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The Family VOICE Study

2019년 11월 1일 업데이트: Gloria Reeves, University of Maryland, Baltimore

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

Family centered mental health treatment with children values and supports the role of parents in their child's recovery. However, medications are often the primary focus in community treatment, even in preschool age youth, with increasing use of antipsychotic medication for serious mood and behavior problems. Although medication may be necessary to address safety issues (such as severe aggression) it can cause serious side effects, such as obesity, and medication only does not follow recommended care for these types of problems. Psychosocial treatments are highly recommended (e.g. Programs that coach empower parents to manage their child's difficult behaviors) as part of comprehensive child treatment. Parent involvement in psychosocial treatment has clear benefits for their child's mental health, and unlike medication, the effects can last long after treatment is completed. However, problems related to access (e.g. long waiting lists) and use (e.g. parent mistrust mental health services) of services are common. Maryland, like other states, has developed a system to improve medication safety by reviewing health information about the child to determine if the treatment is appropriate. This reduces unnecessary medication treatment and ensures children have adequate health screening before starting any treatment. Those approved for medication have moderate-severe mental health problems, which supports their need for comprehensive (medication and psychosocial) treatment, instead of medication only. In this study, investigators partner with parents/family advocates, child-serving agencies, and health providers to develop a Family Navigator (FN) Service to link with this medication program. A FN is an individual who has cared for their own child with mental illness. The FN supports parents, provide information on psychosocial treatment options, and address barriers to using services. The goals of this program are to improve use of psychosocial services, and to improve parent empowerment, support, and satisfaction with their child's mental health treatment. The investigators also expect that the FN Service will improve the child's overall mental health and reduce the likelihood of a medication dose increase or another medication added during the initial treatment period. The FN Service is provided for parents of public insured children ages 3-15 years newly approved for antipsychotic medication treatment. The FN Services will be provided by phone, which supports families in both rural and urban settings. The investigators' long term goal is to develop a FN program that strongly supports Family-centered treatment of children and can be used to help families in other underserved areas beyond Maryland.

연구 개요

상세 설명

Background: Emerging data on serious antipsychotic medication side effects (e.g. new onset diabetes)has heightened concerns about sharp increases in "off label" pediatric antipsychotic treatment of mood/behavioral disorders, and led to increased scrutiny of pediatric mental health treatment. Several states are developing antipsychotic medication pre-authorization programs to reduce inappropriate or unsafe prescribing. This Healthcare system change, however, fails to address a critical underlying problem that parents are not effectively engaged to utilize non-medication treatments and serve an active role in their child's mental health recovery. Psychosocial treatments (e.g. parenting skills training to manage aggressive behaviors) are evidence-based interventions that are poorly utilized in community care. The Maryland Medicaid program developed a pediatric Antipsychotic Pre-Authorization Program that requires providers to make at least one psychosocial treatment referral in order to obtain medication approval. This program was shaped by strong input from parents, health experts, and child serving agency administrators to promote psychosocial treatment referral, but it does not provide any Family-centered services to improve treatment utilization. Objectives: We propose to link the Antipsychotic Pre-Authorization Program with a Family Navigator Service. The investigators will examine if Navigator Services improve parent empowerment, support, and satisfaction with child services. The investigators will also assess if Navigator Services are associated with improved psychosocial service utilization, improved child functioning, and lower likelihood of medication increases (higher dose or addition of another medication). The investigators' long term objective is to develop a Family Navigator model that is highly portable, amenable for use in underserved areas, addresses the needs of low income families with young children, and promotes evidence-based mental health care. Methods: The investigators will conduct a randomized trial of a telephone Family Navigator Service versus usual care for 240 Medicaid insured youth 10 years old who are approved for antipsychotic medication treatment. The Family Navigator is a parent who has experienced their own child's mental illness. Navigators will provide support, information on psychosocial treatment options, and options to address barriers to care. The investigators will assess family-centered outcomes at baseline and 90 days (medication re-authorization). The investigators will use generalized linear mixed effects models with the appropriate link functions to assess whether there is a significant difference in improvement from baseline to the post-treatment assessment on the outcome variables between the Family Navigator condition and treatment as usual condition. A significant interaction between time and study condition would support the hypothesis that a Family Navigator will improve parent and child outcomes.

연구 유형

중재적

등록 (실제)

350

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • University of Maryland, School of Medicine, Department of Psychiatry, Division of Child and Adolescent Psychiatry

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

2년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

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

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

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
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:
  • Patient navigator services
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Family Empowerment Scale
기간: Change from baseline to 90 days
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.
Change from baseline to 90 days
Duke-UNC (University of North Carolina) Functional Social Support Questionnaire
기간: Change from Baseline to 90 days
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.
Change from Baseline to 90 days
Youth Services Survey for Families
기간: Change from Baseline to 90 days
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.
Change from Baseline to 90 days

2차 결과 측정

결과 측정
측정값 설명
기간
Child Behavior Checklist - Brief Problem Monitor
기간: Change from Baseline to 90 days
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.
Change from Baseline to 90 days
Psychosocial Service Utilization
기간: Change from Baseline to 90 days
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.
Change from Baseline to 90 days
Medication Regimen
기간: Change from Baseline to 90 days
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.
Change from Baseline to 90 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Gloria M Reeves, M.D., University of Maryland, Baltimore

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)

2013년 5월 1일

기본 완료 (실제)

2016년 3월 31일

연구 완료 (실제)

2016년 3월 31일

연구 등록 날짜

최초 제출

2013년 2월 27일

QC 기준을 충족하는 최초 제출

2013년 3월 1일

처음 게시됨 (추정)

2013년 3월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 11월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 11월 1일

마지막으로 확인됨

2019년 11월 1일

추가 정보

이 연구와 관련된 용어

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?

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. .

Family Navigator consultation에 대한 임상 시험

구독하다