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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21MD015150-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Smith College | OTHER |
| University of South Florida | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) |
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The DECIDE Parent-Provider Intervention is designed to support parents caring for adolescents who are receiving treatment for Disruptive, Impulse-Control, and Conduct disorders. Participating in DECIDE study may help you effectively ask questions and participate in decisions about your adolescent's care. There were three active study arms, each arm had a pre-post design of the DECIDE modified intervention.
Interventions to optimize parent-provider interactions are urgently needed to ensure adolescents aged 3 to 17 years with Disruptive, Impulse-Control, and Conduct disorders (DIC) receive the behavioral health care they need. For these adolescents, behavioral health care is complex, long-term, and requires parental participation. Research shows providers have biases and limited skills and confidence to communicate with these parents to encourage them to voice their concerns and care preferences. Low income and minority parents are at greatest risk of not being involved in their adolescents' behavioral health care, having poor interactions with providers, and are more likely to perceive poor quality of their adolescents' behavioral health care, and low treatment engagement. If unaddressed, poor parent-provider interactions interfere with adolescents' retention in behavioral health care.
No evidence-based interventions have targeted both parents and providers to optimize their interactions and improve behavioral health care for adolescents with DIC. To address these problems, the investigators propose modifying the evidence-based DECIDE intervention to target parents and providers of adolescents with DIC. DECIDE stands for Decide the problem; Explore the questions; Closed or open-ended questions; Identify the who, why, or how of the problem; Direct questions to your health care professional; Enjoy a shared solution. DECIDE was developed for ethnically/racially diverse adult patients with serious mental illness and the latest evidence-based iterations include intervention components targeted to and shown to increase patient activation, provider communication, and patient-provider interactions.
DECIDE has two primary components: 1) three patient training sessions designed to help patients effectively ask questions and participate in decisions about their care: and 2) a 4-hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation and collaboration. The purposes of this two-phase study are: Phase I, Aim 1.
Modify the DECIDE intervention for parents and providers of adolescents with DIC. Phase II, Aim 2. Evaluate the feasibility and acceptability of modified DECIDE. Aim 3. Estimate preliminary effects of modified DECIDE to improve parent, provider, and adolescent outcomes.
Innovative features of this study are the proposed focus on both parents and providers; and inclusion of parent activation and provider communication, which are new in field of child and adolescent behavioral health care, and focus on low income and minority parents. The investigators expect to find that compared to usual care: Hypothesis 3.1. Modified DECIDE parents will show greater improvements in: 1) activation; 2) parent-provider interactions; 3) perceived management of adolescents' behavioral health care, 4) perceived quality of adolescents' behavioral health care, and 5) engagement in adolescents' behavioral healthcare. Hypothesis 3.2. Modified DECIDE providers will show greater improvements in: 1) communication skills; and 2) parent-provider interactions. Hypothesis 3.3. Adolescents of modified DECIDE parents and providers will show higher rates of retention in behavioral health care. Sample will include 16 providers and their parents ( ~ 5 parents per provider, n= 80) recruited from the Child and Adolescents Program of a large safety net health system setting that serves predominately low income and minority persons. Feasibility will be assessed using tracking logs and field notes, and acceptability through parent and provider satisfaction scores and in depth, semi structured interviews. Outcomes will be assessed at baseline and within 4 weeks post- intervention using standardized questionnaires or surveys from parents, providers, and independent observers reports. Effects sizes will be estimated using linear mixed models. If study findings are positive, we will be poised to test the modified DECIDE intervention in a fully powered R01 level randomized, controlled, multi-site clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified DECIDE-Provider Arm | Experimental | 2-4 hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation. |
|
| Modified DECIDE-Parent Arm | Experimental | Up to three parent training sessions designed to help patients effectively ask questions and participate in decisions about care. |
|
| Provider Subgroup Study | Other | To boost provider recruitment, we sought recommendations from a subgroup of providers. We gave each provider access to the DECIDE online training and the pre- and post-survey. |
|
| Treatment as Usual | No Intervention | Control arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified DECIDE Parent and Provider Intervention | Behavioral | The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Parent Needs & Resources Domain of CANS - Provider Arm Only | Change in Parent Needs & Resources Domain of CANS is measured using three items from the Parent Needs & Resources Domain of the Child and Adolescent Needs and Strengths (CANS), Involvement with Care, Knowledge, and Organization. Each item is scored 0, 1, 2, or 3. A domain score is created by calculating the sum of the items. The domain score ranges from 0 to 9 with higher scores meaning more need/less strength and is calculated at baseline and immediately post-intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -9 to 9 with positive values indicating in increase in need/decrease in strength. | baseline and immediately post intervention (T2), up to 4 weeks |
| Change in Parent Activation Measure Mental Health (P-PAM-MH) - Parent Arm Only | Change in Parent Activation Measure Mental Health is measured using a 13-item scale. Items are scored using a 4-point Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw item scores are summed and scaled from 0-100. Higher scores indicate greater activation and is calculated at baseline and immediately post-intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -100 to 100 with positive values indicating an increase in activation. | baseline and immediately post intervention (T2), up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Parent Participation Engagement Measure (PPEM) - Provider and Parent Arm Only | Change in Parent Participation Engagement Measure is measured using a 5-item scale that measures the frequency with which the parent engaged during clinical encounter or parent-provider interaction. Behaviors assessed include asking questions, making suggestions or sharing one's opinion or point of view, and participating in therapeutic activities. Response options are on a 5-point scale ranging from 1 = "not at all" to 5 = "very much". A mean score is calculated using all 5 items and has a range of 1 to 5. Higher scores indicate greater frequency of parent engagement and is calculated at baseline and immediately post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -4 to 4 with positive values indicating an increase in activation. |
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Phase 1, Aim 1.
