CancerPhase 1/2NCT02647684
Triple P for Parents of Children With a Diagnosis of Cancer
A Phase 1/2 study testing Self-Directed Triple P in people with Cancer, run by University of Manchester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer
- What is being tested?
- Self-Directed Triple P
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Aug 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Improving quality of life as measured by the Royal Marsden Hospital Paediatric Oncology Quality of Life Questionnaire (RMH-PQLQ) (Primary outcome).
- 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).
- 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).
- Conditions
- Cancer
- Being tested
- Self-Directed Triple P
- Keywords
- Cancer, Parenting, Self-directed Triple P
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Directed Triple PBehavioural
Also called Triple P
10 Week Triple P Self directed workbook
| Study group | Role | What they receive |
|---|---|---|
| Self- Direced Triple P | Experimental | 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. Receives: Behavioral: Self-Directed Triple P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life as measured by Royal Marsden Hospital Paediatric Oncology Quality of Life Questionnaire (RMH-PQLQ)
Improving quality of life
Measured: Week 1, Week 5, Week 10 and 1 month following completion.
Secondary outcomes (4)
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).
Measured: 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)
Promoting change in parenting style
Measured: Week 1, Week 5, Week 10 and 1 month following completion.
Change in parental confidence as measured by Parenting Sense of Competence Questionnaire (PSOC)
Feelings about being a parent \& confidence
Measured: 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
thoughts and feelings related to parenting a child who has experienced a chronic illness or been diagnosed with another medical condition
Measured: Week 1, Week 5, Week 10 and 1 month following completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Children's Hospital
- Responsible party
- Principal investigator, Katie Swift, University of Manchester
- Investigators
- Katie Swift, BSc, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647684
- Sponsor's protocol ID
- 163356/15EM/0101
- Status last verified
- Oct 2016
- First submitted
- 23 Sep 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple P for Parents of Children With a Diagnosis of Cancer
- ClinicalTrials.gov ID
- NCT02647684
- Acronym / sponsor ID
- 163356/15EM/0101
- Conditions
- Cancer
- Keywords
- Cancer, Parenting, Self-directed Triple P
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Royal Children's Hospital
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Improving quality of life as measured by the Royal Marsden Hospital Paediatric Oncology Quality of Life Questionnaire (RMH-PQLQ) (Primary outcome).
- 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).
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self- Direced Triple P | Experimental | Behavioral: Self-Directed Triple PSelf-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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is willing and able to give informed consent for participation in the trial.
Key exclusion criteria (4 listed)
- Children between the ages of 0 to 2 years and 11 months and 11 years upwards
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Directed Triple PAlso: Triple P10 Week Triple P Self directed workbook | Behavioural | Self- Direced Triple P |
Primary outcome
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
4 secondary outcomes
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
Change in parenting style as measured by Parenting Scale (PS)
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Swift, BSc principal investigator
The University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Self-Directed Triple P in people with Cancer, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.