- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03356275
Mobile Coach for Parents of Children and Adolescents With Chronic Pain
Chronic pain is estimated to affect 20% to 35% of children and adolescents around the world, and is associated with increased risk of anxiety and depression among children and adolescents, as well as coping challenges, anxiety, depression, and anger in their parents. For parents, learning to manage stress is critical, as parents play a significant role in a child's experience of pain. Parental behaviors such as over-involvement, solicitousness and rejection are associated with decreased functioning, including higher school absenteeism in children and teens. A number of interventions demonstrate that teaching skills to parents can have a direct and positive impact on the health of children and adolescents with chronic pain. The investigators propose to create and test the BodiMojo Parent Buddy which will provide parents with real-time, tailored and adaptive coping and stress management support and will provide a curriculum of skills for responding to a child in pain in order to promote child functioning.
Thirty parents of children ages 8-18 who have been diagnosed with a non-cancer chronic pain condition will participate in this user-testing study. Parents will complete a brief set of questionnaires before and after the intervention, and will be instructed to open and use the app each day for 30 days. Participants will complete audio mindfulness exercises, watch brief video clips, and read psychoeducational information about pain, coping, and communication skills. Post-intervention questionnaires will also include an acceptance test to assess participants' opinions about the helpfulness and usability of the app. Parent participation is expected to take around 3.5 hours total over the 30 day study period.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90095
- UCLA Pediatric Pain and Palliative Care Program Research Offices
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Parents who self-report parenting a child or adolescent ages 8-18 with non-cancer chronic pain.
- Daily use of a smartphone (iOS, Android, or Windows) or tablet.
- Ability to speak and understand English.
Exclusion Criteria:
- Inability to provide consent
- Inability to speak and understand English
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Mobile application
Psychosocial support for parents, including: brief audio mindfulness recordings, videos, and psychoeducational materials.
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Mobile application focusing on emotional coping skills for parents of children and adolescents with chronic pain.
Components of the module include: library of mindfulness meditations/relaxations; peer support videos; and psychoeducational information related to pain, stress, and mindfulness.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Ratio of the days during the 30-day intervention period during which participants use the app
기간: At the conclusion of the final day of the intervention (Day 30)
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Determined by how often participants engaged and used certain features.
To be considered feasible, participants must have opened the app on at least half of the days.
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At the conclusion of the final day of the intervention (Day 30)
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Acceptance
기간: Within 7 days of competing the intervention
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Determined by participants' responses to acceptance test questions in the following domains: (1) how much the participant liked the various app features; (2) how much participants liked the video and supplementary content; and (3) helpfulness of various app features.
Responses will be given on a one to seven-point-scale ranging "terrible" to "excellent."
The intervention will be deemed acceptable if at least 80% of participants rate each question an average of at least "5" ("good") on the 7-point scale.
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Within 7 days of competing the intervention
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Lonnie K Zeltzer, MD, University of California, Los Angeles
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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