- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01804582
The Family VOICE Study
The Family VOICE Study (Value, Information, Community Support, and Experience): A Randomized Trial of Family Navigator Services Versus Usual Care for Care of Young Children Treated With Antipsychotic Medication
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21201
- University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Child 2 to 15 years old who has been approved by the Maryland Medicaid program for treatment with an antipsychotic medication.
Exclusion Criteria:
Department of social services custody
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Family Navigator Consultation
This group of parents will be contacted by a Family Navigator to assist them in accessing psychosocial resources based on their child and family needs. Components of this intervention are the following: (1)family engagement; (2) inquiry about psychosocial resource needs related to schools, outpatient child treatment, support programs, or mental health resources for other household family members; (3) discuss potential benefits/challenges of options and parent preferences/priorities for care; (4) assessment on perceived barriers to seeking resources; (5) collaborative problem solving to address barriers; (6) discuss options for follow up plan. |
Telephone contact from the trained family navigator to the parent participant several times over the 90 day study time period. Components of the service include the following: (1)family engagement; (2) inquiry about psychosocial resource needs related to schools, outpatient child treatment, support programs, or mental health resources for other household family members; (3) discuss potential benefits/challenges of options and parent preferences/priorities for care; (4) assessment on perceived barriers to seeking resources; (5) collaborative problem solving to address barriers; (6) discuss options for follow up plan.
다른 이름들:
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간섭 없음: Usual Care
No specific study intervention is provided to this group of parents.
This control group will received the usual care that they have been receiving from their child's providers.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Family Empowerment Scale
기간: Change from baseline to 90 days
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This 34-item, Likert scale with scores ranging from 1 (never) to 5 (very often) which measures parent empowerment related to caring for their child with special needs.
Higher scores indicate a greater sense of parental empowerment in caring for their child, interacting with the services system and contributing to the community.
The sub scales have demonstrated good reliability and validity, and provide comprehensive information about empowerment, including attitudes, knowledge, and behaviors.
A composite score was calculated for each participant with the range 1-5 (1 never to 5 very often)based on the average of their item scores with higher scores indicating better outcomes.
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Change from baseline to 90 days
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Duke-UNC (University of North Carolina) Functional Social Support Questionnaire
기간: Change from Baseline to 90 days
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This 14 item questionnaire assesses confidant ("e.g.
"I get chances to talk to someone I trust about family problems."),
affective ("People care what happens to me."), and instrumental ("I can get help when I need transportation support.").
In a validation sample, the measure was found to have good internal consistency and it correlated with related domains of psychosocial functioning in expected directions.
This measure has been widely used to assess social support among both identified medical and mental health patients as well as their family members.
A composite score was calculated for each participant with the range 1-5 (1 As much as I would like to 5 Much less than I would like) based on the average of their item scores.
The range of scores is from 1-5 with lower scores indicating better functional social support.
Subscales were not analyzed.
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Change from Baseline to 90 days
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Youth Services Survey for Families
기간: Change from Baseline to 90 days
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This 26-item questionnaire specifically targets parents' satisfaction with children's mental health services.
The measure assesses five domains of parent satisfaction: cultural sensitivity, access, treatment participation, appropriateness, and outcome.
This measure has been adopted by several State mental health systems to evaluate parent satisfaction with child services.
A composite score was calculated for each participant with the range 1-5 (1 Strongly Disagree to 5 Strongly Agree) based on the average of their item scores.
Range of scores is from 1-5 with higher scores indicating better functional social support.
Subscales were not analyzed.
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Change from Baseline to 90 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Child Behavior Checklist - Brief Problem Monitor
기간: Change from Baseline to 90 days
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We will use the preschool (ages 1 ½-5) and school age (6-12) versions of this measure, which asks parents to rate items about behavioral and emotional problems on a 0-2 scale.
Both versions provide a Total Problem Score.
These measures have been widely used in pediatric mental health research.
The Brief Problem Monitor provides T scores for the total problem score and it ranges from 0-80, with higher T scores indicating more mental health difficulties.
Subscales of this measure were not analyzed.
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Change from Baseline to 90 days
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Psychosocial Service Utilization
기간: Change from Baseline to 90 days
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We will utilize total Medicaid claims data for any psychosocial services claims (e.g.
individual, family, or group psychotherapy; parenting groups) to collect information on services used in the 90 days prior to the baseline and over the 90 days of participant enrollment in the study.
Participants were considered to have received psychosocial claims (dichotomous Yes/No) if they received any individual, family, or group psychotherapy in the 90 days prior and during the study period.
Higher numbers indicate more participants received at least 1 psychosocial service claim.
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Change from Baseline to 90 days
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Medication Regimen
기간: Change from Baseline to 90 days
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We will utilize Medicaid pharmacy prescription data collect information at baseline and 90 days on the name and dose of all psychiatric medications prescribed at those time points.
Participants were designated increase or no increase in their dosage of antipsychotic medication (i.e., dichotomous Yes/No) over the 90 day intervention period.
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Change from Baseline to 90 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gloria M Reeves, M.D., University of Maryland, Baltimore
간행물 및 유용한 링크
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 (추정)
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
- HP-00054913
- 1300476 (기타 식별자: Patient Centered Outcome Research Institute (PCORI))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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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