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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Cancer
Psychological Adjustment

Treatments

Behavioral: Wonders & Worries Psychosocial Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02758639
201502573

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

5 to 14 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

W & W Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Wonders & Worries Psychosocial Intervention
Wait list control
Other group
Description:
Wait list group will complete baseline, 6 week and 8 week follow up measures and then will be enrolled to receive W & W intervention.
Treatment:
Behavioral: Wonders & Worries Psychosocial Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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