Inclusion Criteria (for Parent Advisory Board; to assist with intervention development):
1. Parents of adolescents with DIC, who are receiving services at Midtown Child and Adolescent Program or CAP. (We will invite parents 1) from our previous study advisory board (n=3), and two who participated in preliminary study 2 that agreed to be contacted for future studies.)
Inclusion Criteria (for Provider Advisory Board; to assist with intervention development):
1. CAP staffs who do not meet the inclusion criteria in phase 2 (i.e. manager and clinical coordinators or supervisors, clinic nurse, advanced practice registered nurses, or psychiatrists). (We will invite two other direct care providers who work in the healthcare system but not at recruitment site. No providers or parents will be excluded on basis of race/ethnicity, gender, or sexual orientation.)
Phase II, Aims 2 and 3.
Inclusion Criteria:
Inclusion Criteria for providers and interns: Providers will be regular paid staff members who are:
(1) be currently working with a center or private practice to complete requirements for their Master's degree and (2) be providing behavioral health services to adolescents and their parents.
Inclusion Criteria for Guardians: Guardians will have a child or adolescent with DIC receiving services from a participating mental health provider. Parents/guardians meeting all the following criteria are eligible:
Exclusion Criteria for parents:
No providers or parents will be excluded on basis of race/ethnicity, gender, or sexual orientation.
Specifically for semi-structured interview post intervention. Include: All intervention providers (n = 8) and two of each of their parents (n = 16). To explore different levels of acceptability by parents, for each provider, one parent will be chosen who has a high score (> 3) on the CSQ and one parent who has a low score (< 3). Both parents and providers will be asked about their experience with the intervention, what was helpful or not, and how they would change the intervention.
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| Name | Affiliation | Role |
|---|---|---|
| Ukamaka M Oruche, PhD | IU Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centerstone | Sarasota | Florida | 34233 | United States | ||
| Centerstone |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39377512 | Derived | Oruche UM, Holladay CM, Chacko A, Nakash O, Draucker CB. Development and Acceptability of Provider Training to Increase Treatment Engagement of Parents in Their Children's Behavioral Health Care Need. J Am Psychiatr Nurses Assoc. 2024 Nov-Dec;30(6):927-939. doi: 10.1177/10783903241284014. Epub 2024 Oct 8. | |
| 38668829 | Derived | Oruche UM, Nakash O, Holladay C, Chacko A, Perkins SM, Draucker CB. Implementation of Research in Community Mental Health Centers: The Challenge of Provider Engagement. Community Ment Health J. 2024 Oct;60(7):1247-1254. doi: 10.1007/s10597-024-01282-7. Epub 2024 Apr 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified DECIDE-Provider Arm | 2-4 hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. |
| FG001 | Modified DECIDE-Parent Arm | Up to three parent training sessions designed to help patients effectively ask questions and participate in decisions about care. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. |
| FG002 | Provider Subgroup Study | To boost provider recruitment, we sought recommendations from a subgroup of providers. We gave each provider access to the DECIDE online training and the pre- and post-survey. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. |
| FG003 | Treatment as Usual | Control arm: Usual Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
There were no participants enrolled in the Treatment as Usual (Control) Arm. For the Provider Arm, we are only including demographics for those that completed at least one baseline or post-test outcome measure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified DECIDE-Provider Arm | 2-4 hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | For Provider Arm, two participants did not report their age. For Parent Arm, two participants did not report their age. Age was not collected for the Provider Subgroup Arm. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Parent Needs & Resources Domain of CANS - Provider Arm Only | Change in Parent Needs & Resources Domain of CANS is measured using three items from the Parent Needs & Resources Domain of the Child and Adolescent Needs and Strengths (CANS), Involvement with Care, Knowledge, and Organization. Each item is scored 0, 1, 2, or 3. A domain score is created by calculating the sum of the items. The domain score ranges from 0 to 9 with higher scores meaning more need/less strength and is calculated at baseline and immediately post-intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -9 to 9 with positive values indicating in increase in need/decrease in strength. | In the Provider Arm, 34 participants completed both baseline and immediately post-intervention timepoints. This scale was not collected in the other study arms. | Posted | Median | Inter-Quartile Range | units on a scale | baseline and immediately post intervention (T2), up to 4 weeks |
|
4 months from baseline
