Clinical trial NCT04445155: The DECIDE Parent-Provider Intervention
Official title: Modification and Evaluation of the DECIDE Intervention to Improve Parent-provider Interactions in Low-income Parents of Adolescents With Disruptive Impulse Control, and Conduct Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Modified DECIDE Intervention
Treatment as Usual Care Group
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Smith College
name: University of South Florida
name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-06-24
Enrollment: 89
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: For clarity, each intervention group was separate and not comparable to other intervention groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. 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.

Primary outcomes:
measure: Change in Parent Needs & Resources Domain of CANS - Provider Arm Only
timeFrame: baseline and immediately post intervention (T2), up to 4 weeks
measure: Change in Parent Activation Measure Mental Health (P-PAM-MH) - Parent Arm Only
timeFrame: baseline and immediately post intervention (T2), up to 4 weeks
Secondary outcomes:
measure: Change in Parent Participation Engagement Measure (PPEM) - Provider and Parent Arm Only
timeFrame: baseline and immediately post intervention (T2), up to 4 weeks
measure: Change in Familiarity With Perspective Taking - Provider Arm and Provider Subgroup Arm Only
timeFrame: baseline and immediately post intervention (T2), up to 4 weeks
measure: Change in Familiarity With Attribution Errors - Provider Arm and Provider Subgroup Arm Only
timeFrame: baseline and immediately post intervention (T2), up to 4 weeks
measure: Change in Familiarity With Receptivity - Provider Arm and Provider Subgroup Arm Only
timeFrame: baseline and immediately post intervention (T2), up to 4 weeks
measure: Change in Communication Scale of the Kim Alliance Scale Refined (KAS-R): Post-intervention - Parent Arm Only
timeFrame: baseline and immediately post intervention (T2), up to 4 weeks
measure: Change in Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: Post-intervention - Parent Arm Only
timeFrame: baseline and immediately post intervention (T2), up to 4 weeks
measure: Change in Perception of Care Quality Survey: Post-intervention - Parent Only
timeFrame: baseline and immediately post intervention (T2), up to 4 weeks
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Centerstone
state: Florida
city: Bloomington
country: United States
facility: Centerstone
state: Indiana
city: Fort Wayne
country: United States
facility: Bowen Center
state: Indiana
city: Indianapolis
country: United States
facility: Sandra Eskenazi Mental Health Center
state: Indiana
city: Nashville
country: United States
facility: Centerstone
state: Tennessee
Study officials:
affiliation: IU Nursing
name: Ukamaka M Oruche, PhD
role: PRINCIPAL_INVESTIGATOR
References: