The DECIDE Parent-Provider Intervention

NCT ID: NCT04445155

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-12-30

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.

Conditions

Modified DECIDE Intervention; Treatment as Usual Care Group

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified DECIDE-Provider Arm

2-4 hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation.

Group Type: EXPERIMENTAL

Modified DECIDE Parent and Provider Intervention

Intervention Type: 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.

Modified DECIDE-Parent Arm

Up to three parent training sessions designed to help patients effectively ask questions and participate in decisions about care.

Group Type: EXPERIMENTAL

Modified DECIDE Parent and Provider Intervention

Intervention Type: 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.

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.

Group Type: OTHER

Modified DECIDE Parent and Provider Intervention

Intervention Type: 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.

Treatment as Usual

Control arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.)

Phase II, Aims 2 and 3.

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.

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

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Smith College

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Ukamaka Marian Oruche

Project Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ukamaka M Oruche, PhD

Role: PRINCIPAL_INVESTIGATOR

IU Nursing

Locations

Centerstone

Sarasota, Florida, United States

Centerstone

Bloomington, Indiana, United States

Bowen Center

Fort Wayne, Indiana, United States

Sandra Eskenazi Mental Health Center

Indianapolis, Indiana, United States

Centerstone

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R21MD015150-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1911897011

Identifier Type: -

Identifier Source: org_study_id