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Gaining Real-Life Skills Over the Web (GROW)

2022년 3월 7일 업데이트: Children's Hospital Medical Center, Cincinnati

Gaining Real-Life Skills Over the Web (GROW)

Gaining Real-life Skills Over the Web (GROW) is an online parenting-skills intervention for caregivers of children aged 0-4 who sustained traumatic brain injuries. GROW is designed to promote family and child coping and adjustment for caregivers.

연구 개요

상태

완전한

상세 설명

This project develops and evaluates an online learning environment of web-based intervention modules designed to promote family and child coping and adjustment (GROW: Gaining Real-life Skills Over the Web) based on a comprehensive needs assessment of children aged 0 to 14 years old, who experienced a traumatic brain injury (TBI) between the ages of 0 to 4 years, and their families. The incidence of TBI peaks between the ages 0 to 4 years, yet there are no evidenced-based interventions to facilitate neurocognitive development and socio-emotional functioning of children injured during this critical development period. To address the unmet need of caregivers of infants and toddlers with TBI, the project uses a three-phase development process to generate proof of concept and initial proof of product. Phase 1 involves a comprehensive needs assessment that includes quantitative assessment of family and child needs, qualitative assessment through focus groups and interviews of families, feedback from family and professional advisory boards, and consultation with professionals implementing interventions with similar populations (e.g., families of children with very low birth weight). During Phase 2, the project develops the content and manual for the intervention modules, designs the online learning environment, and conducts intensive, iterative usability testing. Phase 3 involves a pilot of the GROW program with 20 families to evaluate its usability, acceptability, and qualitative and quantitative impact on stakeholder identified outcomes.

연구 유형

중재적

등록 (실제)

18

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Ohio
      • Cincinnati, Ohio, 미국, 45229
        • Cincinnati Children's Hospital Medical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1초 (어린이)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Age at injury and enrollment: ages 0-4, inclusive
  2. Overnight hospitalization for traumatic brain injury
  3. Mechanism of injury: Non-penetrating traumatic brain injury; abusive head trauma (AHT) will be included
  4. Language: English must be the primary spoken language in the home

Exclusion Criteria:

  1. Does not reside with the caregiver at least half-time
  2. The caregiving situation is not stable (i.e., there must be no scheduled custody hearings)
  3. English is not the primary language spoken in the home
  4. Families of children who are non-responsive or in a persistent vegetative state will also be excluded
  5. Caregivers with a psychiatric hospitalization in the past year will be ineligible to participate
  6. If AHT is the suspected injury mechanism, the child must not reside with the suspected abuser, must have been in the current living situation for at least 6 months, and must be anticipated to remain in this living situation for the next 6 months. The study team will only recruit non-abusing caregivers (including foster parents) to participate.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: GROW Intervention
Every participant received the GROW Intervention, chose not to participate in the GROW intervention, or dropped out before completing the GROW Intervention.
The highly interactive GROW Program consists of 5 core modules and 1 optional, supplemental session. Each session is expected to take 15-20 minutes to complete, and at the end of each module, parents record a 5 minute "special play time" video interacting with their child to demonstrate the skills they learned in the session. Each online module is followed by a meeting with a trained therapist who will discuss their "special play time" video and the skills they are learning. Parents make their way through the 5 core modules sequentially before accessing the supplemental session that may be relevant to them.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Center for Epidemiologic Studies Depression(CES-D) Scale Change
기간: Pre-Intervention and Immediately Post-Intervention
Measuring caregiver psychological distress, the CES-D consists of 20 items that are rated on a 4-point likert scale (from 1: rarely or none of the time to 4: most or all of the time). Scores range from zero to sixty. Higher scores indicated a higher frequency of depressive symptoms during the last week.
Pre-Intervention and Immediately Post-Intervention
Parenting Stress Index (PSI) Change
기간: Pre-Intervention and Immediately Post-Intervention
The study team used the 36 item short form PSI to measure caregiver stress. Using a 4-point likert scale, the stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.
Pre-Intervention and Immediately Post-Intervention
Patient-Reported Outcomes Measurement Information System Change
기간: Pre-Intervention and Immediately Post-Intervention
The study team used only the Sleep, Stress, and Anxiety Measures which are rated on a 5-point likert scale. Each measure has a range in score from 7 to 35 with higher scores indicating greater severity.
Pre-Intervention and Immediately Post-Intervention
Family Burden of Injury Interview (FBII) Change
기간: Pre-Intervention and Immediately Post-Intervention
The FBII measures family burden. Open-ended answers are coded Yes/No and are given a stress rating of 0 (not at all)-5(extremely stressful). Caregiver responses are averaged to provide an index of injury-related family burden.
Pre-Intervention and Immediately Post-Intervention
MacArthur-Bates Communicative Development Inventories (MB-CDI) Change
기간: Pre-Intervention and Immediately Post-Intervention
Using the short form MB-CDIs to measure child language abilities, the scoring scale is a minimum of 0- maximum of 310 with greater scores showing better language abilities.
Pre-Intervention and Immediately Post-Intervention
Caregiver-Child Observation Change
기간: Pre-Intervention and Immediately Post-Intervention
Using the Parent/Child Toy Play Ratings in the Play and Learning Strategies (PALS) manual, 6 domains (warmth, contingent responsiveness, demonstration/physical teaching, verbal stimulation/scaffolds, restrictions, and negativity/intrusiveness) are rated on scales of 1 to 5 with 1 being the worst rating and 5 being the best.
Pre-Intervention and Immediately Post-Intervention
GROW Satisfaction Survey
기간: Immediately Post-Intervention
Satisfaction with intervention measured in both 5-point likert scale ratings (with higher values showing greater satisfaction) and open-ended feedback about participant experience in the program.
Immediately Post-Intervention
Background & Family Information Form
기간: Pre-Intervention
Demographics rehabilitation services
Pre-Intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 9월 30일

기본 완료 (실제)

2021년 9월 30일

연구 완료 (실제)

2021년 9월 30일

연구 등록 날짜

최초 제출

2021년 8월 30일

QC 기준을 충족하는 최초 제출

2021년 12월 3일

처음 게시됨 (실제)

2021년 12월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 3월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 3월 7일

마지막으로 확인됨

2021년 9월 1일

추가 정보

이 연구와 관련된 용어

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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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