Clinical trial NCT04986800: Providing Access To Innovative & Evidence-Based Intervention
Official title: PROACTIVE Parent: Providing Access To Innovative & Evidence-Based Intervention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A service delivery model and telehealth methodology to deliver a combination of mental health evaluation of the child, motivational interviewing, transdiagnostic and evidence-based skills training (ST), and parent training (PT) to parents.
Primary purpose: TREATMENT

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 child's mental health needs. PROACTIVE Parent aims to provide parents with information about their child's 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 child's 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 child's 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 parent's active management of child MH care. Children depend on parents to navigate a complex system of care and support children's coping in the home and community. However, parents may not know how to navigate appropriate treatments, how to communicate with their child's 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 child's MH care. The conceptual framework for the proposed work draws on the concept of parent activation and engagement in their child's MH care, and regulating affect. Activation refers to the parent's knowledge, capacity, and commitment to manage their child's MH care. Engagement refers to actions parents take to manage their child's care. Emotion regulation skills help parents to manage their affect, to engage in calm responding to children's 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 child's 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.

Eligibility criteria: Inclusion Criteria

* Foster parent of child aged 8 - 13 years old with mental health symptoms
* Has access to a device and internet to allow videoconferencing or phone coaching

Exclusion Criteria

* Not currently parenting a child with symptoms or history of depression
* Does not speak English
* Does not have access to a device and internet to allow videoconferencing or phone coaching

Primary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: baseline
measure: Client Satisfaction Questionnaire
timeFrame: 11 weeks
measure: Parent-Patient Activation Measure - Mental Health
timeFrame: baseline
measure: Parent-Patient Activation Measure - Mental Health
timeFrame: 11 weeks
measure: Family Empowerment Scale
timeFrame: baseline
measure: Family Empowerment Scale
timeFrame: 11 weeks
Secondary outcomes:
measure: PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a (PROMIS Anxiety)
timeFrame: baseline
measure: PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a (PROMIS Anxiety)
timeFrame: 11 weeks
measure: PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a (PROMIS Depressive)
timeFrame: baseline
measure: PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a (PROMIS Depressive)
timeFrame: 11 weeks
measure: Pediatric Symptom Checklist - 17 (PSC-17)
timeFrame: baseline
measure: Pediatric Symptom Checklist - 17 (PSC-17)
timeFrame: 11 weeks
measure: Barriers to Treatment Participation Scale; subscales I - IV
timeFrame: baseline
measure: Barriers to Treatment Participation Scale; subscale V
timeFrame: baseline
measure: Barriers to Treatment Participation Scale; subscales I - IV
timeFrame: 11 weeks
measure: Barriers to Treatment Participation Scale; subscale V
timeFrame: 11 weeks
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: baseline
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 11 weeks
Other outcomes:
measure: Post-Session Items
timeFrame: 1 week
measure: Post-Session Items
timeFrame: 2 weeks
measure: Post-Session Items
timeFrame: 3 weeks
measure: Post-Session Items
timeFrame: 4 weeks
measure: Post-Session Items
timeFrame: 5 weeks
measure: Post-Session Items
timeFrame: 6 weeks
measure: Post-Session Items
timeFrame: 7 weeks
measure: Post-Session Items
timeFrame: 8 weeks
measure: Post-Session Items
timeFrame: 9 weeks
measure: Post-Session Items
timeFrame: 10 weeks
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Heather J Risser, PhD
role: PRINCIPAL_INVESTIGATOR
References: