents With Binge Eating
A study testing Attachment-Based Family Therapy in people with Bulimia Nervosa and Binge-Eating Disorder, run by Drexel University at 1 site in United States.
Trial summary
The purpose of this study is to examine whether Attachment-Based Family Therapy (ABFT), a well-validated treatment for adolescents with depression and suicidality, is feasible and acceptable for adolescents with binge eating and their families. Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Bulimia Nervosa, Binge-Eating Disorder, Other Specified Feeding or Eating Disorder
- What is being tested?
- Attachment-Based Family Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2020to 10 Apr 2022
- 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 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Speak, write, and understand English
- Age 12-22 years old
- Have a diagnosis of DSM-5 AN, BN, BED, or OSFED
- Medically stable for outpatient treatment
- Must have a parent, guardian, or primary caregiver who is willing to participate in the study and treatment
Who cannot join
- Acute suicide risk
- No parent or guardian agreement to participate
- Are currently receiving psychological treatment for an eating disorder
- Are currently receiving weight loss treatment
- Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)
- Diagnosis of intellectual disability
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
Sophie R Abber, B.A., 215-553-7110, wellteen@drexel.edu
Stephanie M Manasse, Ph.D.
About this study
Official title: Attachment-Based Family Therapy for Adolescents With Transdiagnostic Binge Eating
The purpose of this study is to examine whether Attachment-Based Family Therapy (ABFT), a well-validated treatment for adolescents with depression and suicidality, is feasible and acceptable for adolescents with binge eating and their families.
Read the detailed description
This study involves a phone screen and baseline assessment to determine eligibility. Participants who are eligible for the study will receive 16 weeks of ABFT treatment. The treatment primarily focuses on improving communication and relationships within the family, and will also address disordered eating behaviors (e.g., binge eating, laxative use, self-induced vomiting). All participants enrolled in the study will receive the same treatment. Participants will also complete research assessments throughout treatment, at the end of treatment, and 3-months after the end of treatment. Research assessments include a battery of questionnaires and interviews.
- Being tested
- Attachment-Based Family Therapy
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment-Based Family TherapyBehavioural
16 weeks of Attachment-Based Family Therapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| ABFT | Experimental | Adolescents and one or both parents will complete 16 weeks of Attachment-Based Family Therapy treatment. Receives: Behavioral: Attachment-Based Family Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-Minute Speech Sample (FMSS)
The Five-Minute Speech Sample is a widely-used interview to assess critical comments and emotional overinvolvement in families.
Measured: Change in critical comments and emotional overinvolvement from baseline to treatment completion, at 16 weeks
Secondary outcomes (1)
Eating Disorder Examination (EDE)
The Eating Disorder Examination is a widely-used, semi-structured interview for the assessment of eating disorder symptoms.
Measured: Change in frequency of binge-eating and, if applicable, purging from baseline to treatment completion, at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start10 Dec 2020
- Primary completion10 Dec 2021 (estimated)
- Study completion10 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779801
- Sponsor's protocol ID
- 2004007768
- Acronym
- ABFT
- Status last verified
- Dec 2020
- First submitted
- 25 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attachment-Based Family Therapy for Adolescents With Transdiagnostic Binge Eating
- ClinicalTrials.gov ID
- NCT04779801
- Acronym / sponsor ID
- ABFT / 2004007768
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 10 Dec 2021 (estimated)
- Study completion
- 10 Apr 2022 (estimated)
- First posted
- 3 Mar 2021 (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.
The purpose of this study is to examine whether Attachment-Based Family Therapy (ABFT), a well-validated treatment for adolescents with depression and suicidality, is feasible and acceptable for adolescents with binge eating and their families.
Detailed description
This study involves a phone screen and baseline assessment to determine eligibility. Participants who are eligible for the study will receive 16 weeks of ABFT treatment. The treatment primarily focuses on improving communication and relationships within the family, and will also address disordered eating behaviors (e.g., binge eating, laxative use, self-induced vomiting). All participants enrolled in the study will receive the same treatment. Participants will also complete research assessments throughout treatment, at the end of treatment, and 3-months after the end of treatment. Research assessments include a battery of questionnaires and interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABFT | Experimental | Behavioral: Attachment-Based Family TherapyAdolescents and one or both parents will complete 16 weeks of Attachment-Based Family Therapy treatment. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Speak, write, and understand English
- Age 12-22 years old
- Have a diagnosis of DSM-5 AN, BN, BED, or OSFED
- Medically stable for outpatient treatment
- Must have a parent, guardian, or primary caregiver who is willing to participate in the study and treatment
Key exclusion criteria (6 listed)
- Acute suicide risk
- No parent or guardian agreement to participate
- Are currently receiving psychological treatment for an eating disorder
- Are currently receiving weight loss treatment
- Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)
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 |
|---|---|---|
| Attachment-Based Family Therapy16 weeks of Attachment-Based Family Therapy treatment. | Behavioural | ABFT |
Primary outcome
Five-Minute Speech Sample (FMSS)
Time frame: Change in critical comments and emotional overinvolvement from baseline to treatment completion, at 16 weeks
The Five-Minute Speech Sample is a widely-used interview to assess critical comments and emotional overinvolvement in families.
1 secondary outcome
Eating Disorder Examination (EDE)
Time frame: Change in frequency of binge-eating and, if applicable, purging from baseline to treatment completion, at 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attachment-Based Family Therapy in people with Bulimia Nervosa and Binge-Eating Disorder, run by Drexel 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 5 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: status not confirmed, as of the sponsor's last update on 3 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-Minute Speech Sample (FMSS) (time frame: Change in critical comments and emotional overinvolvement from baseline to treatment completion, at 16 weeks). 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 3 Mar 2021.