Triple P for Parents of Children With a Diagnosis of Cancer

October 24, 2016 updated by: Katie Swift, University of Manchester
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom
        • The University of Manchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Self- Direced Triple P
Self-directed Triple P workbook to be completed over 10 weeks. Over the course of the workbook parents will think about the changes they would like to make to their child's behaviour. They are taught strategies to enhance their relationship with their child, and promote desirable behaviours. They learn about options for managing problem behaviours and have the opportunity to decide if they would like to use any of these approaches with their child in a clear and consistent way. Parents have practice period to use the approaches they have learnt in weeks 1-3. By the end of week 6 they will have had practice in using their chosen positive parenting approaches, learnt to set goals and monitor their own behaviour when using these strategies. The final weeks aim to help parents identify times when the strategies may not be working and provide survival tips on what to do at these times.
Behavioral: Self-Directed Triple P
10 Week Triple P Self directed workbook
Other Names:
  • Triple P

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Quality of life as measured by Royal Marsden Hospital Paediatric Oncology Quality of Life Questionnaire (RMH-PQLQ)
Time Frame: Week 1, Week 5, Week 10 and 1 month following completion.
Improving quality of life
Week 1, Week 5, Week 10 and 1 month following completion.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in behavioural and emotional difficulties as measured by Royal Marsden Hospital Paediatric Oncology Quality of Life Inventory (RMH-PQLQ) Life Questionnaire
Time Frame: Week1, (baseline between 1-3 weeks), week 5, Week 10 and 1 month following completion
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
Change in parenting style as measured by Parenting Scale (PS)
Time Frame: Week 1, Week 5, Week 10 and 1 month following completion.
Promoting change in parenting style
Week 1, Week 5, Week 10 and 1 month following completion.
Change in parental confidence as measured by Parenting Sense of Competence Questionnaire (PSOC)
Time Frame: Week 1, Week 5, Week 10 and 1 month following completion.
Feelings about being a parent & confidence
Week 1, Week 5, Week 10 and 1 month following completion.
Change in parents thoughts and feelings related to parenting a child with cancer as measured by Parent Experience of Childhood Illness questionnaire
Time Frame: Week 1, Week 5, Week 10 and 1 month following completion.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manchester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Royal Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katie Swift, BSc, The University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 163356/15EM/0101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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