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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04929262
Other study ID # 26871
Secondary ID 1F31MH124346-01
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2021
Est. completion date July 20, 2022

Study information

Verified date August 2023
Source Temple University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Despite research identifying effective treatments for youth anxiety, parents (and other primary caregivers) are unaware that some treatments are more effective than others. This study investigates whether having a local parent key opinion leader co-facilitate an educational outreach presentation on effective treatment for youth anxiety will increase parent demand for evidence-based practices (EBPs). It is hypothesized that participants who receive a presentation co-presented by a key opinion leader will be more likely to have sought cognitive behavioral therapy for their child at the three-month follow up, relative to participants who receive a presentation presented by two researchers.


Description:

Anxiety disorders are common among adults and youth and, when left untreated, are associated with several long-term negative sequelae. Although research has identified a number of EBPs for treating youth anxiety (in particular, cognitive behavioral therapy [CBT] with exposures) and despite large-scale implementation efforts, few youth receive EBPs. Direct-to-consumer marketing offers a different approach to increase provider uptake of EBPs by increasing parent demand for EBPs. Direct-to-consumer initiatives are especially important given patient-barriers that prevent youth from receiving treatment, including lack of parental knowledge of EBPs and stigma associated with mental health treatment. Although parent preferences for receiving information about EBPs vary based on demographic factors and individual experiences, research has not investigated methods of tailoring direct-to- consumer efforts to local contexts. Involving a local parent key opinion leader (KOL) to tailor direct-to- consumer initiatives to local contexts may be an effective strategy to increase parent demand for EBPs. KOLs are credible and trustworthy members of a local community who can use their social influence to disseminate information and validate messages about EBPs. Research indicates that KOLs improve health promotion campaigns, but KOLs have not been studied in the context of increasing parent demand for EBPs. The project will examine the role of KOL participation in conducting outreach presentations to increase parent desire to seek CBT for their youth's anxiety. Parent attendees (or primary caregivers; N = 180) will be cluster-randomized by school to one of two different approaches for presentations on EBPs for youth anxiety (90 parents per condition). Both approaches will include community outreach presentations providing information about youth anxiety, effective treatments for youth anxiety, and seeking CBT for youths. The researcher-only condition will be co-facilitated by two researchers. In the KOL condition, a parent KOL from each local community will be involved in tailoring the content of the presentation to the context of the community, co-facilitating the presentation with a researcher, and endorsing strategies in the presentation that they have found to be helpful. The parent-teacher association (or a similar group of parents) from each school will nominate a parent who is well-known and well-respected within their community as the KOL. Parent attendees for both conditions will be recruited by contacting school mental health workers/other school administrators, who will advertise the presentations via their school email list and fliers sent home with children. Parent attendees will complete measures assessing their knowledge of, attitudes towards, and intention to seek CBT pre- and post- presentation, and they will indicate whether they sought CBT for their youth at a three-month follow-up. This study will use a mixed methods approach (integrating quantitative and qualitative methods) to test the effect of KOLs on increasing caregiver demand for CBT for youth anxiety. Primary aims test the relative effects of researcher-only and KOL conditions on changing caregivers' intention to seek CBT for their youth, and actual CBT seeking at three-month follow up. Secondary aims examine (1) the relative effects of researcher-only and KOL conditions on changing caregivers' perceived subjective norms about seeking CBT, attitudes about CBT, stigma about mental illness, and knowledge of how to seek EBPs; and (2) how KOLs affect participants' impression of the researcher presenter. This study will provide future direct-to-consumer efforts with evidence about effective strategies to increase parent demand for EBPs, which in turn will enable parents to seek the best care for their child.


Recruitment information / eligibility

Status Completed
Enrollment 301
Est. completion date July 20, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Be least 18 years of age - Be fluent in English - Be the primary caregiver of a youth aged 5 to 18 years - Have a child at one of the schools offering a presentation Exclusion Criteria: • None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Supporting Anxious Youth: Strategies for Caregivers
The outreach presentation will last 75 minutes with an additional 15 minutes for caregiver questions. The presentations will occur in the evening via Zoom. The presentation will include information about identifying anxiety disorders, strategies for caregivers to help their youth with anxiety, evidence-based practices to treat youth anxiety, and strategies for finding a therapist who uses cognitive behavior therapy with exposures. The text on the presentations is written at a 5.3 grade reading level. Presentations will incorporate stigma reduction strategies, such as education to dispel myths, and behavioral decision-making tools to elicit hope, empowerment, and motivation.

