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

Primary Purpose

Avoidant/Restrictive Food Intake Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Family-based Treatment for ARFID

Manualized Non-Specific Usual Care for ARFID

About this trial

This is an interventional treatment trial for Avoidant/Restrictive Food Intake Disorder focused on measuring FBT, Family Based Treatment, ARFID

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family-based Treatment for ARFID(FBT-ARFID)

Manualized Non-Specific Usual Care for ARFID(NSC)

Arm Description

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.

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 5 parent-only meetings. Sessions are 1-hour. NSC matches FBT-ARFID for time and therapist attention. The focus of the NSC 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.

Outcomes

Primary Outcome Measures

Expected Body Weight (EBW)

Expected 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)

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

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 Outcome Measures

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.

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

Parenting Style Questionnaire (PSQ)

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

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

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

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

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

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.

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.

Strengths and Difficulties Questionnaire (SDQ)

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

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.

Beck Anxiety Inventory (BAI)

A 21-item questionnaire about anxiety.

36-Item Short Form (SF-36)

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

Bandura's General Self-Efficacy Scale (GSES)

Measure of parental self-efficacy.

Parental Sense of Competency Scale (PSOC)

Measure of parental self-efficacy.

Full Information

NCT ID

NCT04450771

First Posted

June 22, 2020

Last Updated

January 16, 2023

Sponsor

Stanford University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04450771

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Avoidant/Restrictive Food Intake Disorder

Keywords

FBT, Family Based Treatment, ARFID

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Family-based Treatment for ARFID(FBT-ARFID)

Arm Type

Experimental

Arm Description

Arm Title

Manualized Non-Specific Usual Care for ARFID(NSC)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Family-based Treatment for ARFID

Other Intervention Name(s)

FBT-ARFID

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Manualized Non-Specific Usual Care for ARFID

Other Intervention Name(s)

NSC

Intervention Description

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.

Primary Outcome Measure Information:

Title

Expected Body Weight (EBW)

Description

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

Title

Parents versus Avoidant/Restrictive Food Intake Disorder (ARFID)

Description

Time Frame

Following 4 months of FBT-ARFID or NSC

Title

Parental Feeding Behavior Assessment

Description

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.

Secondary Outcome Measure Information:

Title

The Pica, ARFID, Rumination Disorder Interview (PARDI)

Description

Time Frame

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

Title

Therapy Suitability and Patient Expectancy (TSPE)

Description

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.

Title

Parenting Style Questionnaire (PSQ)

Description

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

Title

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

Description

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

Time Frame

Completed by children at all major assessment timepoints.

Title

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

Description

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

Time Frame

Completed by children at all major assessment timepoints.

Title

Helping Relationship Questionnaire (HRQ)

Description

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.

Title

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

Description

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.

Title

Strengths and Difficulties Questionnaire (SDQ)

Description

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

Time Frame

Completed by parents at all major assessment points.

Title

Beck Depression Inventory (BDI)

Description

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.

Title

Beck Anxiety Inventory (BAI)

Description

A 21-item questionnaire about anxiety.

Time Frame

Completed by parents at BL and EOT.

Title

36-Item Short Form (SF-36)

Description

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

Time Frame

Completed by parents at BL.

Title

Bandura's General Self-Efficacy Scale (GSES)

Description

Measure of parental self-efficacy.

Time Frame

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

Title

Parental Sense of Competency Scale (PSOC)

Description

Measure of parental self-efficacy.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eliza M Van Wye, B.A.

Phone

(650) 723-5521

evanwye@stanford.edu

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kyra Citron, BA

Phone

650-723-9182

kcitron@stanford.edu

First Name & Middle Initial & Last Name & Degree

Ayotola Onipede, BA

Phone

650-723-7885

zonipede@stanford.edu

First Name & Middle Initial & Last Name & Degree

James D Lock, MD, PhD

First Name & Middle Initial & Last Name & Degree

Cara Bohon, PhD

12. IPD Sharing Statement

Plan to Share IPD

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

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