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Project Raising Exposure Awareness for Caregiver Help-Seeking (Project REACH)

5 de novembro de 2026 atualizado por: Hannah Frank, Brown University

A Direct-to-consumer Dissemination Campaign About Exposure to Increase Treatment Access

The goal of this pilot randomized study is to learn whether a dissemination campaign co-designed with a community advisory board helps caregivers of children with anxiety and related disorders seek exposure therapy, compared with standard information. Participants are caregivers of children ages 4 to 18 with current anxiety, OCD, or traumatic stress symptoms.

The main questions it aims to answer are:

Does the dissemination campaign improve caregivers' knowledge of exposure therapy, attitudes toward it, perceived norms about seeking it, and confidence that they can find an exposure therapist, compared with dissemination-as-usual?

Does the dissemination campaign increase caregivers' intentions to seek exposure therapy for their child, compared with dissemination-as-usual?

Researchers will compare the dissemination campaign to dissemination-as-usual, which is links to professional organization websites and advice to contact their insurance company or search an online therapist directory.

Participants will:

  • Complete an online survey about their help-seeking intentions, knowledge, attitudes, norms, and confidence
  • Be randomly assigned to review either the dissemination campaign or dissemination-as-usual materials for at least 10 minutes
  • Complete the same survey again right after reviewing the materials
  • Possibly be invited to a 15-minute phone interview 2 months later about whether they sought treatment for their child and what barriers they faced

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

Adult (age 18 or older) parent or other family caregiver Has a child aged 4 to 18 years with current symptoms of anxiety, obsessive-compulsive disorder (OCD), and/or traumatic stress, by caregiver report Able to read and understand English Able to provide informed consent

Exclusion Criteria:

Survey responses flagged as likely invalid or inaccurate during data screening, including uniform responding or duplicate or suspicious IP addresses Previous participation in this study

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Tailored Dissemination Campaign

Caregivers are randomized to review the community advisory board-designed dissemination campaign, including flyers, infographics, testimonial videos, and explainer video.

A direct-to-consumer dissemination campaign about exposure therapy for youth anxiety and related disorders, co-designed with a community advisory board of family caregivers and providers and refined through caregiver focus groups. It covers the same core content as standard information about finding mental health care, but uses terminology and explanations developed with the advisory board. It also includes a skills-focused "how-to" guide for finding and accessing an exposure therapist. The campaign targets help-seeking mechanisms from the Theory of Planned Behavior: knowledge, attitudes, perceived norms, and self-efficacy. Participants review the materials online for at least 10 minutes.

Comparador Ativo: Dissemination-as-usual

Caregivers are randomized to review standard information about finding mental health services for their child (e.g., information found via google and foundation websites)

Standard information about seeking mental health care for a child: links to professional organization websites and summary of information generated from Google searches. Participants review the materials online for at least 10 minutes.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Caregiver Self-Efficacy for Seeking Exposure Therapy
Prazo: Baseline (pre-review) and immediately post-review (same study session)

Self-efficacy for finding an exposure therapist for one's child, measured with two caregiver-report items rated on a 7-point agreement scale (e.g., "If I really wanted to, I could find an exposure specialist for my child"). The items are averaged into a score from 1 to 7, and higher scores indicate greater self-efficacy. Groups will be compared on the post-review score, controlling for baseline.

Baseline (pre-review) and immediately post-review (same study session)
Caregiver Attitudes Toward Exposure Therapy
Prazo: Baseline (pre-review) and immediately post-review (same study session)

Attitudes toward exposure therapy, measured with four standard semantic differential scales. The total score is the average of z-standardized items, and higher scores indicate more favorable attitudes. Groups will be compared on the post-review score, controlling for baseline.

Baseline (pre-review) and immediately post-review (same study session)
Perceived Norms for Seeking Exposure Therapy
Prazo: Baseline (pre-review) and immediately post-review (same study session)

Perceived norms about seeking exposure therapy, measured with two items rated on a 7-point agreement scale. One asks whether "other caregivers like me" would seek exposure therapy, and the other asks whether people important to the caregiver would approve. The items are averaged into a score from 1 to 7, and higher scores indicate more favorable perceived norms. Groups will be compared on the post-review score, controlling for baseline.

Baseline (pre-review) and immediately post-review (same study session)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Caregiver Intentions to Seek Exposure Therapy
Prazo: Baseline (pre-review) and immediately post-review (same study session)

Strength of caregivers' intentions to seek exposure therapy for their child, measured with two items rated on a 7-point scale: how willing and how likely the caregiver is to seek exposure therapy. The items are averaged into a score from 1 to 7, and higher scores indicate stronger intentions. Groups will be compared on the post-review score, controlling for baseline.

Baseline (pre-review) and immediately post-review (same study session)
Caregiver Knowledge of Exposure Therapy
Prazo: Baseline (pre-review) and immediately post-review (same study session)

Caregiver awareness of and prior experience with exposure therapy, measured with a previously developed two-item measure. Groups will be compared on the post-review score, controlling for baseline.

Baseline (pre-review) and immediately post-review (same study session)
Acceptability of Dissemination Strategies
Prazo: Immediately post-review (same study session)

Caregiver ratings of the acceptability of each dissemination strategy developed with the community advisory board.

Immediately post-review (same study session)
Caregiver-Reported Connection to Mental Health Services
Prazo: 2 months post-review

Number of caregivers in a purposive subsample (n=32; 16 per arm, selected for high or low baseline intentions) who report successfully connecting their child with mental health services, and the type of treatment sought (including exposure therapy). This is assessed in a 15-minute structured phone interview. Reported barriers to accessing care and the influence of study materials on help-seeking will be analyzed qualitatively with rapid qualitative analysis, using codes from the Theory of Planned Behavior.

2 months post-review

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de janeiro de 2027

Conclusão Primária (Estimado)

15 de junho de 2027

Conclusão do estudo (Estimado)

31 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

5 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de novembro de 2026

Primeira postagem (Real)

10 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • STUDY00000708
  • U54GM115677 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

De-identified individual participant data from the quantitative surveys will be shared, including baseline and post-review measures of help-seeking intentions, knowledge, attitudes, perceived norms, self-efficacy, and acceptability, along with de-identified demographic and child symptom data. Qualitative interview transcripts will not be shared, to protect participant confidentiality.

Prazo de Compartilhamento de IPD

Data will be available beginning 6 months after publication of the primary results and for at least 3 years after that.

Critérios de acesso de compartilhamento IPD

Data will be available to qualified researchers who submit a methodologically sound proposal to the study PI and sign a data use agreement

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .