Triple P for Parents of Children With a Diagnosis of Cancer

Cancer Clinical Trial

Official title:

Triple P for Parents of Children With a Diagnosis of Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647684
• Other study ID #: 163356/15EM/0101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 23, 2015
• Last updated: October 24, 2016
• Start date: January 2016
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the characteristics of parents who enroll in parenting interventions and to assess the utility and efficacy of a self-directed Triple-P intervention for parents of children with a diagnosis of cancer. The study aims to recruit parent(s) or primary caregiver of children with a diagnosis of cancer.Participants will be parents of children aged between 3-10 years who have had a diagnosis of cancer for 6 months or more. Recruitment will take place nationally via cancer voluntary groups/charities and other relevant organisations. The project will be advertised through these organisations and their various media outlets such as newsletters and social media pages (e.g. Facebook). All data collection will take place online. Following completion of the initial survey, parents will have the option to opt in to a case series whereby 10 parents will have the opportunity to receive the Triple P Every parents self- directed workbook to complete over 10 weeks.

Description:

The risk of developing cancer in childhood is around 1 in 500, with leukemia being the most common diagnosis. Eight out of ten children now survive for five years or more. Consequently, there is a growing need to support the survivors of cancer and their families post treatment, particularly in relation to psychosocial well-being. Despite some children achieving good psychological adjustment, there is an increasing recognition of emotional and behavioural problems in child cancer survivors. Children with cancer have shown significantly higher scores for hyperactivity/impulsivity, rule-breaking behaviours and aggressive behaviours when compared to healthy controls.

The Triple P - Positive Parenting Program is a successful treatment for emotional and behavioural difficulties designed to improve the quality of parenting advice available to parents through a multilevel system intervention. All forms of Triple P have shown to have moderate to large effects on parent reported child behaviours. More recently, self-directed Teen Triple P has been shown to be effective in reducing illness related conflict and behavioural problems in adolescents with type-1 diabetes.

There is emerging research addressing the predictors and barriers of parental enrolment and engagement to parenting programmes. Historically, factors studied in relation to participation and engagement have been limited in scope and often include socioeconomic disadvantage perceived need for help and rates of problem behaviours. Little is known about the parent factors associated with participation, particularly in a cancer population. Caring for a child with a chronic illness, such as cancer, typically causes significant and prolonged distress for parents. Whilst parental motivation has been shown to indicate engagement, stress and helplessness and increased negative life events have been linked to reduced efficacy and non- completion. However, there is a paucity of research indicating whether such factors affect enrolment for parents of children with a diagnosis of cancer.

A need for parenting information has been demonstrated by Williams et al who report that parents require information about parenting strategies particularly to manage challenging behaviours being exhibited by their child. In addition, at a local level, a survey undertaken with parents of children with a diagnosis of cancer attending the oncology service at the Royal Manchester Children's hospital has indicated a need for intervention, which is accessible and provides written support to parents for managing children's behavioural difficulties. The survey identified that 97% of parents believe parenting information should be given as a matter of routine following a child's diagnosis of cancer. Furthermore, parents reported a need for support with a range of behavioural difficulties, including tantrums and angry outbursts (43%). The purpose of the current study is to examine the predictors of parental enrollment to and pilot the efficacy of a self -directed version of the Triple P - Positive Parenting Program for parents of children with a diagnosis of cancer. Specifically the investigators aim to address whether a parent's experiences of their child's illness affects their ability to enroll to the study and whether Triple P is a suitably accessible intervention for parents of children with a diagnosis of cancer. Research suggests that interventions with minimal or no therapist or methods which promote self-regulation, such as written work books with self-directed exercises can be effectively employed to address child behaviour problems.To date, there have been no studies investigating self-directed measures to help parenting in the context of children with cancer. It is hoped the proposed project will determine the efficacy of this.

Aims:

To investigate the predictors of enrolment to a self-directed Triple P- Positive Parenting Program for parents of children with a diagnosis of cancer aged 3 to 10 years. Specifically, testing whether parents' perceived distress and emotional resource (as measured by the Parents Experience of Child Illness Questionnaire, PECI), psychosocial risk factors (as measured by the Family Background questionnaire; FBQ), parenting style (as measured by the parenting style questionnaire; PS), parental confidence (as measured by the parenting sense of competency questionnaire; PSOC), number of behavioural difficulties (measured by the Royal Marsden Hospital Pediatric Oncology quality of life measure; RMH-PQLQ), quality of life (measured by RMH-PQLQ) and cancer diagnosis predict enrolment to the intervention.

To assess the effectiveness of a self-directed Triple-P Positive Parenting Program in:

1. Improving quality of life as measured by the Royal Marsden Hospital Paediatric Oncology Quality of Life Questionnaire (RMH-PQLQ) (Primary outcome).

2. Reducing behavioural difficulties as measured by the Royal Marsden Hospital Paediatric Oncology Quality of Life Inventory (RMH-PQLQ) Life Questionnaire (Q's 47-67) (Secondary Outcome).

3. Promoting change in parenting style and feelings about being a parent as measured by the Parenting Scale (PS) and Parent self -confidence as measured by the Parenting Sense of Competence Questionnaire (PSOC) (Secondary Outcome).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the trial.

• Parent of a child with a diagnosis of cancer

• Child has had cancer diagnosis for 6 months or more

• Parent of a child aged between 3 and 10 years old

• Parent can read unsupported

• Parent and Child do not have a mental health diagnosis

Exclusion Criteria:

• Children between the ages of 0 to 2 years and 11 months and 11 years upwards

• Children or parent has a mental health diagnosis

• Parent unable to read without support or assistance

• Parents of child who has been diagnosed with cancer for less than 6 months

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Self-Directed Triple P
10 Week Triple P Self directed workbook

Locations

Country	Name	City	State
United Kingdom	The University of Manchester	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	Royal Children's Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of life as measured by Royal Marsden Hospital Paediatric Oncology Quality of Life Questionnaire (RMH-PQLQ)	Improving quality of life	Week 1, Week 5, Week 10 and 1 month following completion.	No
Secondary	Change in behavioural and emotional difficulties as measured by Royal Marsden Hospital Paediatric Oncology Quality of Life Inventory (RMH-PQLQ) Life Questionnaire	Reducing behavioural and emotional difficulties (Q's 47-67) (Secondary Outcome).	Week1, (baseline between 1-3 weeks), week 5, Week 10 and 1 month following completion	No
Secondary	Change in parenting style as measured by Parenting Scale (PS)	Promoting change in parenting style	Week 1, Week 5, Week 10 and 1 month following completion.	No
Secondary	Change in parental confidence as measured by Parenting Sense of Competence Questionnaire (PSOC)	Feelings about being a parent & confidence	Week 1, Week 5, Week 10 and 1 month following completion.	No
Secondary	Change in parents thoughts and feelings related to parenting a child with cancer as measured by Parent Experience of Childhood Illness questionnaire	thoughts and feelings related to parenting a child who has experienced a chronic illness or been diagnosed with another medical condition	Week 1, Week 5, Week 10 and 1 month following completion.	No