Clinical trial NCT04450771: Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight ARFID
Official title: Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight Avoidant/Restrictive Food Intake Disorder (ARFID)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Avoidant/Restrictive Food Intake Disorder
Keywords: FBT
Family Based Treatment
ARFID
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2020-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Potential subjects aged 6 years to 12 years, 11 months old with DSM 5 ARFID, and weight equal to or between 75 to 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 (4 months), and 6-month post-treatment Follow-Up. Both the child and the parent will complete measures at these time points. In addition, parents will complete short survey assessments after each of the 14 treatment sessions.

Eligibility criteria: Inclusion Criteria:

* Children meeting DSM-V criteria for ARFID
* Children between the ages of 6 to 12 years old, living with their families
* 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.
* Less than 4 sessions of 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.
* EBW between 75% and 88%.
* Able to fluently speak and read English

Exclusion Criteria:

* Current physical, psychotic illness or other mental illness requiring hospitalization
* 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
* 4 or more sessions of FBT
* Currently taking medication for co-morbid disorders that cannot be safely discontinued or prescribed for less than 2 months
* Medically unstable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine, defined as: vital sign instability (heart rate less than 45 beats per minute), clinically significant orthostatic blood pressure with changes usually greater than 35 points or findings of gastrointestinal bleeding, dizziness, or syncope, IBW \<75%, hypothermia (body temperature less than 36 degrees centigrade), clinically significant electrolyte abnormalities, or prolonged QTc on electrocardiogram
* Expected Body Weight (EBW) \<75% or \> 88%
* Unable to fluently speak and read English
* Parent excluded
* Suicidal
* 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.

Primary outcomes:
measure: Expected Body Weight (EBW)
timeFrame: Following 4 months of FBT-ARFID or NSC
measure: Parents versus Avoidant/Restrictive Food Intake Disorder (ARFID)
timeFrame: Following 4 months of FBT-ARFID or NSC
measure: Parental Feeding Behavior Assessment
timeFrame: After week 6 of either arm in all participants.
Secondary outcomes:
measure: The Pica, ARFID, Rumination Disorder Interview (PARDI)
timeFrame: All assessment time points (BL, 1 month, 2 months, EOT, and 6-month follow-up)
measure: Therapy Suitability and Patient Expectancy (TSPE)
timeFrame: At the end of session 1 and every two weeks during treatment and NSC.
measure: Parenting Style Questionnaire (PSQ)
timeFrame: Completed at baseline and EOT
measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC)
timeFrame: Completed by children at all major assessment timepoints.
measure: Revised Children's Manifest Anxiety Scale (RCMAS-2)
timeFrame: Completed by children at all major assessment timepoints.
measure: Helping Relationship Questionnaire (HRQ)
timeFrame: Completed by parents bi-weekly and at all major assessment points except baseline.
measure: Schedule for Affective Disorders and Schizophrenia for School-Aged Children (6-18 years) (K-SADS)
timeFrame: Completed by parents on behalf of their child at baseline.
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Completed by parents at all major assessment points.
measure: Beck Depression Inventory (BDI)
timeFrame: Completed by parents at BL and EOT.
measure: Beck Anxiety Inventory (BAI)
timeFrame: Completed by parents at BL and EOT.
measure: 36-Item Short Form (SF-36)
timeFrame: Completed by parents at BL.
measure: Bandura's General Self-Efficacy Scale (GSES)
timeFrame: Completed by parents at all major assessments as well as after each of the 14 treatment sessions.
measure: Parental Sense of Competency Scale (PSOC)
timeFrame: Completed by parents at all major assessments as well as after each of the 14 treatment sessions.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References: