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.

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

Session 1: Getting to Know Each Other The goal is to create a sense of safety within the group so that the children feel comfortable discussing difficult topics. Session 2: Cancer Education to provide developmentally appropriate education about the illness, treatment, and side effects. Session 3: Cancer Treatment Center Tour: This session consists of a treatment center tour and education about treatment plan involved in family's care in a safe environment. Session 4: Feelings: The focus of this session is expression and validation of all feelings the children may experience. Session 5: Stress and Coping: Goal is to emphasize the different ways individuals cope and differentiate positive vs. negative coping strategies. Session 6: Hopes for the Future/Closure: An emphasis is made on the idea that positive things may evolve from the most difficult circumstances.

Wonders & Worries Psychosocial Intervention

Farya Phillips, PhD

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.

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.

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

Revised Children's Manifest Anxiety Scale - child self report

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

Wonders & Worries

University of Texas at Austin

In the experimental condition, the two significant caregivers of the child or the individual caregiver receive the intervention composed of an informational booklet and a psychological intervention. The intervention consists of four sessions, centered on supporting the child in the context of parental cancer principally through communication.

Assessments are conducted at two periods : before and after the intervention.

In the control condition, the participants receive the informational booklet before being registered in a waiting list for the psychological intervention. The intervention should ideally last two months.

Assessments are conducted at 9 weeks of interval.

A psychological intervention including 4 sessions to assess how participants communicate with their children about the disease and take stock of their questions and difficulties. To identify children's reactions and needs. Practical situation are analyzed and worked through role play centered on communicational difficulties to enhance communicational self-efficacy and mutual support among participants. Emotional regulation strategies are learned through relaxation exercises. A relaxation booklet is given to the participants to practice at home too. Moreover, all participants receive an informational booklet containing age-appropriate recommendations on communication with children about cancer.

Parental guidance

Razavi

Background:

Cancer has a significant short and long-term impact on the family. Children of cancer patients may suffer from emotional, behavioral or somatic difficulties. Following the cancer diagnosis, many parents report being concerned about the impact of the illness on their children and how to communicate about the illness. In addition, they feel less able to meet the needs of their children and have difficulties regulating their emotions in response to their children's reactions.

Methods:

A randomized controlled trial was designed to assess the efficacy of a parental guidance intervention centered on communication with children in the context of a parental cancer.

This psychological intervention is designed to help parents and significant caregivers of the children. The participants are randomly assigned to either an intervention group (experimental group) or a waiting list group (control group).

The participants fill out self reported questionnaires that assess the parental self-efficacy in communication, mutual social support, communicational behaviors' with children, parenting concerns,communicational difficulties with children, knowledges about communication with children in oncological context, socio-demographical status, medical situation, psychiatric history, social difficulties and emotional state of the participants and children. The semi-structured interview with participants assesses their day to day communication with the children and the difficulties related to this communication. Those questionnaires are completed at baseline and post treatment (experimental group) and 9 weeks after baseline (control group).

This parental guidance consists of a weekly 4-session intervention. The aim of the sessions are to provide child support in the oncological context, mainly through communication.

Discussion:

This parental guidance would lead to improvements in knowledge, communication, parental self-efficacy and emotional regulation associated with child support.

Introduction :

Parents raise many questions about the impact of the cancer on their children and on the communication with them about the disease. For many of them, the cancer impact their parental self-efficacy. This decrease of self-efficacy is related to difficulties to communicate openly with children and to regulate emotions in response to the feelings, reactions and questions of their children. In the same way, some parents report a lack of knowledge on how to support their children. They express doubts concerning the way they speak about cancer with their children.

Objectives of the study :

The primary objective of this study is to test the contribution and effectiveness of a psychological intervention in relation to the delivery of an informational booklet regarding participants' communication with the child in the oncology context. This intervention should increase participants' sense of communicative competence and communicationnal behaviors with children.

The secondary objectives is to evaluate the improvement of the participants' regarding the knowledge of how to support a child facing a parent's cancer, the emotional regulating capacity associated with participants' communication with the child, the evolution of the participants' concerns about the child. When the intervention is carried out in a dyad, it should also improve mutual support between participants.

This intervention is designed to help parents and significant caregivers of the children. It is focused on child support in the oncological context, and mainly on the communication between parents and their children. This intervention consists in a brief psychological intervention focused on improving knowledge, communication, parental self-efficacy and emotional regulation associated with child support. The intervention will be customized and tailored to each family.

Participants :

All significant caregivers of a child aged between 3 and 18 and who's facing parental cancer can be included in the study. A significant caregiver is a person who takes care of children at a practical, educational and emotional level (mostly parents, step parents, legal guardians, grandparents...). The whole study (assessment procedure and psychological intervention) is realized with one or two persons involved in child support. A consent form will be completed and signed by the adult participants.

Study design :

The effectiveness of the parental support intervention is assessed through a longitudinal two arms, randomized controlled trial. The psychological intervention is proposed to the main caregivers of children confronted to parental cancer.

In the experimental condition, the two significant caregivers of the child or the individual caregiver receive the intervention composed of an informational booklet and a psychological intervention. The intervention consists of four sessions, centered on supporting the child in the context of parental cancer mainly through communication.

In the control condition, the participants receive the informational booklet before being registered in a waiting list for the psychological intervention. The intervention should ideally last two months. Assessments are conducted at two periods (T1 and T2) : before and after the intervention for the experimental group and at 9 weeks of interval for the control group. The evaluation of the intervention is conducted through questionnaires completed by participants and a semi-structured interview.

Intervention :

The intervention consists in a brief psychological intervention including four sessions, centered on supporting the children in the context of parental cancer through communication. The content of the intervention is adapted to the specific situation of each family, their difficulties and their needs.

The first session is dedicated to the assessment of how participants communicate with their children about the disease and to take stock of their questions and difficulties. In this session, the family situation and the medical context are also discussed and the parental skills are identified. The other sessions are essentially focused on the identification of children's reactions and needs in the context of cancer and on the communication with children about the disease. Practical situation are analyzed and worked through role play centered on communicational difficulties. Participants must actively participate in the intervention. Specific techniques will be used with the participants to "co-construct" personalized communication with their child and to support its implementation. This active participation aims to enhance communicational self-efficacy and mutual support among participants. During the intervention, emotional regulation strategies are also transmitted to the participants through relaxation exercises in order to cope with the emotions felt in these particular contexts. A relaxation booklet is given to the participants to practice at home the relaxation exercises learned during the sessions. Moreover, all participants (experimental and control conditions) receive an informational booklet containing age-appropriate recommendations on communication with children about cancer. This booklet aims to improve knowledge of participants on how to support their children.

Assessment procedure :

Assessments are conducted at two periods (T1 and T2) and consist of questionnaires and a semi-structured interview with each participant. For the assessment, participants must refer specifically to only one child in their circle, aged between 3 and 18 years. If several children meet these criteria, participants determine the one for whom they have the most questions regarding communication with him/her about the illness. The child thus identified serves as a reference for T1 and T2 in order to standardize the evaluation procedure as much as possible.

Some questionnaires assess the primary outcome of the study : parental self-efficacy in communication, communicational behaviors' with children. Other questionnaires assess the secondary outcome of the study: Emotional regulation, mutual support between participants, communicationnal difficulties with children, parenting concerns, knowledges about communication with children in oncological context. Many questionnaires are specifically created by the investigator's team. Other questionnaires assess control variables: the socio-demographical status, medical situation, psychiatric history, social difficulties and emotional state of the participants and children. The semi-structured interview with participants assesses their day to day communication with the children and the difficulties related to this communication. Each semi-structured interview takes approximatively 20 minutes and is recorded and transcribed.

The sample size has been calculated a priori in order to detect the differences in the evolution of the two groups (experimental and control conditions) between T1 and T2.

The sample size calculation was done with the software G\*Power. The power analysis has been based on a previous pilot study assessing the efficacy of the intervention on patient. Self-efficacy score have been considered to perform the power analysis (Change over time in Experimental Group: Delta T2-T1 Mean = 0.9514; SD = 0.8043; Change over time Control Group is consider as zero). The effect size was 1.183 for a power of 0.90 in two-side. Based on this result but considering the small sample of the pilot study, the sample size calculation has been based on a 0.9% power, an effect-size of 0.9 and a two-sided α = 0.05 t-test. Considering this power analysis, 54 evaluable patients are therefore needed for the efficacy assessment. Considering a drop-out rate of approximately 10%, 6 patients should be moreover recruited. The aim of the study is therefore to recruit 60 patients.

The effectiveness of the parental support intervention is assessed through a longitudinal two arms, randomized controlled trial and the experimental condition, the two significant caregivers of the children or the individual caregiver receive the intervention composed of an informational booklet and a psychological intervention. In the control condition, the participants receive the informational booklet before being registered in a waiting list for the psychological intervention. The intervention should ideally last two months. Assessments are conducted at two periods : before and after the intervention for the experimental group and at 9 weeks of interval for the control group.