89 participants at risk for Serious Adverse Events 89 participants at risk for All-Cause Mortality 89 participants at risk for Other (not Including Serious)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified DECIDE-Provider Arm | 2-4 hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ukamaka Oruche | University of South Florida | 813-396-2524 | orucheu@usf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2022 | Jan 15, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2023 | Jan 15, 2024 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 6, 2022 | Jan 15, 2024 | ICF_004.pdf |
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| NIH |
For clarity, each intervention group was separate and not comparable to other intervention groups.
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| baseline and immediately post intervention (T2), up to 4 weeks |
| Change in Familiarity With Perspective Taking - Provider Arm and Provider Subgroup Arm Only | Change in familiarity with perspective taking is measured using a single item that measures familiarity with concept of perspective taking. The response options are 0=Not at all, 1=A little bit, and 2=A lot. A higher score means more familiarity with the concept of perspective taking and is calculated at baseline and post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -2 to 2 with positive values indicating an increase in familiarity with the concept of perspective taking. | baseline and immediately post intervention (T2), up to 4 weeks |
| Change in Familiarity With Attribution Errors - Provider Arm and Provider Subgroup Arm Only | Change in familiarity with attribution errors is measured using a single item that measures familiarity with concept of attribution errors. The response options are 1=Not at all, 2=A little bit, and 3=A lot. A higher score means more familiarity with the concept of attribution errors and is calculated at baseline and post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -2 to 2 with positive values indicating an increase in familiarity with the concept of attribution errors. | baseline and immediately post intervention (T2), up to 4 weeks |
| Change in Familiarity With Receptivity - Provider Arm and Provider Subgroup Arm Only | Change in familiarity with receptivity is measured using a single item that measures familiarity with concept of receptivity. The response options are 1=Not at all, 2=A little bit, and 3=A lot. A higher score means more familiarity with the concept of receptivity and is calculated at baseline and post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -2 to 2 with positive values indicating an increase in familiarity with the concept of receptivity. | baseline and immediately post intervention (T2), up to 4 weeks |
| Change in Communication Scale of the Kim Alliance Scale Refined (KAS-R): Post-intervention - Parent Arm Only | Change in the Communication scale of the Kim Alliance Scale Refined is measured using a 4-item scale that measures perception of parent-provider communication. Response categories include 1 = never to 4 = always. Items are summed with higher scores indicating higher quality of communication and is calculated at baseline and post intervention (range 4 to 16). Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -12 to 12 with positive values indicating an increase in quality of communication. | baseline and immediately post intervention (T2), up to 4 weeks |
| Change in Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: Post-intervention - Parent Arm Only | Change in Perceived Efficacy in Parent-Physician Interactions is measured using a 10-item scale that measures patient's confidence in ability to elicit and understand information from and communicate information to providers. Response categories are 1 = low to 10 = high. A total score is obtained by summing all individual scores with higher scores indicating greater perceived confidence in ability to elicit and understand information from and communicate information to providers (range = 10 to 100). Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -90 to 90 with positive values indicating an increase confidence in ability to elicit and understand information from and communicate information to providers. | baseline and immediately post intervention (T2), up to 4 weeks |
| Change in Perception of Care Quality Survey: Post-intervention - Parent Only | Change in Perception of Care Quality is measured using a single item that measures overall rating of parent's perception of care quality. Reponses are 1 to 10 where 1=Worst possible care to 10=Best possible care. Higher scores indicate perceptions of higher quality of care. Item was collected at baseline and immediately post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -9 to 9 with positive values indicating an increase in rating of perception of higher quality of care. | baseline and immediately post intervention (T2), up to 4 weeks |
| Bloomington |
| Indiana |
| 47404 |
| United States |
| Bowen Center | Fort Wayne | Indiana | 46808 | United States |
| Sandra Eskenazi Mental Health Center | Indianapolis | Indiana | 46208 | United States |
| Centerstone | Nashville | Tennessee | 37204 | United States |
| Withdrawal by Subject |
|
| Unable to recruit parent participants so unable to begin study as initially designed |
|
| Only completed a portion of the final outcome measures (T2) |
|
| BG001 | Modified DECIDE-Parent Arm | Up to three parent training sessions designed to help patients effectively ask questions and participate in decisions about care. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. |
