Clinical trial NCT03905278: Parental Support Intervention in the Oncological Context
Official title: Children Facing Parental Cancer : a Randomized Controlled Study Evaluating the Efficacy of a Psychological Intervention to Support Parenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Parenting
Communication Programs
Keywords: parental cancer
parental guidance
parent-child communication
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
Collaborators: name: Centre de Psycho-Oncologie (CPO)
name: Erasme University Hospital
name: Jules Bordet Institute
name: Université Libre de Bruxelles
First posted: 2019-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Significant caregiver of a child aged between 3 and 18 who's facing parental cancer
* Participants must be of legal age
* Participants must not have an acute psychiatric or neurological disorder
* Participants must have sufficient command of French (speaking, writing, reading)
* Completing a written informed consent

Exclusion Criteria:

* Pre-terminal or terminal stage of cancer of the parent
* Death of the parent

Primary outcomes:
measure: Change of the parental self-efficacy in communication
timeFrame: 8-9 weeks
measure: Change of the communicational behavior
timeFrame: 8-9 weeks
Secondary outcomes:
measure: Evaluation of the Emotional distress
timeFrame: 8-9 weeks
measure: Evaluation of the Communicationnal difficulties with the child
timeFrame: 8-9 weeks
measure: Description of the Communicationnal difficulties with the child
timeFrame: 8-9 weeks
measure: Evaluation of the mutual support between participants
timeFrame: 8-9 weeks
measure: Evaluation of parenting concerns
timeFrame: 8-9 weeks
measure: Evaluation of the knowledges of the participant about the understanding of children in oncological context
timeFrame: 8-9 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
affiliation: Universite Libre de Bruxelles
name: Razavi
role: PRINCIPAL_INVESTIGATOR
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