- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07566546
The Role of a Brief Educational Video Series for Parent of Adolescents With Anorexia Nervosa
The Role of a Brief Educational Video Series for Parent of Adolescents With Anorexia Nervosa: Feasibility, Acceptability, and Initial Efficacy to Improve Parent and Patient Outcomes
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.
연구 개요
상태
상세 설명
Eligible participants are a parent or guardian of an adolescent who has been diagnosed with a suspected eating disorder by a medical provider at Texas Children's Hospital (TCH). Parents have told the investigators that they needed more information about their child's eating disorder and treatment at the onset of their child's diagnosis. The purpose of this study is to determine if brief parental educational videos are feasible, acceptable, and provide increased knowledge for parents of adolescents newly diagnosed with eating disorders.
The purpose of this pilot study is to see if families are willing and interested in brief educational videos. The investigators are also interested if the videos help support parents through increased knowledge about eating disorder treatment, improved self-efficacy, and reducing stress associated with treatment. A final goal is to see if the intervention helps adolescents recover faster.
Procedures
The research will be conducted at the following location(s):
Baylor College of Medicine and TCH: Texas Children's Hospital.
Day of Enrollment:
Once a parent consents to participate in the study, they are assigned to either receive treatment as usual (TAU) or TAU plus the parent educational videos (PEV). This assignment is random and every parent has a 50/50 chance of being assigned to one group or the other. Regardless of group assignment, all parents and their adolescent will receive treatment as usual in the eating disorder program at TCH.
Within 1 week of Enrollment:
Parents in both groups will be asked to complete demographic questions and standardized measures of eating disorder knowledge, parental stress and burden, motivation, and parental self-efficacy. The adolescent will be asked to complete a standardized measure of mental health symptoms, including a measure of depression, anxiety, and eating disorder symptoms. The parent measures should take 10-20 minutes to complete. The adolescent measures should take 5-10 minutes to complete. If a parent is assigned the PEV intervention they will be asked to also watch four videos online each under 7 minutes and complete questions related to their satisfaction of the video content and knowledge gained through the videos. The video content 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
3 months after enrollment:
Parents in both groups will be asked to complete the questionnaires again 3 months later. Adolescent participants will be asked to complete the same measure again 3 months later. The parent questionnaires should take 10-20 minutes to complete. The adolescent participant questionnaire should take 5-10 minutes to complete.
6 months after enrollment:
Adolescents will be scheduled for a medical or nutrition appointment to collect data on their weight and health related changes. This is a standard appointment for all patients in the investigator's Adolescent Medicine clinic but the data collected at that visit will be used to understand how the adolescent participant's weight and health related outcomes have been impacted by treatment with or without the PEV intervention.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- Texas Children's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- Adolescent cannot have a comorbid diagnosis of Autism Spectrum Disorder or Intellectual Disability
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Treatment as Usual
Participant receives individual and family therapy for Anorexia Nervosa, as well as regular medical and nutrition follow up appointments.
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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.
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실험적: Treatment as Usual + Parent Educational Videos (PEV)
Participant receives treatment as usual plus the 4 video Parent Educational Video series (psychoeducational for parents of adolescents with Anorexia Nervosa)
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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.
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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility: The investigators will measure feasibility by determining how many parent-adolescent dyads that meet eligibility criteria actually enroll in the study.
기간: 1 year for recruitment
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Is the PEV intervention feasible?
Do at least 70% of families eligible for enrollment, agree to enroll in the study and watch the videos.
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1 year for recruitment
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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.
기간: within 30 days of enrollment in the study
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Acceptability: The investigators will measure acceptability by the following parental self-report questions:
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within 30 days of enrollment in the study
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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)
기간: 3 months from enrollment in the study
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The Brief Parental Self-Efficacy Scale (Woolgar et al., 2025) will be used to assess parental self-efficacy at baseline and then 3 months later to determine if parents in the intervention arm of the study have greater improvement in self-efficacy total scores compared to parents in the control group (treatment as usual).
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3 months from enrollment in the study
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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)
기간: 3 months post enrollment
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The Parental Burnout Assessment (Roskam et al., 2018) will be used to assess parental stress and burnout at baseline and then 3 months later to determine if parents in the intervention arm of the study have greater improvement in parental stress and burnout total scores compared to parents in the control group (treatment as usual).
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3 months post enrollment
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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)
기간: 3 months post enrollment
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The Parent Anorexia Knowledge Questionnaire (PAK-Q) is a 15-item multiple choice questionnaire assessing parental knowledge of anorexia nervosa, including the most evidence-based treatments, how to manage food refusal at home, how to engage in food based exposures, and how to communicate best when a child is struggling with an eating disorder.
The PAK-Q will be used to assess parental knowledge at baseline and then 3 months later to determine if parents in the intervention arm of the study have greater improvement in knowledge total scores compared to parents in the control group (treatment as usual).
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3 months post enrollment
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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)
기간: 3 months post enrollment
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The Eating Disorder Examination Questionnaire will be used to assess eating disorder symptoms at baseline and then 3 months later to determine if adolescents in the intervention arm of the study have greater improvement in eating disorder symptoms (total scale score) compared to adolescents in the control group (treatment as usual).
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3 months post enrollment
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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
기간: 6 months after enrollment
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Hypothesis: adolescents in the intervention arm of the study will demonstrate gerater improvement in %mBMI compared to adolescents in the control group (Treatment as usual).
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6 months after enrollment
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Improvement in Adolescent Percent Target Goal Weight (TGW). An adolescent's %TGW is calculated as current weight divided by treatment goal weight, then multiplied by 100. The TGW is individualized from growth history, height, puberty stage, and prior BMI
기간: 6 months post enrollment
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Highest reported weight and intake height, age, and sex will be used to calculate each adolescent participant's highest lifetime BMI.
Target Goal Weight (TGW) will be determined by averaging the most recent lowest and highest pre-illness BMI percentile values at intake and follow up appointments.
Participants are considered "in recovery" at or above 95% of their TGW.
Lower %TGW indicate more disease severity.
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6 months post enrollment
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- H-58691
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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