Modified DECIDE InterventionNCT04445155
The DECIDE Parent-Provider Intervention
A study testing Modified DECIDE Parent and Provider Intervention in people with Modified DECIDE Intervention and Treatment as Usual Care Group, run by Indiana University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Modified DECIDE Intervention, Treatment as Usual Care Group
- What is being tested?
- Modified DECIDE Parent and Provider Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion Criteria for providers and interns: Providers will be regular paid staff members who are:
- 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
Show all 15Show fewer
- Providers who are bachelor's prepared interns must:
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Centerstone
Bloomington, Indiana, 47404
Bowen Center
Fort Wayne, Indiana, 46808
Sandra Eskenazi Mental Health Center
Indianapolis, Indiana, 46208
Centerstone
Nashville, Tennessee, 37204
Centerstone
Sarasota, Florida, 34233
About this study
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
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.
Read the 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.
- Being tested
- Modified DECIDE Parent and Provider Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified DECIDE Parent and Provider InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Modified DECIDE-Provider Arm | Experimental | 2-4 hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation. Receives: 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. Receives: 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. Receives: Behavioral: Modified DECIDE Parent and Provider Intervention |
| Treatment as Usual | No intervention | Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: baseline and immediately post intervention (T2), up to 4 weeks
Change in Familiarity With Perspective Taking - Provider Arm and Provider Subgroup Arm Only
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.
Measured: baseline and immediately post intervention (T2), up to 4 weeks
Change in Familiarity With Attribution Errors - Provider Arm and Provider Subgroup Arm Only
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.
Measured: baseline and immediately post intervention (T2), up to 4 weeks
Change in Familiarity With Receptivity - Provider Arm and Provider Subgroup Arm Only
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.
Measured: 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
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.
Measured: baseline and immediately post intervention (T2), up to 4 weeks
Change in Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: Post-intervention - Parent Arm Only
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.
Measured: baseline and immediately post intervention (T2), up to 4 weeks
Change in Perception of Care Quality Survey: Post-intervention - Parent Only
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.
Measured: baseline and immediately post intervention (T2), up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Oct 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Modified DECIDE InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- For clarity, each intervention group was separate and not comparable to other intervention groups.
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Smith College, University of South Florida, National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Ukamaka Marian Oruche, Indiana University
- Investigators
- Ukamaka M Oruche, PhD, Principal investigator, IU Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445155
- Sponsor's protocol ID
- 1911897011
- Other IDs
- 5R21MD015150-02
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2020
- Last updated
- 28 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oruche UM, Holladay CM, Chacko A, Nakash O, Draucker CB. Development and Acceptability of Provider Training to Increase Treatment Engagement of Parents in Their Children's Behavioral Health Care Need. J Am Psychiatr Nurses Assoc. 2024 Nov-Dec;30(6):927-939. doi: 10.1177/10783903241284014. Epub 2024 Oct 8.
PubMed 39377512Oruche UM, Nakash O, Holladay C, Chacko A, Perkins SM, Draucker CB. Implementation of Research in Community Mental Health Centers: The Challenge of Provider Engagement. Community Ment Health J. 2024 Oct;60(7):1247-1254. doi: 10.1007/s10597-024-01282-7. Epub 2024 Apr 26.
PubMed 38668829
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04445155
- Acronym / sponsor ID
- 1911897011
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Smith College, University of South Florida, National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Posted 28 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- For clarity, each intervention group was separate and not comparable to other intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Modified DECIDE-Provider Arm | Experimental | Behavioral: Modified DECIDE Parent and Provider Intervention2-4 hour workshop for providers to improve perspective-taking, reduce attributional errors, and increase receptivity to parent participation. |
| Modified DECIDE-Parent Arm | Experimental | Behavioral: Modified DECIDE Parent and Provider InterventionUp to three parent training sessions designed to help patients effectively ask questions and participate in decisions about care. |
| Provider Subgroup Study | Other | Behavioral: Modified DECIDE Parent and Provider InterventionTo 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. |
| Treatment as Usual | No intervention | –Control arm |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Inclusion Criteria for providers and interns: Providers will be regular paid staff members who are:
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified DECIDE Parent and Provider InterventionThe 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. | Behavioural | Modified DECIDE-Parent Arm, Modified DECIDE-Provider Arm, Provider Subgroup Study |
Primary outcome
Change in Parent Needs & Resources Domain of CANS - Provider Arm Only
Time frame: 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
Time frame: 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.
7 secondary outcomes
Change in Parent Participation Engagement Measure (PPEM) - Provider and Parent Arm Only
Time frame: baseline and immediately post intervention (T2), up to 4 weeks
Change in Familiarity With Perspective Taking - Provider Arm and Provider Subgroup Arm Only
Time frame: baseline and immediately post intervention (T2), up to 4 weeks
Change in Familiarity With Attribution Errors - Provider Arm and Provider Subgroup Arm Only
Time frame: baseline and immediately post intervention (T2), up to 4 weeks
Change in Familiarity With Receptivity - Provider Arm and Provider Subgroup Arm Only
Time frame: 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
Time frame: baseline and immediately post intervention (T2), up to 4 weeks
Change in Perceived Efficacy in Parent-Physician Interactions (PEPPI)-Short Form: Post-intervention - Parent Arm Only
Time frame: baseline and immediately post intervention (T2), up to 4 weeks
Change in Perception of Care Quality Survey: Post-intervention - Parent Only
Time frame: baseline and immediately post intervention (T2), up to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39377512Oruche UM, Holladay CM, Chacko A, Nakash O, Draucker CB. Development and Acceptability of Provider Training to Increase Treatment Engagement of Parents in Their Children's Behavioral Health Care Need. J Am Psychiatr Nurses Assoc. 2024 Nov-Dec;30(6):927-939. doi: 10.1177/10783903241284014. Epub 2024 Oct 8.
- Derived from this study: PubMed 38668829Oruche UM, Nakash O, Holladay C, Chacko A, Perkins SM, Draucker CB. Implementation of Research in Community Mental Health Centers: The Challenge of Provider Engagement. Community Ment Health J. 2024 Oct;60(7):1247-1254. doi: 10.1007/s10597-024-01282-7. Epub 2024 Apr 26.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ukamaka M Oruche, PhD principal investigator
IU Nursing
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified DECIDE Parent and Provider Intervention in people with Modified DECIDE Intervention and Treatment as Usual Care Group, run by Indiana University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parent Needs & Resources Domain of CANS - Provider Arm Only (time frame: baseline and immediately post intervention (T2), up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445155, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.