Parent Key Opinion Leaders to Increase Demand of Effective Treatments for Youth Anxiety (Project CHAT)

August 2, 2023 updated by: Temple University

Increasing Parent Demand for Evidence-Based Practices to Treat Youth Anxiety: The Effect of Parent Key Opinion Leaders

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
        • Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Researcher-Only
The researcher-facilitated presentation, led by two clinical psychology graduate students, will be the same for all schools.
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.
Experimental: Key Opinion Leader
The key opinion leader (KOL) co-facilitated presentations will include the same core principles as the researcher-facilitated presentation but may vary by school in terms of specific examples and content emphasized based on KOL feedback. A caregiver KOL from the local community (selected by the parent teacher association or a similar group) will co-facilitate the presentation with a clinical psychology graduate researcher.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Pre-Presentation to Post-Presentation in Treatment Seeking Evaluation - Intention to Seek Cognitive Behavioral Therapy
Time Frame: pre-presentation; post-presentation (within 1 week after the presentation)
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)
Number of Participants Who Sought Cognitive Behavioral Therapy as Assessed by Treatment Seeking Evaluation - Actual Cognitive Behavioral Therapy Seeking
Time Frame: 3-month follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Pre-Presentation to Post-Presentation in Parent Engagement in Evidence-Based Services Questionnaire, Knowledge Subscale
Time Frame: pre-presentation; post-presentation (within 1 week after the presentation)
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)
Change From Pre-Presentation to Post-Presentation in Therapy Subjective Norms Questionnaire
Time Frame: pre-presentation; post-presentation (within 1 week after the presentation)
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)
Change From Pre-Presentation to Post-Presentation in Caregiver Attitudes About Cognitive Behavioral Therapy
Time Frame: pre-presentation; post-presentation (within 1 week after the presentation)
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)
Change From Pre-Presentation to Post-Presentation in Parents' Internalized Stigma of Mental Illness Scale
Time Frame: pre-presentation; post-presentation (within 1 week after the presentation)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Pre-Presentation to Post-Presentation and to 3-Month Follow-Up in Barriers to Seeking Treatment
Time Frame: pre-presentation; post-presentation (within 1 week after the presentation)
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)
Change From Pre-Presentation to 3-Month Follow-Up in Barriers to Seeking Treatment
Time Frame: pre-presentation; 3-month follow-up
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
Client Satisfaction Questionnaire
Time Frame: post-presentation (within 1 week after the presentation)
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)
Relatability Evaluation
Time Frame: post-presentation (within 1 week after the presentation)
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)
Brief Revised Child Anxiety and Depression Scale-Parent Version
Time Frame: pre-presentation
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
Demographics
Time Frame: pre-presentation
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
Content Checklist
Time Frame: during the 1.5 hour presentation
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
Qualitative Interview
Time Frame: 3-month follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Philip C Kendall, Ph.D., Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 20, 2022

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26871
  • 1F31MH124346-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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