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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
98
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.
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 5 parent-only meetings, all of which are 1-hour over a 4 month period.
Stanford University
Stanford, California, United States
Expected Body Weight (EBW)
Expected Body Weights (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents.
Time frame: Following 4 months of FBT-ARFID or NSC
Parents versus Avoidant/Restrictive Food Intake Disorder (ARFID)
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.
Time frame: Following 4 months of FBT-ARFID or NSC
Parental Feeding Behavior Assessment
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.
Time frame: After week 6 of either arm in all participants.
The Pica, ARFID, Rumination Disorder Interview (PARDI)
The PARDI is a new measure designed to diagnose and evaluate symptom severity of ARFID putative subtypes. Data demonstrate the measure's validity and ability to distinguish ARFID patients from other clinical groups. Parents will be assessed using the PARDI.
Time frame: All assessment time points (BL, 1 month, 2 months, EOT, and 6-month follow-up)
Therapy Suitability and Patient Expectancy (TSPE)
The TSPE measures perceptions of the suitability and expectancy of the treatment provided and will be rated by parents
Time frame: At the end of session 1 and every two weeks during treatment and NSC.
Parenting Style Questionnaire (PSQ)
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This questionnaire is a validated measure of parenting style related to authoritative and permissive style. This questionnaire will be completed parents.
Time frame: Completed at baseline and EOT
Center for Epidemiological Studies Depression Scale for Children (CES-DC)
This is a validated measure of child depression that will be completed by children.
Time frame: Completed by children at all major assessment timepoints.
Revised Children's Manifest Anxiety Scale (RCMAS-2)
This is a validated measure of childhood anxiety and will be completed by children.
Time frame: Completed by children at all major assessment timepoints.
Helping Relationship Questionnaire (HRQ)
The HRQ is an 11-item questionnaire that measures the quality of the therapist-patient relationship. The HRQ will be completed by parents.
Time frame: Completed by parents bi-weekly and at all major assessment points except baseline.
Schedule for Affective Disorders and Schizophrenia for School-Aged Children (6-18 years) (K-SADS)
The K-SADS-PL is a widely used semi-structured interview detecting psychiatric disorders in children and adolescents.
Time frame: Completed by parents on behalf of their child at baseline.
Strengths and Difficulties Questionnaire (SDQ)
The 25 items in the SDQ assess conduct, social, and peer behaviors.
Time frame: Completed by parents at all major assessment points.
Beck Depression Inventory (BDI)
The BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. This measure also includes questions about suicidal ideation and intent.
Time frame: Completed by parents at BL and EOT.
Beck Anxiety Inventory (BAI)
A 21-item questionnaire about anxiety.
Time frame: Completed by parents at BL and EOT.
36-Item Short Form (SF-36)
A general measure of physical and mental health functioning. This assessment will be taken by the parents.
Time frame: Completed by parents at BL.
Bandura's General Self-Efficacy Scale (GSES)
Measure of parental self-efficacy.
Time frame: Completed by parents at all major assessments as well as after each of the 14 treatment sessions.
Parental Sense of Competency Scale (PSOC)
Measure of parental self-efficacy.
Time frame: Completed by parents at all major assessments as well as after each of the 14 treatment sessions.