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Completed

NCT Number: NCT04450771

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family-based Treatment for ARFID

Behavioral

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 names: FBT-ARFID

Manualized Non-Specific Usual Care for ARFID

Behavioral

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.

Other names: NSC

Primary outcomes

  1. Expected Body Weight (EBW)

    Time frame: Following 4 months of FBT-ARFID or NSC

    Expected Body Weights (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents.

  2. 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.

  3. Parental Feeding Behavior Assessment

    Time frame: After 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.

Secondary outcomes

  1. The Pica, ARFID, Rumination Disorder Interview (PARDI)

    Time frame: All assessment time points (BL, 1 month, 2 months, EOT, and 6-month follow-up)

    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.

  2. Therapy Suitability and Patient Expectancy (TSPE)

    Time frame: At the end of session 1 and every two weeks during treatment and NSC.

    The TSPE measures perceptions of the suitability and expectancy of the treatment provided and will be rated by parents

  3. Parenting Style Questionnaire (PSQ)

    Time frame: Completed at baseline and EOT

    This questionnaire is a validated measure of parenting style related to authoritative and permissive style. This questionnaire will be completed parents.

  4. Center for Epidemiological Studies Depression Scale for Children (CES-DC)

    Time frame: Completed by children at all major assessment timepoints.

    This is a validated measure of child depression that will be completed by children.

  5. Revised Children's Manifest Anxiety Scale (RCMAS-2)

    Time frame: Completed by children at all major assessment timepoints.

    This is a validated measure of childhood anxiety and will be completed by children.

  6. Helping Relationship Questionnaire (HRQ)

    Time frame: Completed by parents bi-weekly and at all major assessment points except baseline.

    The HRQ is an 11-item questionnaire that measures the quality of the therapist-patient relationship. The HRQ will be completed by parents.

  7. Schedule for Affective Disorders and Schizophrenia for School-Aged Children (6-18 years) (K-SADS)

    Time frame: Completed by parents on behalf of their child at baseline.

    The K-SADS-PL is a widely used semi-structured interview detecting psychiatric disorders in children and adolescents.

  8. Strengths and Difficulties Questionnaire (SDQ)

    Time frame: Completed by parents at all major assessment points.

    The 25 items in the SDQ assess conduct, social, and peer behaviors.

  9. Beck Depression Inventory (BDI)

    Time frame: Completed by parents at BL and EOT.

    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.

  10. Beck Anxiety Inventory (BAI)

    Time frame: Completed by parents at BL and EOT.

    A 21-item questionnaire about anxiety.

  11. 36-Item Short Form (SF-36)

    Time frame: Completed by parents at BL.

    A general measure of physical and mental health functioning. This assessment will be taken by the parents.

  12. Bandura's General Self-Efficacy Scale (GSES)

    Time frame: Completed by parents at all major assessments as well as after each of the 14 treatment sessions.

    Measure of parental self-efficacy.

  13. Parental Sense of Competency Scale (PSOC)

    Time frame: Completed by parents at all major assessments as well as after each of the 14 treatment sessions.

    Measure of parental self-efficacy.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Confirming the Efficacy/Mechanism of Family Therapy for Children With Low Weight Avoidant/Restrictive Food Intake Disorder (ARFID)

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jun 30, 2020
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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