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临床试验/NCT02758639
NCT02758639已完成不适用

Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Change in Parenting Concerns Questionnaire (PCQ) for adults with cancer from baseline to 6 weeks and 8 week follow up

研究概览

简要总结

Parental cancer can cause substantial behavioral and emotional distress in both parent and child. Parents struggle with talking with their child about their cancer and supporting the child during treatment. Over 73% of patients with children desire information and services to support their children yet only 9% of these families report receiving this support. The purpose of this study is to evaluate the Wonders & Worries psychosocial intervention designed for children ages 5-14 who have a parent diagnosed with early stage cancer.This study is a randomized controlled clinical trial (RCT) evaluating the Wonders & Worries group and individual intervention for school age children (5 -14 years old) who have a parent with cancer. Families will be enrolled at the time of initial parent consultation, given informed consent, and then randomized either to the intervention group of 30 families or the wait-listed control group of 30 families. Both groups will be given a series of standardized validated assessment instruments including the Revised Children's Manifest Anxiety Scale (RCMAS), the Child Behavior Checklist (CBCL), and the Family Communication Scale FACES IV at baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures, families in the wait-listed control group will be enrolled into the intervention. Parent exit interviews for both groups will be used to measure parent-reported child outcomes and program utility.

详细描述

The purpose of this study is to evaluate the Wonders & Worries psychosocial intervention designed for children ages 5-14 who have a parent diagnosed with early stage cancer. The Wonders & Worries program curriculum is a psychosocial intervention that was designed to address the communication and distress issues raised in prior descriptive research and to respond to the limitations of current research. The goals of the program are to improve children's behavioral-emotional adjustment to their parent's cancer, improve parenting behavior (parenting quality, skills and self-efficacy), and increase family communication about the illness. The aim of the current study is to evaluate the efficacy of the Wonders & Worries program on child and parent outcomes within a randomized clinical trial.

Wonders & Worries is an Austin based non-profit agency. Wonders & Worries works with families in all stages of survivorship, who are affected by any serious or chronic physical illness.

The fully scripted intervention involves 6 group or individual sessions for the children, each of which is briefly summarized, in Table 1. Families will be enrolled at the time of initial parent consultation at Wonders & Worries, given informed consent, and then randomized either to the intervention group of 30 families or the wait-listed control group of 30 families. Both groups will be given a series of standardized validated assessment instruments including the Revised Children's Manifest Anxiety Scale (RCMAS), the Child Behavior Checklist (CBCL), the Family Communication Scale FACES IV, and the AMMI-EC3- About My Mommy's Illness at baseline, post intervention, and 8 week follow up. Upon completion of the follow up measures, families in the wait-listed control group will be enrolled into the intervention. Parent exit interviews for both groups will be used to measure parent-reported child outcomes and program utility.

The intervention will be provided by Wonders & Worries certified child life specialists. Child life specialists are professionals trained to help children and their families understand and manage challenging life events and stressful health care experiences. By using play, recreation, education, self-expression and theories of child development, these specialists help promote the psychological well-being and optimum development of children and families faced with stressful situations. At Wonders & Worries all services are provided by master's prepared certified child life specialists.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
5 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Families with children ages 5-14 at time of study. Children have a parent with early stage cancer, and are English-speaking.

排除标准

  • Children are not living in the home with the ill parent at least 50% of the time. Non-English speaking families.

研究组 & 干预措施

W & W Intervention

Experimental

Wonders & Worries Psychosocial intervention is a 6 week group or individual sessions for children who have a parent with cancer focusing on psycho-educational information about cancer, treatment and its side effects, feelings expression, positive coping strategies, and family communication about the illness.

干预措施: Wonders & Worries Psychosocial Intervention (Behavioral)

Wait list control

Other

Wait list group will complete baseline, 6 week and 8 week follow up measures and then will be enrolled to receive W & W intervention.

干预措施: Wonders & Worries Psychosocial Intervention (Behavioral)

结局指标

主要结局

Change in Parenting Concerns Questionnaire (PCQ) for adults with cancer from baseline to 6 weeks and 8 week follow up

时间窗: Baseline, 6 week, 8 week follow up

parent self report

Change in Spielberger State-Trait Anxiety Inventory (STAI) from baseline to 6 weeks and 8 week follow up

时间窗: Baseline, 6 week, 8 week follow up

parent self report of anxiety

Change in Child's Anxiety level (RCMAS) from baseline to 6 weeks and 8 week follow up

时间窗: Baseline, 6 week, 8 week follow up

Revised Children's Manifest Anxiety Scale - child self report

Change in Cancer Self-Efficacy Scale (CASE) from baseline to 6 weeks and 8 week follow up

时间窗: Baseline, 6 week, 8 week follow up

parent report of parenting self efficacy

Change in Child's Emotional/Behavioral Status (CBCL) from baseline to 6 weeks and 8 week follow up

时间窗: Baseline, 6 week, 8 week follow up

Child Behavior Checklist - parent report

Change in Depression scale (CES-D) from baseline to 6 weeks and 8 week follow up

时间窗: Baseline, 6 week, 8 week follow up

parent self report of depression

Change in child's worries about their parent's illness from baseline to 6 weeks and 8 week follow up

时间窗: Baseline, 6 week, 8 week follow up

child self report of worries related to parent's illness AMMI-EC3- About My Mommy's Illness

Change in Family Communication Scale FACES IV from baseline to 6 weeks and 8 week follow up

时间窗: Baseline, 6 week, 8 week follow up

parent \& child report

Change in The Family Quality of Life Scale (FQOL) from baseline to 6 weeks and 8 week follow up

时间窗: Baseline, 6 week, 8 week follow up

parent \& child report

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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