Triple P for Parents of Children With a Diagnosis of Cancer

NCT02647684 | Completed Phase 1 DMC

• 1 other identifier: 163356/15EM/0101
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

Cancer; Parenting; Self-directed Triple P

Outcome Measures

Primary Outcomes (1)

• 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.

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

  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)

  Week 1, Week 5, Week 10 and 1 month following completion.

• Change in parental confidence as measured by Parenting Sense of Competence Questionnaire (PSOC)

  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

  Week 1, Week 5, Week 10 and 1 month following completion.

Study Arms (1)

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.

Behavioral: Self-Directed Triple P

Interventions

Self-Directed Triple P BEHAVIORAL

10 Week Triple P Self directed workbook

Also known as: Triple P

Self- Direced Triple P

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead
• Royal Children's Hospital: collaborator

Study Sites (1)

The University of Manchester

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

(tris(diphenylphosphinomethyl)phenylborate)(p-tolylnitrido)iron(I)

Study Officials

• Katie Swift, BSc

  The University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigaor

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

GB (1)