Traumatic Brain Injury Positive Strategies (TIPS)
Brain Injury Support and Strategies for Families Impacted by Childhood TBI
연구 개요
상세 설명
Due to the chronic nature of cognitive and behavioral problems related to TBI, parents and other family caregivers need information, resources, and training in evidence-based strategies to manage the varied and changing concerns following their child's injury. Recent research provides evidence that theory-driven, self-directed online parent training is effective in improving both child and parent outcomes.
The objective of this project is to produce the Traumatic Brain Injury Positive Strategies (TIPS) program, a comprehensive educational and training resource to help families improve their knowledge and skills to address cognitive, behavioral, and social challenges following pediatric TBI. The TIPS program will be grounded in the theory of planned behavior, which postulates that training in problem-solving leads to improved skills and increases in perceived behavioral control that mediate direct changes in parenting behaviors and indirect changes in child outcomes. The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI.
Approximately 216 family members will participate in the evaluation phase of this study. Participants will be randomly assigned to one of two conditions: (a) treatment (TIPS program ) or (b) control (brain injury website).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oregon
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Eugene, Oregon, 미국, 97403
- Center on Brain Injury Research and Training / University of Oregon
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult 18 years old or older
- Have a child age 3-18 that was hospitalized overnight with a traumatic brain injury (TBI).
- Involved in the care and support of the child with the TBI.
- Live in the same household as child with a TBI.
- The child with the TBI is able to follow simple instructions such as "please eat your toast."
Exclusion Criteria:
- Does not speak and read English.
- Does not have high speed Internet access.
- Not US resident
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: TIPS Intervention
The Traumatic Brain Injury Positive Strategies (TIPS) program, is a comprehensive educational and training resource to help families.
The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI.
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Web-based training for family member.
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활성 비교기: Control
An existing website related to traumatic brain injury.
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Traumatic Brain Injury website for family members.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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TIPS Change in Knowledge Survey
기간: Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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Survey to assess change in knowledge of research-based cognitive, behavioral, and social support strategies and self-efficacy about using those strategies in home and community settings.
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Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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PedsQL Family Impact
기간: Baseline and for a 3 month follow up after completed intervention.
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Administered to measure change in impact of pediatric acute and chronic health conditions on parents and the family.
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Baseline and for a 3 month follow up after completed intervention.
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Caregiver Self-Efficacy Scale
기간: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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25-question self-report measure, administered to measure the change in how comfortable caregivers feel about selected aspects of their parenting skills such as managing their child's behavior, being an advocate for their child, and dealing with school-related issues.
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Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The Pediatric Quality of Life Inventory (PedsQL)
기간: Baseline
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23 items measuring physical, emotional, social, and school function.
Caregiver report forms have been developed for children 2-18 years.
The PedsQL has been used in pediatric TBI as a quality of life outcome.
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Baseline
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PedsQL Cognitive Function
기간: Baseline
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Measures cognitive functioning in patients with acute and chronic health conditions as well as healthy school and community populations.
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Baseline
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Health Behavior Inventory (HBI)
기간: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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20 items measuring the change in frequency of common brain injury symptoms (somatic, cognitive, and emotional).
It will also be used to examine the effectiveness of the interventions in promoting symptom reduction.
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Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ann Glang, PhD, University of Oregon
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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