Trial Outcomes & Findings for Parent Key Opinion Leaders to Increase Demand of Effective Treatments for Youth Anxiety (NCT NCT04929262)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

301 participants

Primary outcome timeframe

pre-presentation; post-presentation (within 1 week after the presentation)

Results posted on

2023-08-23

Participant Flow

Elementary, middle, and high schools located within a 1.5-hour drive of Philadelphia were recruited by emailing their school mental health workers/other school administrators. School administrators advertised presentations as they advertise other school events (e.g., email list, Facebook groups).

Unit of analysis: School

Participant milestones

Participant milestones
Measure	Researcher-Only The researcher-facilitated presentation, led by two clinical psychology graduate students, will be the same for all schools. 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.	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. 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.
Pre-Presentation Questionnaires STARTED	152 14	131 13
Pre-Presentation Questionnaires COMPLETED	112 13	97 12
Pre-Presentation Questionnaires NOT COMPLETED	40 1	34 1
Attended Presentation STARTED	112 13	97 12
Attended Presentation COMPLETED	57 13	52 12
Attended Presentation NOT COMPLETED	55 0	45 0
Post-Presentation Questionnaires STARTED	57 13	52 12
Post-Presentation Questionnaires COMPLETED	49 13	47 12
Post-Presentation Questionnaires NOT COMPLETED	8 0	5 0
3 Month Follow-Up Questionnaires STARTED	57 13	52 12
3 Month Follow-Up Questionnaires COMPLETED	39 13	36 12
3 Month Follow-Up Questionnaires NOT COMPLETED	18 0	16 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 participant chose not to disclose their age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Researcher-Only n=113 Participants The researcher-facilitated presentation, led by two clinical psychology graduate students, will be the same for all schools. 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.	Key Opinion Leader n=97 Participants 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. 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.	Total n=210 Participants Total of all reporting groups
Age, Continuous	40.31 years STANDARD_DEVIATION 7.19 • n=112 Participants • 1 participant chose not to disclose their age	41.06 years STANDARD_DEVIATION 6.29 • n=97 Participants • 1 participant chose not to disclose their age	40.66 years STANDARD_DEVIATION 6.78 • n=209 Participants • 1 participant chose not to disclose their age
Sex: Female, Male Female	104 Participants n=113 Participants • 1 participant chose not to disclose their sex	89 Participants n=96 Participants • 1 participant chose not to disclose their sex	193 Participants n=209 Participants • 1 participant chose not to disclose their sex
Sex: Female, Male Male	9 Participants n=113 Participants • 1 participant chose not to disclose their sex	7 Participants n=96 Participants • 1 participant chose not to disclose their sex	16 Participants n=209 Participants • 1 participant chose not to disclose their sex
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=113 Participants	21 Participants n=97 Participants	33 Participants n=210 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=113 Participants	74 Participants n=97 Participants	173 Participants n=210 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=113 Participants	2 Participants n=97 Participants	4 Participants n=210 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	1 Participants n=97 Participants	1 Participants n=210 Participants
Race (NIH/OMB) Asian	3 Participants n=113 Participants	3 Participants n=97 Participants	6 Participants n=210 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=97 Participants	0 Participants n=210 Participants
Race (NIH/OMB) Black or African American	23 Participants n=113 Participants	16 Participants n=97 Participants	39 Participants n=210 Participants
Race (NIH/OMB) White	80 Participants n=113 Participants	60 Participants n=97 Participants	140 Participants n=210 Participants
Race (NIH/OMB) More than one race	2 Participants n=113 Participants	3 Participants n=97 Participants	5 Participants n=210 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=113 Participants	14 Participants n=97 Participants	19 Participants n=210 Participants

PRIMARY outcome

Timeframe: pre-presentation; post-presentation (within 1 week after the presentation)

Population: The overall number of participants analyzed is greater than the number of participants who completed the pre-presentation questionnaires because some participants completed this measure, but not the entire pre-presentation questionnaire battery. The data reported includes responses from all participants who completed the measure.

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).

Outcome measures

Outcome measures
Measure	Researcher-Only n=114 Participants The researcher-facilitated presentation, led by two clinical psychology graduate students, will be the same for all schools. 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.	Key Opinion Leader n=98 Participants 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. 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.
Change From Pre-Presentation to Post-Presentation in Treatment Seeking Evaluation - Intention to Seek Cognitive Behavioral Therapy Pre-presentation	3.23 score on a scale Standard Deviation 1.18	3.02 score on a scale Standard Deviation 1.22
Change From Pre-Presentation to Post-Presentation in Treatment Seeking Evaluation - Intention to Seek Cognitive Behavioral Therapy Post-presentation	3.67 score on a scale Standard Deviation 1.20	3.79 score on a scale Standard Deviation 1.18

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Researcher-Only n=39 Participants The researcher-facilitated presentation, led by two clinical psychology graduate students, will be the same for all schools. 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.	Key Opinion Leader n=36 Participants 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. 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.
Number of Participants Who Sought Cognitive Behavioral Therapy as Assessed by Treatment Seeking Evaluation - Actual Cognitive Behavioral Therapy Seeking	3 Participants	3 Participants

SECONDARY outcome

Timeframe: pre-presentation; post-presentation (within 1 week after the presentation)

Population: The overall number of participants analyzed is greater than the number of participants who completed the pre-presentation questionnaires because some participants completed this measure, but not the entire pre-presentation questionnaire battery. The data reported includes responses from all participants who completed the measure.

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.

Outcome measures

Outcome measures
Measure	Researcher-Only n=129 Participants The researcher-facilitated presentation, led by two clinical psychology graduate students, will be the same for all schools. 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.	Key Opinion Leader n=109 Participants 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. 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.
Change From Pre-Presentation to Post-Presentation in Parent Engagement in Evidence-Based Services Questionnaire, Knowledge Subscale Post-Presentation	3.56 score on a scale Standard Deviation 0.61	3.70 score on a scale Standard Deviation 0.72
Change From Pre-Presentation to Post-Presentation in Parent Engagement in Evidence-Based Services Questionnaire, Knowledge Subscale Pre-Presentation	3.01 score on a scale Standard Deviation 0.74	3.06 score on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: pre-presentation; post-presentation (within 1 week after the presentation)

Population: The overall number of participants analyzed is greater than the number of participants who completed the pre-presentation questionnaires because some participants completed this measure, but not the entire pre-presentation questionnaire battery. The data reported includes responses from all participants who completed the measure.

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.

Outcome measures

Outcome measures
Measure	Researcher-Only n=124 Participants The researcher-facilitated presentation, led by two clinical psychology graduate students, will be the same for all schools. 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.	Key Opinion Leader n=104 Participants 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. 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.
Change From Pre-Presentation to Post-Presentation in Therapy Subjective Norms Questionnaire Pre-Presentation	32.60 units on a scale Standard Deviation 6.98	31.36 units on a scale Standard Deviation 7.40
Change From Pre-Presentation to Post-Presentation in Therapy Subjective Norms Questionnaire Post-Presentation	34.28 units on a scale Standard Deviation 6.71	33.81 units on a scale Standard Deviation 6.35

SECONDARY outcome

Timeframe: pre-presentation; post-presentation (within 1 week after the presentation)

Population: The number of participants analyzed is greater than the number of participants who completed the pre-presentation questionnaires because some participants completed this measure, but not the entire pre-presentation questionnaire battery. The data reported includes responses from all participants who completed the measure.

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.

Outcome measures

Outcome measures
Measure	Researcher-Only n=114 Participants The researcher-facilitated presentation, led by two clinical psychology graduate students, will be the same for all schools. 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.	Key Opinion Leader n=99 Participants 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. 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.
Change From Pre-Presentation to Post-Presentation in Caregiver Attitudes About Cognitive Behavioral Therapy Pre-Presentation	80.35 units on a scale Standard Deviation 11.94	79.04 units on a scale Standard Deviation 8.63
Change From Pre-Presentation to Post-Presentation in Caregiver Attitudes About Cognitive Behavioral Therapy Post-Presentation	82.98 units on a scale Standard Deviation 8.24	81.13 units on a scale Standard Deviation 7.52

SECONDARY outcome

Timeframe: pre-presentation; post-presentation (within 1 week after the presentation)

Population: The number of participants analyzed is greater than the number of participants who completed the pre-presentation questionnaires because some participants completed this measure, but not the entire pre-presentation questionnaire battery. The data reported includes responses from all participants who completed the measure.

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.

Outcome measures

Outcome measures
Measure	Researcher-Only n=137 Participants The researcher-facilitated presentation, led by two clinical psychology graduate students, will be the same for all schools. 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.	Key Opinion Leader n=112 Participants 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. 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.
Change From Pre-Presentation to Post-Presentation in Parents' Internalized Stigma of Mental Illness Scale Pre-Presentation	15.07 units on a scale Standard Deviation 4.26	15.01 units on a scale Standard Deviation 5.00
Change From Pre-Presentation to Post-Presentation in Parents' Internalized Stigma of Mental Illness Scale Post-Presentation	14.90 units on a scale Standard Deviation 4.30	14.60 units on a scale Standard Deviation 5.90

Adverse Events

Researcher-Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Key Opinion Leader

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margaret Crane

Temple University

Phone: ‭(215) 204-7165‬

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place