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Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450771
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
James Dale Lock, Stanford University

Brief Summary:
This study is examining the efficacy and mechanism of family therapy compared to usual care for children between the ages of 6 and 12 who are diagnosed with Avoidant restrictive food intake disorder. Preliminary data suggest that family therapy is superior to usual care and that improvement in parental self-efficacy related to feeding their children is the mechanism of treatment. In addition, this study will attempt to identify specific patient groups who respond to family therapy.

Condition or disease Intervention/treatment Phase
Avoidant/Restrictive Food Intake Disorder Behavioral: Family-based Treatment for ARFID Behavioral: Manualized Non-Specific Usual Care for ARFID Not Applicable

Detailed Description:

Potential subjects aged 6 years to 12 years, 11 months old with DSM 5 ARFID, and weight below 88% EBW who are medically stable for outpatient treatment and their families will be recruited through Stanford University, pediatricians, mental health experts, clinics treating EDs, and local parents' groups. Those eligible for the program will be invited to read and sign informed consent forms and complete the baseline assessment. Participants will then be randomized to FBT-ARFID with medical management for 14 sessions provided over 4 months or manualized Non-Specific Care (NSC) with medical management for 4 months. NSC will consist of 14 sessions over 4 months.

There will be 5 major assessment time points: Baseline, 1 month, 2 months, End Of Treatment, and 6-month post-treatment Follow-Up. Both the child and the parent will complete measures at these time points. In addition, patients and parents will participate in short bi-weekly survey assessments for the first 2 months of treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight Avoidant/Restrictive Food Intake Disorder (ARFID)
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Family-based Treatment for ARFID(FBT-ARFID)
FBT-ARFID is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior. Early sessions focus on inciting parents to make changes and include a family meal that allows therapists to observe & consult directly to mealtime behaviors. FBT-ARFID for children 12 and under is manualized and consists of 2 phases. The first phase is focused on parents taking charge & changing the eating behaviors of their child that are maintaining ARFID. The second phase focuses on the child taking up in an age-appropriate way managing their eating consistent with the changes the parents have employed in phase 1. Fourteen 1-hour sessions will be conducted approximately weekly over 4 months. Throughout medical monitoring and weekly dietary consultation are available to the family.
Behavioral: Family-based Treatment for ARFID
This treatment includes 14 1-hour sessions that will be conducted approximately weekly over a 4 month period. It is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior.
Other Name: FBT-ARFID

Active Comparator: Manualized Non-Specific Usual Care for ARFID(NSC)
A manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model that has been used in other RCTs with eating disorders as a comparison. NSC consists of sessions with the child alone and 7 parent only meetings. Sessions are 1-hour. NSC matches FBT-ARFID for time and therapist attention. The focus of the NSP intervention is psychoeducation about health & social impacts of restrictive eating and supporting parent & child exploration of motivation to change eating patterns & choices they make about changes to eating. The therapist does not initiate behavioral or cognitive interventions. Feelings about eating and making changes are explored in both the child and parent sessions. Medical and dietary advice are provided weekly.
Behavioral: Manualized Non-Specific Usual Care for ARFID
This treatment is a manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model. It consists of sessions with the child alone and 7 parent only meetings, all of which are 1-hour over a 4 month period.
Other Name: NSC




Primary Outcome Measures :
  1. Estimated Body Weight (EBW) [ Time Frame: Following 4 months of FBT-ARFID or NSC ]
    Estimated Body Weights (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents.


Secondary Outcome Measures :
  1. Parents versus Avoidant/Restrictive Food Intake Disorder (ARFID) [ Time Frame: Following 4 months of FBT-ARFID or NSC ]
    A modification of the Parents versus Anorexia Nervosa Scale, a measure of parental self-efficacy at changing eating behaviors. The modifications to the scale are minor and consisted of changing the name of the disorder named in the scale's questions from AN to ARFID. This is a 7 item 5 point scale where higher scores mean greater parental self-efficacy.

  2. Parental Feeding Behavior Assessment [ Time Frame: Afrer week 6 of either arm in all participants. ]
    Meals at Baseline and Week 6 will be recorded and then coded for behaviors associated with successful re-feeding using a procedure developed for FBT.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children meeting DSM-V criteria for ARFID
  • Children between the ages of 6 to 12 years old
  • Medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine.
  • Not engaging in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study.
  • No prior FBT
  • If taking medication for co-morbid disorders, participants must be on a stable dose of medication for 8 weeks (2 months) before participating. If the participant is on a new medication at baseline, but is discontinuing the medication in order to start the study, they must have discontinued the medication before beginning treatment.
  • IBW between 75% and 88%.
  • Able to fluently speak and read English

Exclusion Criteria:

  • Current psychotic illness or mental retardation or other mental illnesses that would prohibit the use of psychotherapy
  • Current dependence on drugs or alcohol
  • Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • Any medical complications or severe mental disorder (psychosis, low-functioning Autism) that may reduce compliance with the study procedures or require more intensive care to manage the symptoms
  • Previous FBT
  • Currently taking medication for co-morbid disorders that cannot be safely discontinued or prescribed for less than 2 months
  • In the case of patients with current, or a history of sexual or physical abuse by family members, perpetrators of the abuse will be excluded from treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450771


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Contact: Kyra Citron, BA    650-723-9182    kcitron@stanford.edu   
Contact: Ayotola Onipede, BA    650-723-7885    zonipede@stanford.edu   
Principal Investigator: James D Lock, MD, PhD         
Sub-Investigator: Cara Bohon, PhD         
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
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Responsible Party: James Dale Lock, Professor of Child Psychiatry and Pediatrics in the Department of Psychiatry and Behavioral Sciences and Director of the Eating Disorder Program for Children and Adolescents, Stanford University
ClinicalTrials.gov Identifier: NCT04450771    
Other Study ID Numbers: 56878
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Dale Lock, Stanford University:
FBT
Family Based Treatment
ARFID