Locations

Country Name City State
United States Temple University Philadelphia Pennsylvania

Sponsors (5)

Lead Sponsor Collaborator
Temple University Brown University, Drexel University, National Institute of Mental Health (NIMH), University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change From Pre-Presentation to Post-Presentation and to 3-Month Follow-Up in Barriers to Seeking Treatment The Barriers to Seeking Treatment questionnaire asks participants to indicate whether they agree with 21 potential barriers to treatment (yes/no). A count of the total number of barriers will be used in analyses. pre-presentation; post-presentation (within 1 week after the presentation)
Other Change From Pre-Presentation to 3-Month Follow-Up in Barriers to Seeking Treatment The Barriers to Seeking Treatment questionnaire asks participants to indicate whether they agree with 21 potential barriers to treatment (yes/no). A count of the total number of barriers will be used in analyses. pre-presentation; 3-month follow-up
Other Client Satisfaction Questionnaire The Client Satisfaction Questionnaire assesses participants' satisfaction with the presentation. Items are rated on scale ranging from 1 to 4. Items are summed; higher composite scores indicate greater program satisfaction. post-presentation (within 1 week after the presentation)
Other Relatability Evaluation The Relatability Evaluation will be used to evaluate participants' impression of the presenter. Participants will rate each presenter (scale ranging from 1 to 5) on 10 items associated with aspects of key opinion leaders: relatable, likeable, similar, think similarly, similar beliefs, credible, trustworthy, understanding of the local community, familiar, and friendship. Items are summed; higher composite scores indicate that the presenter is more relatable. post-presentation (within 1 week after the presentation)
Other Brief Revised Child Anxiety and Depression Scale-Parent Version The total anxiety scale (15 items) from the Brief Revised Child Anxiety and Depression Scale-Parent Version will be used to assess youth anxiety (Ebesutani et al., 2017). Participants rate items on a scale from 0 (never) to 3 (always). Items are summed; higher scores indicate higher levels of anxiety. pre-presentation
Other Demographics A demographics questionnaire will assess caregiver and youth age, gender, race, ethnicity, and nativity; caregiver level of education, income, and religion; and youth health insurance status. pre-presentation
Other Content Checklist A content checklist will assess the core components of the presentation, as well as presenter and audience member self-disclosure about experiencing receiving therapy for themselves or their child (yes/no). Self-disclosure will be considered to have been made if either the presenter or an audience member self-discloses about their experiences. during the 1.5 hour presentation
Other Qualitative Interview A qualitative interview will ask participants about the following topics: (1) their perception of presenters; (2) ways in which the presenters affected their decision to seek treatment; (3) factors they considered when seeking treatment; (4) strategies they have used from the presentation; (5) their perception of exposure therapy; and (6) general ways that the mental health system could be improved to improve access to therapy. 3-month follow-up
Primary Change From Pre-Presentation to Post-Presentation in Treatment Seeking Evaluation - Intention to Seek Cognitive Behavioral Therapy Participants rate how likely they are to seek a therapist who uses exposure therapy for their child in the next three months on a scale ranging from 1 (very unlikely) to 5 (very likely). pre-presentation; post-presentation (within 1 week after the presentation)
Primary Number of Participants Who Sought Cognitive Behavioral Therapy as Assessed by Treatment Seeking Evaluation - Actual Cognitive Behavioral Therapy Seeking Participants indicate whether they sought exposure therapy for their child since the presentation. Participants were first ask if they sought therapy for their child. If yes, they were asked if they sought exposure therapy for their child (options were yes, no, unsure). The count provided is the number of participants that responded "yes" they sought exposure therapy for their child. 3-month follow-up
Secondary Change From Pre-Presentation to Post-Presentation in Parent Engagement in Evidence-Based Services Questionnaire, Knowledge Subscale The Parent Engagement in Evidence-Based Services Questionnaire, Knowledge subscale assesses caregiver perceived understanding of how to seek evidence-based practice. Participants rate five items on a ranging from 1 (strongly disagree) to 5 (strongly agree). Items are averaged to create the Parent Engagement in Evidence-Based Services Questionnaire, Knowledge subscale (subscale range = 1-5); higher scores indicate higher levels of perceived knowledge about seeking evidence-based practice. pre-presentation; post-presentation (within 1 week after the presentation)
Secondary Change From Pre-Presentation to Post-Presentation in Therapy Subjective Norms Questionnaire The Therapy Subjective Norms Questionnaire is a six-item measure of caregiver perception of subjective norms for seeking cognitive behavioral therapy. Items are rated on a scale ranging from 1 (strongly disagree) to 7 (strongly agree). Items are summed to create a total score (range = 6 - 42); higher scores indicate more positive subjective norms about seeking therapy. pre-presentation; post-presentation (within 1 week after the presentation)
Secondary Change From Pre-Presentation to Post-Presentation in Caregiver Attitudes About Cognitive Behavioral Therapy The Caregiver Attitudes about Cognitive Behavioral Therapy includes 18 strategies used in cognitive behavioral therapy for youth anxiety. Participants rate how helpful they believe each strategy would be for treating their child on a five-point scale ranging from 1 (very unhelpful) to 5 (very helpful). Items are summed to create a total score (range = 18 - 90); higher scores indicate more favorable attitudes. pre-presentation; post-presentation (within 1 week after the presentation)
Secondary Change From Pre-Presentation to Post-Presentation in Parents' Internalized Stigma of Mental Illness Scale The Parents' Internalized Stigma of Mental Illness Scale (PISMIS) assesses caregiver perception of internalized stigma for having a youth with a mental illness (Zisman-Ilani et al., 2013). Participants rate 10 statements on a scale ranging from 1 (strongly disagree) to 4 (strongly agree); some items are reverse scored. Items are summed to create a total score (range = 10-40); higher scores indicate higher levels of family stigma. pre-presentation; post-presentation (within 1 week after the presentation)
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