Parental Support Intervention in the Oncological Context

Children Facing Parental Cancer : a Randomized Controlled Study Evaluating the Efficacy of a Psychological Intervention to Support Parenting

Assessment through a self-reported scale created for the study and completed by the participants named "Sense of communicational competence with the child". The questionnaire is composed of 16 items. The scale represents the level of certainty regarding the proposed items. The questionnaire has a 10 points Likert scale. The scale ranges is from 0 to 10. 0 means " not at all certain " and 10 "quite certain". Change in the parental self-efficacy in communication is assessed by comparing the questionnaire completed in T1 with the one completed in T2.

Parental self-efficacy is also analyzed through a content analysis of the responses given by the participants in the semi-structured interview. The presence of words such as confident, capable or opposite will provide insight into the sense of parental self-efficacy. Comparing the responses in T1 with those in T2 will highlight the change of parental self-efficacy through the increase or decrease in the occurrence of a word.

Assessment through a content analysis of the responses given by the participants in the semi-directive interview. The main domains explore by the semi directive interview are: description of the communication, feelings during the communication and communicational behaviors. Comparing the responses in T1 with those in T2 will highlight the evolution of the communicational behaviors with the child.

Assessed through a validated self-reported scale: The Hospital Anxiety and Depression Scale (HADS). It is composed by two dimensions (anxiety and depression) and has a 4 point Likert scale that vary at each item. HADS provides a total score (0-42 range) by summing all item scores. A higher score reflects a higher emotional distress. Anxiety subscale score (0-21 range) is provided by summing all Anxiety-items. A higher score reflects more anxiety. Depression subscale scores (0-21 range) is provided by summing all Depression-items. A higher score reflects more depression.

Communicational difficulties are assessed through a self-reported scale created for the study and completed by the participants named "Communication difficulties with the child ". The scale is composed of 13 items which represents the level of truth regarding the proposed items. The questionnaire has a 4 points Likert scale. The scale ranges is from "yes" to "no ". The evolution of the communicational difficulties is assessed by comparing the questionnaire completed in T1 with the one completed in T2.

The Communicational difficulties with children are also analysed through a content analysis of the responses given by the participants in the semi-directive interview. The main domains explore by the semi directive interview are: description of the communication, feelings during the communication and communicational behaviors. Comparing the responses in T1 with those in T2 will highlight the evolution of the communicational difficulties.

Mutual support between participants is assessed through a self-reported scale created for the study and completed by the participants named "Mutual support between participants". The scale is composed of 8 items which represents the level of truth regarding the proposed items. The questionnaire has a 4 points Likert scale. The scale ranges is from "yes" to "no". The evolution of the mutual support between participants is assessed by comparing the questionnaire completed in T1 with the one completed in T2.

Parents' concerns are assessed through a self-reported scale created for the study and completed by the participants named "concerns about the identified child". The scale is composed of 14 items which represents the level of truth regarding the proposed items. The questionnaire has a 5 points Likert scale. The scale ranges is from "Not at all concerned" to "deeply concerned". The evolution of parenting concerns is assessed by comparing the questionnaire completed in T1 with the one completed in T2.

Assessment through a self-reported scale created for the study and completed by the participants named "Knowledge of the child's level of understanding about cancer". It is composed by 10 items that describe a child's ability to understand cancer disease. The questionnaire has a 2 points Likert scale, "yes" or "no". The expected answers are 6 yes and 4 no. The answers will show the level of knowledge of the participant (good, medium or bad) regarding the understanding of children. The evolution of the knowledges of the participant about the understanding of children in oncological context is assessed by comparing the questionnaire completed in T1 with the one completed in T2.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer	NCT02758639	Cancer Psychological A...	Wonders & Worri...	5 Years - 14 Years	University of Texas at Austin
Wonders & Worries: A Clinical Trial of a Psychosocial Intervention for Children Who Have a Parent With Cancer	NCT02758639	Cancer Psychological A...	Wonders & Worri...	5 Years - 14 Years	University of Texas at Austin
Parental Support Intervention in the Oncological Context	NCT03905278	Parent-Child Re... Parenting Communication P...	Parental guidan...	3 Years - 18 Years	Université Libre de Bruxelles

Spots Global Cancer Trial Database for parental cancer