Providing Access To Innovative & Evidence-Based Intervention

NCT04986800 | Withdrawn

• 1 other identifier: STU00214486
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (6)

• Client Satisfaction Questionnaire

  The Client Satisfaction Questionnaire (CSQ) is an 8-item scale with response options ranging from 1 - 4. Total scores range from 8 -32. Higher scores indicate higher satisfaction. Assesses the extent to which parents found the intervention helpful, relevant, feasible, and effective.

  baseline

• Client Satisfaction Questionnaire

  The Client Satisfaction Questionnaire (CSQ) is an 8-item scale with response options ranging from 1 - 4. Total scores range from 8 -32. Higher scores indicate higher satisfaction. Assesses the extent to which parents found the intervention helpful, relevant, feasible, and effective.

  11 weeks

• Parent-Patient Activation Measure - Mental Health

  The Parent-Patient Activation Measure - Mental Health measures parent activation, defined as the knowledge, ability, and confidence to manage their child's mental health care. It consists of 13 items on a 4-point Likert-type scale ranging from 1-4. Item scores are summed for a total composite score ranging from 13 -52. Composite scores are linearly transformed into scores ranging from 0 - 100. Higher scores indicate higher activation in managing their child's mental health care.

  baseline

• Parent-Patient Activation Measure - Mental Health

  The Parent-Patient Activation Measure - Mental Health measures parent activation, defined as the knowledge, ability, and confidence to manage their child's mental health care. It consists of 13 items on a 4-point Likert-type scale ranging from 1-4. Item scores are summed for a total composite score ranging from 13 -52. Composite scores are linearly transformed into scores ranging from 0 - 100. Higher scores indicate higher activation in managing their child's mental health care.

  11 weeks

• Family Empowerment Scale

  The Family Empowerment Scale consists of 34-items and 3 subscales (1. Family, 2. Mental health services, 3. Community) designed to assess a parent's sense of empowerment in families of children with an emotional disorder. Response options range from 1 (not true at all) - 5 (very true). Total scores range from 34 - 170, with higher scores indicating higher levels of empowerment.

  baseline

• Family Empowerment Scale

  The Family Empowerment Scale consists of 34-items and 3 subscales (1. Family, 2. Mental health services, 3. Community) designed to assess a parent's sense of empowerment in families of children with an emotional disorder. Response options range from 1 (not true at all) - 5 (very true). Total scores range from 34 - 170, with higher scores indicating higher levels of empowerment.

  11 weeks

Secondary Outcomes (12)

• PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a (PROMIS Anxiety)

  baseline

• PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a (PROMIS Anxiety)

  11 weeks

• PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a (PROMIS Depressive)

  baseline

• PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a (PROMIS Depressive)

  11 weeks

• Pediatric Symptom Checklist - 17 (PSC-17)

  baseline

Other Outcomes (10)

• Post-Session Items

  1 week

• Post-Session Items

  2 weeks

• Post-Session Items

  3 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL

Participants in the Intervention Group will receive up to 10 sessions of the PROACTIVE Parent intervention.

Behavioral: PROACTIVE Parent

Interventions

PROACTIVE Parent BEHAVIORAL

PROACTIVE Parent will educate parents about their child's mental health symptoms and treatment, how to talk to the child's therapist 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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Study Officials

• Heather J Risser, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: August 3, 2021
• Study Start: December 1, 2024
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 28, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)