Anxiety DisordersProject CHATNCT04929262
Parent Key Opinion Leaders to Increase Demand of Effective Treatments for Youth Anxiety
A study testing Supporting Anxious Youth: Strategies for Caregivers in people with Anxiety Disorders, run by Temple University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Supporting Anxious Youth: Strategies for Caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- Supporting Anxious Youth: Strategies for Caregivers
- Keywords
- dissemination, key opinion leader, direct-to-consumer marketing, healthcare utilization, evidence-based practice, youth anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supporting Anxious Youth: Strategies for CaregiversBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Researcher-Only | Active comparator | The researcher-facilitated presentation, led by two clinical psychology graduate students, will be the same for all schools. Receives: Behavioral: Supporting Anxious Youth: Strategies for Caregivers |
| Key Opinion Leader | Experimental | 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. Receives: Behavioral: Supporting Anxious Youth: Strategies for Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 3-month follow-up
Secondary outcomes (4)
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.
Measured: pre-presentation; post-presentation (within 1 week after the presentation)
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.
Measured: pre-presentation; post-presentation (within 1 week after the presentation)
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.
Measured: 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
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.
Measured: pre-presentation; post-presentation (within 1 week after the presentation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start3 May 2021
- Primary completion15 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Illinois Chicago, Brown University, Drexel University
- Responsible party
- Sponsor
- Investigators
- Philip C Kendall, Ph.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929262
- Sponsor's protocol ID
- 26871
- Other IDs
- 1F31MH124346-01
- Acronym
- Project CHAT
- Status last verified
- Aug 2023
- First submitted
- 3 Jun 2021
- Last updated
- 23 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crane ME, Atkins MS, Becker SJ, Purtle J, Olino TM, Kendall PC. The effect of caregiver key opinion leaders on increasing caregiver demand for evidence-based practices to treat youth anxiety: protocol for a randomized control trial. Implement Sci Commun. 2021 Sep 23;2(1):107. doi: 10.1186/s43058-021-00213-x.
PubMed 34556182
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Parent Demand for Evidence-Based Practices to Treat Youth Anxiety: The Effect of Parent Key Opinion Leaders
- ClinicalTrials.gov ID
- NCT04929262
- Acronym / sponsor ID
- Project CHAT / 26871
- Conditions
- Anxiety Disorders
- Keywords
- dissemination, key opinion leader, direct-to-consumer marketing, healthcare utilization, evidence-based practice, youth anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Illinois Chicago, Brown University, Drexel University
- Study start
- 3 May 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Posted 23 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Researcher-Only | Active comparator | Behavioral: Supporting Anxious Youth: Strategies for CaregiversThe researcher-facilitated presentation, led by two clinical psychology graduate students, will be the same for all schools. |
| Key Opinion Leader | Experimental | Behavioral: Supporting Anxious Youth: Strategies for CaregiversThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supporting Anxious Youth: Strategies for CaregiversThe 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. | Behavioural | Key Opinion Leader, Researcher-Only |
Primary outcome
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).
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.
4 secondary outcomes
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)
Change From Pre-Presentation to Post-Presentation in Therapy Subjective Norms Questionnaire
Time frame: 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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34556182Crane ME, Atkins MS, Becker SJ, Purtle J, Olino TM, Kendall PC. The effect of caregiver key opinion leaders on increasing caregiver demand for evidence-based practices to treat youth anxiety: protocol for a randomized control trial. Implement Sci Commun. 2021 Sep 23;2(1):107. doi: 10.1186/s43058-021-00213-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip C Kendall, Ph.D. principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supporting Anxious Youth: Strategies for Caregivers in people with Anxiety Disorders, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04929262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.