The DECIDE Parent-Provider Intervention

Not Applicable

Completed

• Conditions: Modified DECIDE Intervention; Treatment as Usual Care Group
• Interventions: Behavioral: Modified DECIDE Parent and Provider Intervention

• Registration Number: NCT04445155
• Lead Sponsor: Indiana University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2020-10-01
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Results First Submitted: 2023-12-18
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-27
• Last Update Submitted: 2024-03-27
• Results First Posted: 2024-03-28
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Inclusion Criteria for providers and interns: Providers will be regular paid staff members who are:

1. Associate's or bachelor's or PhD prepared providers who work with parents OR
2. Masters-prepared clinical social workers or mental health counselors and
3. Provide behavioral health services to adolescents and their parents. OR
4. Doctoral level interns (e.g. in psychology) and
5. Provide behavioral health services to adolescents and their parents OR
6. Providers who are bachelor's prepared interns must:

(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:

1. are aged 21 or older
2. speak English
3. are the guardian (biological parent, adoptive parent, step parent, foster parent, or legal guardian) of the child or adolescent or a parent surrogate serving in a primary caregiver role (referred to as "parents"; if foster parent or legal guardian, ).
4. must have a child or adolescent aged 3 to 17 years with a diagnosis of Disruptive Impulse Control and Conduct Disorder (DIC) by a mental health professional. (This includes children with behavior problems, such as Oppositional Defiant disorder, Conduct disorders, or Intermittent Explosive disorders).
5. Attends regular appointments with a provider
6. Foster parents will be included if they have a child with DIC now or in the past, and regardless of whether that child is receiving services from a participating mental health provider or not.

Exclusion Criteria for parents:

• Show significant cognitive impairment or acute emotional distress on screening
• Have an incarcerated adolescent

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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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified DECIDE-Provider Arm	Modified DECIDE Parent and Provider Intervention	2-4 hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation.
Provider Subgroup Study	Modified DECIDE Parent and Provider Intervention	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 Arm	Modified DECIDE Parent and Provider Intervention	Up to three parent training sessions designed to help patients effectively ask questions and participate in decisions about care.

Primary Outcome Measures

Name	Time	Method
Change in Parent Needs & Resources Domain of CANS - Provider Arm Only	baseline and immediately post intervention (T2), up to 4 weeks	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.
Change in Parent Activation Measure Mental Health (P-PAM-MH) - Parent Arm Only	baseline and immediately post intervention (T2), up to 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Communication Scale of the Kim Alliance Scale Refined (KAS-R): Post-intervention - Parent Arm Only	baseline and immediately post intervention (T2), up to 4 weeks	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.
Change in Perception of Care Quality Survey: Post-intervention - Parent Only	baseline and immediately post intervention (T2), up to 4 weeks	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.
Change in Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: Post-intervention - Parent Arm Only	baseline and immediately post intervention (T2), up to 4 weeks	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.
Change in Familiarity With Perspective Taking - Provider Arm and Provider Subgroup Arm Only	baseline and immediately post intervention (T2), up to 4 weeks	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.
Change in Familiarity With Attribution Errors - Provider Arm and Provider Subgroup Arm Only	baseline and immediately post intervention (T2), up to 4 weeks	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.
Change in Familiarity With Receptivity - Provider Arm and Provider Subgroup Arm Only	baseline and immediately post intervention (T2), up to 4 weeks	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.
Change in Parent Participation Engagement Measure (PPEM) - Provider and Parent Arm Only	baseline and immediately post intervention (T2), up to 4 weeks	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.

Trial Locations

Locations (3)

Bowen Center; 🇺🇸 Fort Wayne, Indiana, United States

Sandra Eskenazi Mental Health Center; 🇺🇸 Indianapolis, Indiana, United States

Centerstone; 🇺🇸 Nashville, Tennessee, United States