The DECIDE Parent-Provider Intervention

NCT04445155 | Completed Results

• 2 other identifiers: 19118970115R21MD015150-02
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 5

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.

Conditions

Modified DECIDE Intervention; Treatment as Usual Care Group

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Change in Parent Participation Engagement Measure (PPEM) - Provider and Parent Arm Only

  baseline and immediately post intervention (T2), up to 4 weeks

• 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 Attribution Errors - Provider Arm and Provider Subgroup Arm Only

  baseline and immediately post intervention (T2), up to 4 weeks

• Change in Familiarity With Receptivity - Provider Arm and Provider Subgroup Arm Only

  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

  baseline and immediately post intervention (T2), up to 4 weeks

Study Arms (4)

Modified DECIDE-Provider Arm

EXPERIMENTAL

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

Behavioral: Modified DECIDE Parent and Provider Intervention

Modified DECIDE-Parent Arm

EXPERIMENTAL

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

Behavioral: Modified DECIDE Parent and Provider Intervention

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.

Behavioral: Modified DECIDE Parent and Provider Intervention

Treatment as Usual

NO INTERVENTION

Control arm

Interventions

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.

Modified DECIDE-Parent Arm; Modified DECIDE-Provider Arm; Provider Subgroup Study

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• Associate's or bachelor's or PhD prepared providers who work with parents OR
• Masters-prepared clinical social workers or mental health counselors and
• Provide behavioral health services to adolescents and their parents. OR
• Doctoral level interns (e.g. in psychology) and
• Provide behavioral health services to adolescents and their parents OR
• 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.
• are aged 21 or older
• speak English
• 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, ).
• 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).
• Attends regular appointments with a provider
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Smith College: collaborator
• University of South Florida: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (5)

Centerstone

Sarasota, Florida, 34233, United States

Location

Centerstone

Bloomington, Indiana, 47404, United States

Location

Bowen Center

Fort Wayne, Indiana, 46808, United States

Location

Sandra Eskenazi Mental Health Center

Indianapolis, Indiana, 46208, United States

Location

Centerstone

Nashville, Tennessee, 37204, United States

Location

Results Point of Contact

• Title: Dr. Ukamaka Oruche
• Organization: University of South Florida

orucheu@usf.edu

813-396-2524

Study Officials

• Ukamaka M Oruche, PhD

  IU Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Director

Model Details: For clarity, each intervention group was separate and not comparable to other intervention groups.

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: June 24, 2020
• Study Start: October 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 28, 2024
• Results First Posted: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)