- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07929077
Project Raising Exposure Awareness for Caregiver Help-Seeking (Project REACH)
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
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Hannah E Frank, PhD
- Numer telefonu: 401-444-1941
- E-mail: hannah_frank@brown.edu
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Aktywny komparator: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Caregiver Self-Efficacy for Seeking Exposure Therapy
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Caregiver Intentions to Seek Exposure Therapy
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STUDY00000708
- U54GM115677 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Ramy czasowe udostępniania IPD
Data will be available beginning 6 months after publication of the primary results and for at least 3 years after that.
Kryteria dostępu do udostępniania IPD
Data will be available to qualified researchers who submit a methodologically sound proposal to the study PI and sign a data use agreement
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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