NCT07566546

Brief Summary

The goal of this clinical trial is to learn if a brief parent educational video series is feasible, acceptable, and effective for improving parent and patient outcomes for adolescents with Anorexia Nervosa. The main questions it aims to answer are: Do parents want to watch these educational videos and find them helpful/useful ? Do parents who watch the videos report improvement in their knowledge about restrictive eating disorders and self-efficacy in helping their child recover, as well as reductions in stress and burden associated with parenting a child with anorexia? Do adolescents (ages 10-16) report improvements in their eating disorder symptoms when their parents watch these videos? Investigators will compare treatment as usual (traditional family and individual therapy with regular medical and nutrition visits) to treatment as usual plus the parent educational videos to see if the videos improve parental and patient outcomes beyond treatment as usual. Parent and adolescent participants will complete baseline measures including: Parent measures: eating disorder knowledge, self-efficacy, stress and burnout Patient (adolescent) measures: eating disorder symptoms, depression symptoms, anxiety symptoms Parents will complete these measures immediately after first meeting with their child's medical doctor to confirm a diagnosis of a restrictive eating disorder and then again 3 months later. The investigators will also assess the video feasibility and acceptability by asking parents to report their satisfaction with the videos and to assess how many approached families enroll in the study.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Mar 2027

Study Start

First participant enrolled

April 14, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 21, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Anorexia NervosaAtypical Anorexia NervosaParent interventionOnline intervention

Outcome Measures

Primary Outcomes (2)

  • Feasibility: The investigators will measure feasibility by determining how many parent-adolescent dyads that meet eligibility criteria actually enroll in the study.

    Is the PEV intervention feasible? Do at least 70% of families eligible for enrollment, agree to enroll in the study and watch the videos.

    1 year for recruitment

  • Acceptability: 13 self-report questions assessing satisfaction and value in the parent educational videos using a 1-5 rating where 1 = very unsatisfied and 5 = very satisfied.

    Acceptability: The investigators will measure acceptability by the following parental self-report questions: 1. I liked the parent education videos. 2. The videos kept my attention. 3. It was/would be easy to find time to watch the videos. 4. The videos helped me feel more confident in how to help my child recover. 5. The videos provided useful parenting strategies. 6. I felt comfortable with the approach used in the videos. 7. The purpose of the videos was clear to me. 8. The value of the content of these videos was worth my time. 9. I feel capable of applying what I learned from the videos. 10. Overall, I am satisfied with the parent education videos. 11. I would recommend these videos to other parents. 12. I was satisfied with the length of the videos 13. I was satisfied with the audio and visual content of the videos Higher scores = greater satisfaction, a total score will include the mean of all 13 items such that the mean score range is 1 to 5.

    within 30 days of enrollment in the study

Secondary Outcomes (6)

  • Improvement in Parental Self-efficacy (Brief Parental Self-Efficacy Scale; Woolgar et al., 2025; total score ranges from a minimum of 5 to a maximum of 25)

    3 months from enrollment in the study

  • Improvement in Parental Stress and Burnout (The Parental Burnout Assessment, Roskam et al., 2018; minimum total score of 0 and a maximum total score of 138)

    3 months post enrollment

  • Improvement in Parental Knowledge about Eating Disorders (Parent Anorexia Knowledge Questionnaire, developed by the investigators from previous measures (Bryson et al.,2018 and Girz et al. 2014); Min-Max score is 0-15 where 15 = greater knowledge)

    3 months post enrollment

  • Improvement in Adolescent Eating Disorder Symptoms (Eating Disorder Examination Questionnaire, Fairburn and Beglin, 1994; Subscale and global scores range from 0-6, with higher scores = greater symptom severity)

    3 months post enrollment

  • Improvement in Adolescent Percent median body mass index (%mBMI); %mBMI will be calculated using the adolescent participant's BMI from the first medical appointment in the study and expected median BMI for age and sex according to the CDC

    6 months after enrollment

  • +1 more secondary outcomes

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Participant receives individual and family therapy for Anorexia Nervosa, as well as regular medical and nutrition follow up appointments.

Behavioral: Treatment as usual for adolescents with Anorexia Nervosa

Treatment as Usual + Parent Educational Videos (PEV)

EXPERIMENTAL

Participant receives treatment as usual plus the 4 video Parent Educational Video series (psychoeducational for parents of adolescents with Anorexia Nervosa)

Behavioral: Parent Educational VideosBehavioral: Treatment as usual for adolescents with Anorexia Nervosa

Interventions

The PEV intervention includes four videos that a parent will watch online, each under 7 minutes. These psychoeducational videos were created by clinical psychologists specializing in treating adolescent eating disorders with Family Based Therapy techniques. The content of the videos includes: Video 1: Describes the severity of eating disorder symptoms, risk of short and long-term health problems; importance of intervention Video 2: How recovery works - Describes how eating is therapy - the role of parental food management, food exposure, etc. Video 3: Managing ED behaviors - Explains how to respond to food refusal, vomiting behaviors, over exercising behaviors, etc. Video 4: How to talk to your child when they are struggling

Treatment as Usual + Parent Educational Videos (PEV)

All study participants will receive the standard medical, nutrition, and mental health care as part of the eating disorder program at TCH. Medical and nutrition appointments typically occur every 1-3 months. Mental health appointments include 6 weeks of 3 hr/week group therapy, biweekly 1 hr a week individual therapy and biweekly 1 hr a week Family therapy.

Treatment as UsualTreatment as Usual + Parent Educational Videos (PEV)

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The adolescent must: • have had an initial medical evaluation by one of the Adolescent Medicine physicians at Texas Children's Hospital and be determined at that visit to have a restrictive eating disorder such as Anorexia Nervosa, Atypical Anorexia Nervosa, or Eating Disorder unspecified type.
  • The adolescent must between the ages of 10-16
  • The adolescent and their parent/guardian must be able to read and write English fluently

You may not qualify if:

  • Adolescent cannot have a comorbid diagnosis of Autism Spectrum Disorder or Intellectual Disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator / Assistant Professor of Pediatrics

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 5, 2026

Study Start

April 14, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations