Clinical trial NCT02501369: Investigating the Use of a Positive Parenting Programme to Improve Treatment Adherence in Cystic Fibrosis
Official title: A Case Series Examining the Impact of a Positive Parenting Program (Self Directed Teen Triple P) on Treatment Adherence in Families With an Adolescent With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2015-07-17
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cystic fibrosis (CF) is an illness that makes the lungs clog up with sticky mucus. There is no cure and so treatments are used to help make the illness easier to live with. The treatment can take lots of time and can feel not very nice sometimes. When children with CF become teenagers they need to learn to take charge of their treatment. This can be difficult. Teenagers with CF want to fit in with friends and can become more upset about their illness. Their parents have to learn to let their child take charge of their illness which can be hard for parents. These issues can put strain on parent-child relationships and this can make it harder for teenagers to stick to their treatment plans. A parenting program (called Teen Triple P) has been shown to help teenagers with other illnesses (such as diabetes) to be able to stick to their treatment plans. Parents are given a booklet to work through at home which helps them to build on the skills they already have. It aims to help families to support positive parent-child relationships, to manage difficult teenage behaviours, and to teach new skills and behaviours. So far no one has done any research to see if this program helps families of teenagers with CF. This research would like to see if the Triple P program can help teenagers with CF stick to their treatment plan. Helping teenagers stick to their treatment plan will help them to live happier and healthier lives.

Detailed description: The aim of this case series is to begin to explore whether the Teen Triple P program may improve treatment adherence, parent-child relationships, parenting experiences and parent and adolescent wellbeing in families with an adolescent with CF. Research commonly reports that adherence rates to treatment are consistently lower in this age group, with variables such as parent-child conflict, parent stress and the child's increasing independence all being influential factors. Previous research has suggested that family based interventions may facilitate with treatment adherence in this population, but little research has investigated the effectiveness of specific parenting and family based interventions. Triple P is an internationally recognized and extensively researched parenting intervention that has been found to support families from an array of clinical and non-clinical samples, and has been shown to reduce family conflict in other chronic health conditions. No research to date has examined the use Triple P interventions in cystic fibrosis and so hence the current research.

A within subjects clinical case series using an A-B multiple baseline design will be used. This type of design exposes participating parents to a multiple baseline period (phase A) followed by an intervention phase (phase B). This controls for potential confounds, which increases confidence that change is attributable to the use of the parenting intervention. The baseline phase will vary in length from 2 to 6 weeks. During this phase, parents will complete the treatment adherence questionnaire and parenting scale (outlined in the outcome measures section) at weekly intervals which will take 10 minutes each week (the first and last baseline session will involve completing all questionnaires stated in the primary and secondary outcome measures section). The baseline phase will be followed by the 10 week intervention phase. Here parents will commence the self-directed Teen Triple P programme. Parents will be posted a copy of the Teen Triple P workbook. They will complete a 1 hour module of Triple P each week and will also continue to complete the treatment adherence questionnaire and parenting scale each week. At week 5 and 10 of the intervention, the full set of outcome questionnaires will be administered, as well as a satisfaction survey to determine how parents are finding the Triple P intervention. Once the 10 week Triple P intervention has been completed a period of 4 weeks will elapse before the researcher will contact the parents again in order for them to complete a set of 1 month follow up questionnaires, as well as answering some questions about their experiences of taking part in the Triple P intervention.

Children themselves will not be required to participate in any study related activity as this is primarily a parenting intervention.

Eligibility criteria: Inclusion Criteria:

* Parents of adolescents (aged 11 to 16) with Cystic Fibrosis.
* Self reported difficulties with their child's treatment adherence.

Exclusion Criteria:

* Families already receiving psychological support from specialist Cystic Fibrosis clinical psychologists
* Parents requiring reading assistance who do not have anyone to help them
* Families where the parent/ child is currently being treated for a mental health difficulty

Primary outcomes:
measure: Change in Treatment Adherence from baseline as measured by Treatment Adherence Questionnaire - Revised (Quittner et al., 2008)
timeFrame: baseline, intervention weeks 1, 2,3,4,5,6,7,8,9,10, and 1 month follow up
measure: Change in parenting skill and competence from baseline as measured by The Parenting Scale (PS; Arnold et al., 1993)
timeFrame: baseline, intervention weeks 1, 2,3,4,5,6,7,8,9,10, and 1 month follow up
Secondary outcomes:
measure: Change in parent stress from baseline as measured by Pediatric Inventory for Parents: PIP (Streisand et al., 2001)
timeFrame: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
measure: Change in parent's sense of competence from baseline as measured by Parent Sense of Competency Scale (PSOC; Gibaud-Wallston & Wandersman, 1978)
timeFrame: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
measure: Change in child's emotional wellbeing and behavioural difficulties from baseline as measured by Strengths and Difficulties Questionnaire (SDQ: Goodman, 1997)
timeFrame: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
measure: Change in parent emotional wellbeing from baseline as measured by The Depression, Anxiety and Stress Scale - 21 item version (DASS-21)
timeFrame: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
Other outcomes:
measure: Parent satisfaction with the intervention at mid and end intervention points as measured by Client Satisfaction Questionnaire
timeFrame: weeks 5 and 10 of intervention
Locations:
Study officials:
affiliation: University of Manchester
name: Rachel Calam, PhD
role: PRINCIPAL_INVESTIGATOR
References: