The DECIDE Parent-Provider Intervention

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04445155
Collaborator
Smith College (Other)
96
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2
26.9
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Modified DECIDE Parent and Provider Intervention
N/A

Detailed Description

Interventions to optimize parent-provider interactions are urgently needed to ensure adolescents aged 6 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 12-hour workshop and up to 4 individual coaching sessions 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 health care. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Modified DECIDE

DECIDE has two primary components: 1) three parent training sessions designed to help patients effectively ask questions and participate in decisions about care: and 2) a 12-hour workshop and up to 4 individual coaching sessions for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation

Behavioral: Modified DECIDE Parent and Provider Intervention
It will include 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.

No Intervention: Usual Care

Usual Care consists of standard outpatient mental health care, including individual treatment for the adolescent (i.e., therapy, and/or medication) or family treatment for adolescents and parents, delivered in a variety of settings (e.g., clinics, schools, homes).

Outcome Measures

Primary Outcome Measures

  1. Parent Activation Measure Mental Health (P-PAM-MH): baseline [Baseline (TI)]

    13-item scale measures parent activation for use with parents of youth with emotional and behavioral disorders [126]. It was adapted from the original PAM. Items are scored using a 4-point Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw scores are summed and scaled from 0-100. Higher scores indicate greater activation. Cronbach alpha is 0.89. To be completed by Parents. To be completed by both parents and providers.

  2. Parent Activation Measure Mental Health (P-PAM-MH): post-intervention [Immediately post intervention (T2)]

    13-item scale measures parent activation for use with parents of youth with emotional and behavioral disorders [126]. It was adapted from the original PAM. Items are scored using a 4-point Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw scores are summed and scaled from 0-100. Higher scores indicate greater activation. Cronbach alpha is 0.89. To be completed by Parents. To be completed by both parents and providers.

  3. Communication Scale of the Kim Alliance Scale (KAS): baseline [Baseline (T1)]

    12 - item scale measures provider perception of parent-provider communication. Response categories include 1-never to 7 = always. Items are summed with higher scores indicating higher quality of communication. Cronbach alpha is 0.94 [123]. To be completed by both parents and providers. To be completed by both parents and providers.

  4. Communication Scale of the Kim Alliance Scale (KAS): post-intervention [Immediately post intervention (T2)]

    12 - item scale measures provider perception of parent-provider communication. Response categories include 1-never to 7 = always. Items are summed with higher scores indicating higher quality of communication. Cronbach alpha is 0.94 [123]. To be completed by both parents and providers. To be completed by both parents and providers.

  5. Working Alliance Inventory - Short Form: baseline [Baseline (T1)]

    12-item scale assesses parent-provider interactions including therapeutic alliance goals, tasks and bond. Response categories include 1-never to 7 = always. Items are summed with higher scores indicating higher alliance. Cronbach alpha is 0.90 [121; 127]. To be completed both parents and providers. We will also obtain independent rater of the scale using audio tapes. Independent rater will listen to a short (~15minutes) segment first then complete the scale.

  6. Working Alliance Inventory - Short Form: post-intervention [Immediately post intervention (T2)]

    12-item scale assesses parent-provider interactions including therapeutic alliance goals, tasks and bond. Response categories include 1-never to 7 = always. Items are summed with higher scores indicating higher alliance. Cronbach alpha is 0.90 [121; 127]. To be completed both parents and providers. We will also obtain independent rater of the scale using audio tapes. Independent rater will listen to a short (~15minutes) segment first then complete the scale.

  7. Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: baseline [Baseline (T1)]

    5-item scale measures patient's confidence in ability to elicit and understand information from, and communicate information to providers. Provider assessment is 6-item asks providers how confident they think that their patient is in his/her ability to elicit and understand information from, and communicate information to, them (care providers). Response categories are 1 = low to 10 = high. A total score is obtained by summing all individual scores. Cronbach's alpha = 0.83 [124].To be completed by parents.

  8. Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: post-intervention [Immediately post intervention (T2)]

    5-item scale measures patient's confidence in ability to elicit and understand information from, and communicate information to providers. Provider assessment is 6-item asks providers how confident they think that their patient is in his/her ability to elicit and understand information from, and communicate information to, them (care providers). Response categories are 1 = low to 10 = high. A total score is obtained by summing all individual scores. Cronbach's alpha = 0.83 [124].To be completed by parents.

  9. Perception of Care Quality Survey: baseline [Baseline (T1)]

    18-item scale measures parent's perception of care quality. Higher scores indicate perceptions of higher quality of care [125].To be completed by parents.

  10. Perception of Care Quality Survey: post-intervention [Immediately post intervention (T2)]

    18-item scale measures parent's perception of care quality. Higher scores indicate perceptions of higher quality of care [125].To be completed by parents.

  11. Parent Participation Engagement Measure (PPEM): baseline [Baseline (T1)]

    The 5-item scale 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". Higher scores indicate greater frequency of parent engagement. Cronbach alpha = 0.88 [122].

  12. Parent Participation Engagement Measure (PPEM): post-intervention [Immediately post intervention (T2)]

    The 5-item scale 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". Higher scores indicate greater frequency of parent engagement. Cronbach alpha = 0.88 [122].

  13. Parent Engagement in Adolescents' Behavioral Health Care: baseline [Baseline (T1)]

    Defined as proportion visits attended of those scheduled. Obtained from electronic medical record

  14. Parent Engagement in Adolescents' Behavioral Health Care: post-intervention [Immediately post intervention (T2)]

    Defined as proportion visits attended of those scheduled. Obtained from electronic medical record

Secondary Outcome Measures

  1. Adolescent Retention of Behavioral Health Care: baseline [Baseline (T1)]

    Defined as attending at least 4 visits in 6 months period of time. Obtained from electronic medical record

  2. Adolescent Retention of Behavioral Health Care: post-intervention [Immediately post intervention T2]

    Defined as attending at least 4 visits in 6 months period of time. Obtained from electronic medical record

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Providers Inclusion Criteria:
  1. Regular paid staff members who are

  2. Masters-prepared clinical social workers or mental health counselors

  3. Provide behavioral health services to adolescents and their parents at CAP or other site locations.

(We focus on this category of providers because they have primary clinical contact with parents; thus, activation/communication is particularly important for the dyad.)

Parent Inclusion Criteria:
  1. Will have an adolescent with DIC receiving services from a participating CAP/other site location provider.

  2. Must be aged 21 or older

  3. Speak English

  4. Are the biological parent of the adolescent or a parent surrogate serving in a primary caregiver role (for at least past 6 months).

Parent Exclusion Criteria:
  1. If they are a foster parent

  2. If they show significant cognitive impairment or acute emotional distress on screening

  3. If they 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sandra Eskenazi Mental Health Center Indianapolis Indiana United States 46208

Sponsors and Collaborators

  • Indiana University
  • Smith College

Investigators

  • Principal Investigator: Ukamaka M Oruche, PhD, Indiana University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ukamaka Marian Oruche, Associate Professor, Indiana University
ClinicalTrials.gov Identifier:
NCT04445155
Other Study ID Numbers:
  • 1911897011
First Posted:
Jun 24, 2020
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 11, 2022