| BG002 | Provider Subgroup Study | To boost provider recruitment, we sought recommendations from a subgroup of providers. We gave each provider access to the DECIDE online training and the pre- and post-survey. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. |
| BG003 | Treatment as Usual | Control arm: Usual Care |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | For the Provider Arm, two participants did not report their age. For Parent Arm, two participants did not report their age. Age was not collected for the Provider Subgroup Arm. | Median | Full Range | years |
|
| Sex: Female, Male | For the Provider Arm, 2 participants did not report sex. Sex was not collected for the Provider Subgroup Arm. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity was not collected for the Provider Subgroup Arm. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race was not collected for the Provider Subgroup Arm. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Parent Needs & Resources Domain of CANS - Provider Arm Only | Parent Needs & Resources Domain of CANS is measured using three items from the Parent Needs & Resources Domain of the Child and Adolescent Needs and Strengths (CANS), Involvement with Care, Knowledge, and Organization. Each item is scored 0, 1, 2, or 3. A domain score is created by calculating the sum of the items. The domain score ranges from 0 to 9 with higher scores meaning more need/less strength. | In the Provider Arm, one participant did not complete this scale at baseline. This scale was not collected in the other study arms. | Median | Inter-Quartile Range | units on a scale |
|
| Parent Activation Measure Mental Health (P-PAM-MH) - Parent Arm Only | Parent Activation Measure Mental Health is measured using a 13-item scale. Items are scored using a 4-point Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw item scores are summed and scaled from 0-100. Higher scores indicate greater activation. | This scale was only collected in the Parent Arm. | Median | Inter-Quartile Range | units on a scale |
|
| Parent Participation Engagement Measure (PPEM) - Provider and Parent Arm Only | Parent Participation Engagement Measure is measured using a 5-item scale that measures the frequency with which the parent engaged during clinical encounter or parent-provider interaction. Behaviors assessed include asking questions, making suggestions or sharing one's opinion or point of view, and participating in therapeutic activities. Response options are on a 5-point scale ranging from 1 = "not at all" to 5 = "very much". A mean score is calculated using all 5 items and has a range of 1 to 5. Higher scores indicate greater frequency of parent engagement. | In the Provider Arm, one participant did not complete this scale at baseline. This scale was only collected in the Provider Arm and Parent Arm. | Mean | Standard Deviation | units on a scale |
|
| Familiarity with Perspective Taking - Provider Arm and Provider Subgroup Arm Only | Familiarity with perspective taking is measured using a single item that measures familiarity with concept of perspective taking. The response options are 0=Not at all, 1=A little bit, and 2=A lot. A higher score means more familiarity with the concept of perspective taking. | In the Provider Arm, one participant did not complete this scale at baseline. This scale was only collected in the Provider Arm and Provider Subgroup Arm. | Count of Participants | Participants |
|
| Familiarity with Attribution Errors - Provider Arm and Provider Subgroup Arm Only | Familiarity with attribution errors is measured using a single item that measures familiarity with concept of attribution errors. The response options are 1=Not at all, 2=A little bit, and 3=A lot. A higher score means more familiarity with the concept of attribution errors. | In the Provider Arm, one participant did not complete this scale at baseline. This scale was only collected in the Provider Arm and Provider Subgroup Arm. | Count of Participants | Participants |
|
| Familiarity with Receptivity - Provider Arm and Provider Subgroup Arm Only | Familiarity with receptivity is measured using a single item that measures familiarity with concept of receptivity. The response options are 1=Not at all, 2=A little bit, and 3=A lot. A higher score means more familiarity with the concept of receptivity. | In the Provider Arm, two participants did not complete this scale at baseline. This scale was only collected in the Provider Arm and Provider Subgroup Arm. | Count of Participants | Participants |
|
| Communication Scale of the Kim Alliance Scale Refined (KAS-R) - Parent Arm Only | Communication scale of the Kim Alliance Scale Refined is measured using a 4-item scale that measures perception of parent-provider communication. Response categories include 1 = never to 4 = always. Items are summed with higher scores indicating higher quality of communication (range = 4 to 16). | This scale was only collected in the Parent Arm. | Median | Inter-Quartile Range | units on a scale |
|
| Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form - Parent Arm Only | Perceived Efficacy in Parent-Physician Interactions is measured using a 10-item scale that measures patient's confidence in ability to elicit and understand information from and communicate information to providers. Response categories are 1 = low to 10 = high. A total score is obtained by summing all individual scores with higher scores indicating greater perceived confidence in ability to elicit and understand information from and communicate information to providers (range = 10 to 100). | This scale was only collected in the Parent Arm. | Median | Inter-Quartile Range | units on a scale |
|
| Perception of Care Quality Survey - Parent Arm Only | Perception of Care Quality is measured using a single item that measures overall rating of parent's perception of care quality. Reponses are 1 to 10 where 1=Worst possible care to 10=Best possible care. Higher scores indicate perceptions of higher quality of care. | This item was only collected in the Parent Arm. | Median | Inter-Quartile Range | units on a scale |
|
| Modified DECIDE-Provider Arm |
2-4 hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. |
| OG001 | Modified DECIDE-Parent Arm | Up to three parent training sessions designed to help patients effectively ask questions and participate in decisions about care. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. |
| OG002 | Provider Subgroup Study | To boost provider recruitment, we sought recommendations from a subgroup of providers. We gave each provider access to the DECIDE online training and the pre- and post-survey. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. |
| OG003 | Treatment as Usual | Control arm: Usual Care |
|
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| Primary | Change in Parent Activation Measure Mental Health (P-PAM-MH) - Parent Arm Only | Change in Parent Activation Measure Mental Health is measured using a 13-item scale. Items are scored using a 4-point Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw item scores are summed and scaled from 0-100. Higher scores indicate greater activation and is calculated at baseline and immediately post-intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -100 to 100 with positive values indicating an increase in activation. | In the Parent Arm, 4 participants completed both baseline and immediately post-intervention timepoints. This scale was not collected in the other study arms. | Posted | Median | Inter-Quartile Range | units on a scale | baseline and immediately post intervention (T2), up to 4 weeks |
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| Secondary | Change in Parent Participation Engagement Measure (PPEM) - Provider and Parent Arm Only | Change in Parent Participation Engagement Measure is measured using a 5-item scale that measures the frequency with which the parent engaged during clinical encounter or parent-provider interaction. Behaviors assessed include asking questions, making suggestions or sharing one's opinion or point of view, and participating in therapeutic activities. Response options are on a 5-point scale ranging from 1 = "not at all" to 5 = "very much". A mean score is calculated using all 5 items and has a range of 1 to 5. Higher scores indicate greater frequency of parent engagement and is calculated at baseline and immediately post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -4 to 4 with positive values indicating an increase in activation. | In the Provider Arm, 34 participants completed both baseline and immediately post-intervention timepoints. In the Parent Arm, 4 participants completed both baseline and immediately post-intervention timepoints. This scale was not collected in the other study arms. | Posted | Mean | Standard Deviation | units on a scale | baseline and immediately post intervention (T2), up to 4 weeks |
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| Secondary | Change in Familiarity With Perspective Taking - Provider Arm and Provider Subgroup Arm Only | Change in familiarity with perspective taking is measured using a single item that measures familiarity with concept of perspective taking. The response options are 0=Not at all, 1=A little bit, and 2=A lot. A higher score means more familiarity with the concept of perspective taking and is calculated at baseline and post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -2 to 2 with positive values indicating an increase in familiarity with the concept of perspective taking. | In the Provider Arm, 35 participants completed both baseline and immediately post-intervention timepoints. In the Provider Subgroup Arm, 13 completed both baseline and immediately post-intervention timepoints. This scale was only collected in the Provider Arm and Provider Subgroup Arm. | Posted | Median | Inter-Quartile Range | units on a scale | baseline and immediately post intervention (T2), up to 4 weeks |
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| Secondary | Change in Familiarity With Attribution Errors - Provider Arm and Provider Subgroup Arm Only | Change in familiarity with attribution errors is measured using a single item that measures familiarity with concept of attribution errors. The response options are 1=Not at all, 2=A little bit, and 3=A lot. A higher score means more familiarity with the concept of attribution errors and is calculated at baseline and post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -2 to 2 with positive values indicating an increase in familiarity with the concept of attribution errors. | In the Provider Arm, 35 participants completed both baseline and immediately post-intervention timepoints. In the Provider Subgroup Arm, 13 completed both baseline and immediately post-intervention timepoints. This scale was was only collected in the Provider Arm and Provider Subgroup Arm. | Posted | Median | Inter-Quartile Range | units on a scale | baseline and immediately post intervention (T2), up to 4 weeks |
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| Secondary | Change in Familiarity With Receptivity - Provider Arm and Provider Subgroup Arm Only | Change in familiarity with receptivity is measured using a single item that measures familiarity with concept of receptivity. The response options are 1=Not at all, 2=A little bit, and 3=A lot. A higher score means more familiarity with the concept of receptivity and is calculated at baseline and post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -2 to 2 with positive values indicating an increase in familiarity with the concept of receptivity. | In the Provider Arm, 34 participants completed both baseline and immediately post-intervention timepoints. In the Provider Subgroup Arm, 13 completed both baseline and immediately post-intervention timepoints. This scale was only collected in the Provider Arm and Provider Subgroup Arm. | Posted | Median | Inter-Quartile Range | units on a scale | baseline and immediately post intervention (T2), up to 4 weeks |
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| Secondary | Change in Communication Scale of the Kim Alliance Scale Refined (KAS-R): Post-intervention - Parent Arm Only | Change in the Communication scale of the Kim Alliance Scale Refined is measured using a 4-item scale that measures perception of parent-provider communication. Response categories include 1 = never to 4 = always. Items are summed with higher scores indicating higher quality of communication and is calculated at baseline and post intervention (range 4 to 16). Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -12 to 12 with positive values indicating an increase in quality of communication. | In the Parent Arm, 3 participants completed both baseline and immediately post-intervention timepoints. This scale was not collected in the other study arms. | Posted | Median | Inter-Quartile Range | units on a scale | baseline and immediately post intervention (T2), up to 4 weeks |
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| Secondary | Change in Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: Post-intervention - Parent Arm Only | Change in Perceived Efficacy in Parent-Physician Interactions is measured using a 10-item scale that measures patient's confidence in ability to elicit and understand information from and communicate information to providers. Response categories are 1 = low to 10 = high. A total score is obtained by summing all individual scores with higher scores indicating greater perceived confidence in ability to elicit and understand information from and communicate information to providers (range = 10 to 100). Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -90 to 90 with positive values indicating an increase confidence in ability to elicit and understand information from and communicate information to providers. | In the Parent Arm, 3 participants completed both baseline and immediately post-intervention timepoints. This scale was only collected in the Parent Arm. | Posted | Median | Inter-Quartile Range | units on a scale | baseline and immediately post intervention (T2), up to 4 weeks |
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| Secondary | Change in Perception of Care Quality Survey: Post-intervention - Parent Only | Change in Perception of Care Quality is measured using a single item that measures overall rating of parent's perception of care quality. Reponses are 1 to 10 where 1=Worst possible care to 10=Best possible care. Higher scores indicate perceptions of higher quality of care. Item was collected at baseline and immediately post intervention. Change from baseline equals the score immediately post-intervention minus the score at baseline. Changes can range from -9 to 9 with positive values indicating an increase in rating of perception of higher quality of care. | In the Parent Arm, 3 participants completed both baseline and immediately post-intervention timepoints. This item was only collected in the Parent Arm. | Posted | Median | Inter-Quartile Range | units on a scale | baseline and immediately post intervention (T2), up to 4 weeks |
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| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | Modified DECIDE-Parent Arm | Up to three parent training sessions designed to help patients effectively ask questions and participate in decisions about care. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Provider Subgroup Study | To boost provider recruitment, we sought recommendations from a subgroup of providers. We gave each provider access to the DECIDE online training and the pre- and post-survey. Modified DECIDE Parent and Provider Intervention: The parent component will include up to three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | Treatment as Usual | Control arm: Usual Care | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| >=65 years |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 3 = A lot |
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| 3 = A lot |
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| 3 = A lot |
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| Wilcoxon Signed-Rank test |
| 0.008 |
| Superiority |
| Wilcoxon Signed-Rank test |
| 0.002 |
| Superiority |
| Wilcoxon Signed-Rank test |
| 0.125 |
| Superiority |