跳至主要内容
临床试验/NCT04986800
NCT04986800撤回不适用

PROACTIVE Parent: Providing Access To Innovative & Evidence-Based Intervention

Northwestern University1 个研究点 分布在 1 个国家开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Client Satisfaction Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Intervention Group

Experimental

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

干预措施: PROACTIVE Parent (Behavioral)

结局指标

主要结局

Client Satisfaction Questionnaire

时间窗: 11 weeks

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.

Family Empowerment Scale

时间窗: 11 weeks

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.

Parent-Patient Activation Measure - Mental Health

时间窗: 11 weeks

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.

Client Satisfaction Questionnaire

时间窗: baseline

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.

Parent-Patient Activation Measure - Mental Health

时间窗: baseline

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.

Family Empowerment Scale

时间窗: baseline

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.

次要结局

  • PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a (PROMIS Anxiety)(11 weeks)
  • PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a (PROMIS Depressive)(11 weeks)
  • Pediatric Symptom Checklist - 17 (PSC-17)(11 weeks)
  • Barriers to Treatment Participation Scale; subscales I - IV(11 weeks)
  • Barriers to Treatment Participation Scale; subscale V(11 weeks)
  • Difficulties in Emotion Regulation Scale (DERS)(11 weeks)
  • Difficulties in Emotion Regulation Scale (DERS)(baseline)
  • PROMIS Parent-Proxy Pediatric Anxiety Short Form 8a (PROMIS Anxiety)(baseline)
  • PROMIS Parent-Proxy Pediatric Depressive Symptoms Short Form 8a (PROMIS Depressive)(baseline)
  • Pediatric Symptom Checklist - 17 (PSC-17)(baseline)
  • Barriers to Treatment Participation Scale; subscales I - IV(baseline)
  • Barriers to Treatment Participation Scale; subscale V(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Risser

Assistant Professor

Northwestern University

研究点 (1)

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