Clinical trial NCT02758639: Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Psychological Adjustment
Keywords: parental cancer
children psychosocial adjustment
psychosocial intervention
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Wonders & Worries
First posted: 2016-05-02
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Child's Anxiety level (RCMAS) from baseline to 6 weeks and 8 week follow up
timeFrame: Baseline, 6 week, 8 week follow up
measure: Change in Child's Emotional/Behavioral Status (CBCL) from baseline to 6 weeks and 8 week follow up
timeFrame: Baseline, 6 week, 8 week follow up
measure: Change in Family Communication Scale FACES IV from baseline to 6 weeks and 8 week follow up
timeFrame: Baseline, 6 week, 8 week follow up
measure: Change in The Family Quality of Life Scale (FQOL) from baseline to 6 weeks and 8 week follow up
timeFrame: Baseline, 6 week, 8 week follow up
measure: Change in Cancer Self-Efficacy Scale (CASE) from baseline to 6 weeks and 8 week follow up
timeFrame: Baseline, 6 week, 8 week follow up
measure: Change in Spielberger State-Trait Anxiety Inventory (STAI) from baseline to 6 weeks and 8 week follow up
timeFrame: Baseline, 6 week, 8 week follow up
measure: Change in Depression scale (CES-D) from baseline to 6 weeks and 8 week follow up
timeFrame: Baseline, 6 week, 8 week follow up
measure: Change in Parenting Concerns Questionnaire (PCQ) for adults with cancer from baseline to 6 weeks and 8 week follow up
timeFrame: Baseline, 6 week, 8 week follow up
measure: Change in child's worries about their parent's illness from baseline to 6 weeks and 8 week follow up
timeFrame: Baseline, 6 week, 8 week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Farya Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phillips F, Prezio EA. Wonders & Worries: evaluation of a child centered psychosocial intervention for families who have a parent/primary caregiver with cancer. Psychooncology. 2017 Jul;26(7):1006-1012. doi: 10.1002/pon.4120. Epub 2016 Mar 8.
citation: Phillips F, Prezio EA, Currin-McCulloch J, Jones BL. Wonders & Worries: A randomized clinical trial of a psychosocial intervention for children who have a parent with cancer. Psychooncology. 2022 Aug;31(8):1399-1411. doi: 10.1002/pon.5943. Epub 2022 Apr 29.