Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID
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|ClinicalTrials.gov Identifier: NCT04450771|
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
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
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Kyra Citron, BA 650-723-9182 firstname.lastname@example.org|
|Contact: Ayotola Onipede, BA 650-723-7885 email@example.com|
|Principal Investigator: James D Lock, MD, PhD|
|Sub-Investigator: Cara Bohon, PhD|