Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04986800
Status:
WITHDRAWN
Last Update Posted:
2024-03-15
First Post:
2021-05-24
Brief Title:
Providing Access To Innovative Evidence-Based Intervention
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
PROACTIVE Parent Providing Access To Innovative Evidence-Based Intervention
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Was never funded Through rounds of grant applications the intervention changed substantially based on reviewer feedback and feasibility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROACTIVE
Brief Summary:
PROACTIVE Parent is an educational program designed to improve parenting skills to more effectively manage child behavior and social and emotional needs in children with depressive symptoms PROACTIVE Parent Providing Access To Innovative Evidence-Based Intervention is a new service delivery model that uses telehealth methodology to engage parents in managing their childs mental health needs PROACTIVE Parent aims to provide parents with information about their childs mental health symptoms and diagnosis options for evidence-based treatment interventions and a free online application for identifying appropriate and accessible treatment options PROACTIVE Parent is also designed to provide parents a deeper understanding of the function of child behavior and strategies to promote effective behavior management and healthy coping Parents will also learn skills to manage their own emotional dysregulation to promote calm parental responding and healthy parent-child interaction and communication The investigators will assess the acceptability feasibility and preliminary effectiveness of a 10-week curriculum Outcomes include parent reports of acceptability utility feasibility of program elements and the preliminary effectiveness of the program in improving parent activation parent empowerment parent emotion dysregulation and reducing child mental health and behavioral symptoms and barriers to treatment participation
Detailed Description:
PROACTIVE Parent is an educational program designed to improve parent knowledge capacity and confidence to more effectively manage child behavior and social and emotional needs in children with depressive symptoms PROACTIVE Parent Providing Access To Innovative Evidence-Based Intervention is a new service delivery model that uses telehealth methodology to educate parents about their childs mental health MH symptoms and treatment teach parents skills to promote a safe regulated environment for their youth and teach parents how to work with their childs therapists to support treatment goals at home and in the community PROACTIVE Parent will teach parents the function of child behavior the role of symptomatology in child behaviors and strategies to promote effective behavior management and healthy coping Parents will also learn skills to manage their own emotional dysregulation to promote calm parental responding and promote healthy parent-child interaction and communication
The PROACTIVE Parent model is ideally suited to promote parents active management of child MH care Children depend on parents to navigate a complex system of care and support childrens coping in the home and community However parents may not know how to navigate appropriate treatments how to communicate with their childs therapist to support treatment goals in the home or how to interact with their child in a way that supports positive mental health outcomes These parents require a service model that builds parent capacity to manage their childs MH care The conceptual framework for the proposed work draws on the concept of parent activation and engagement in their childs MH care and regulating affect Activation refers to the parents knowledge capacity and commitment to manage their childs MH care Engagement refers to actions parents take to manage their childs care Emotion regulation skills help parents to manage their affect to engage in calm responding to childrens needs and assist children in regulating affect
PROACTIVE Parent is delivered in weekly 30-minute telehealth coaching sessions over the course of 10 weeks Parent coaches use motivational interviewing and psychoeducation to improve parent activation and management of their childs MH care Parent coaches provide parent-training and evidence-based skills training to promote effective parent behavior healthy coping and positive parent-child interaction The parent coach will deliver the PROACTIVE Parent model via telehealth with supplemental online resources using a publically available service referral system to connect parents to evidence-based treatments and MH providers if needed
The investigators will recruit Foster Parents of youth in care aged 8 - 13 years with symptoms or history of depression to examine acceptability feasibility and preliminary effectiveness of the PROACTIVE Parent program
The Aims of this project include an open trial and exploration of the relationship between parent activation and youth MH outcomes
Aim 1 Conduct a pilot study to test acceptability utility feasibility and preliminary effectiveness The primary outcomes include 1 Acceptability 2 Usefulness and 3 Feasibility all measured by post-session questions and post-intervention Customer Satisfaction Survey Feasibility will also include number of people referred who meet eligibility number of parents who enroll after referral time to complete assessments Aim 2 Assess the preliminary effectiveness of the model to improve parent activation and empowerment Aim 3 Assess the preliminary effectiveness to reduce the number severity and frequency of child MH symptoms and maladaptive behaviors Aim 4 Assess preliminary effectiveness of improving parent scores on the DERS and barriers to treatment participation
If the PROACTIVE Parent model demonstrates feasibility and effectiveness it could serve as a model for scaling up to a population-based approach to MH treatment for all children
The PROACTIVE Parent model is ideally suited to promote parents active management of child MH care Children depend on parents to navigate a complex system of care and support childrens coping in the home and community However parents may not know how to navigate appropriate treatments how to communicate with their childs therapist to support treatment goals in the home or how to interact with their child in a way that supports positive mental health outcomes These parents require a service model that builds parent capacity to manage their childs MH care The conceptual framework for the proposed work draws on the concept of parent activation and engagement in their childs MH care and regulating affect Activation refers to the parents knowledge capacity and commitment to manage their childs MH care Engagement refers to actions parents take to manage their childs care Emotion regulation skills help parents to manage their affect to engage in calm responding to childrens needs and assist children in regulating affect
PROACTIVE Parent is delivered in weekly 30-minute telehealth coaching sessions over the course of 10 weeks Parent coaches use motivational interviewing and psychoeducation to improve parent activation and management of their childs MH care Parent coaches provide parent-training and evidence-based skills training to promote effective parent behavior healthy coping and positive parent-child interaction The parent coach will deliver the PROACTIVE Parent model via telehealth with supplemental online resources using a publically available service referral system to connect parents to evidence-based treatments and MH providers if needed
The investigators will recruit Foster Parents of youth in care aged 8 - 13 years with symptoms or history of depression to examine acceptability feasibility and preliminary effectiveness of the PROACTIVE Parent program
The Aims of this project include an open trial and exploration of the relationship between parent activation and youth MH outcomes
Aim 1 Conduct a pilot study to test acceptability utility feasibility and preliminary effectiveness The primary outcomes include 1 Acceptability 2 Usefulness and 3 Feasibility all measured by post-session questions and post-intervention Customer Satisfaction Survey Feasibility will also include number of people referred who meet eligibility number of parents who enroll after referral time to complete assessments Aim 2 Assess the preliminary effectiveness of the model to improve parent activation and empowerment Aim 3 Assess the preliminary effectiveness to reduce the number severity and frequency of child MH symptoms and maladaptive behaviors Aim 4 Assess preliminary effectiveness of improving parent scores on the DERS and barriers to treatment participation
If the PROACTIVE Parent model demonstrates feasibility and effectiveness it could serve as a model for scaling up to a population-based approach to MH treatment for all children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None