- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hannah E Frank, PhD
- Phone Number: 401-444-1941
- Email: hannah_frank@brown.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
|
Active Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver Self-Efficacy for Seeking Exposure Therapy
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver Intentions to Seek Exposure Therapy
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000708
- U54GM115677 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
Data will be available beginning 6 months after publication of the primary results and for at least 3 years after that.
IPD Sharing Access Criteria
Data will be available to qualified researchers who submit a methodologically sound proposal to the study PI and sign a data use agreement
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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