Cystic FibrosisNCT02501369
Investigating the Use of a Positive Parenting Programme to Improve Treatment Adherence in Cystic Fibrosis
A study testing Self-directed Teen Triple P in people with Cystic Fibrosis, run by Emma Wells.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Self-directed Teen Triple P
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jun 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents of adolescents (aged 11 to 16) with Cystic Fibrosis.
- Self reported difficulties with their child's treatment adherence.
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Self-directed Teen Triple P
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-directed Teen Triple PBehavioural
Manualised parenting programme that parents will complete at home. This involves reading weekly modules of the manual and completing small exercises to practice the skills taught. These include strategies to help build positive relationships between parent and child, helping parents to effectively manage challenging childhood behaviours, and providing parents with the skills to support their child's independence and independent management of their cystic fibrosis.
| Study group | Role | What they receive |
|---|---|---|
| Self-directed Teen Triple P | Experimental | Self-directed Teen Triple P is a behaviourally based parenting intervention that parents follow at home using a workbook. It is based upon social learning theory principles and is used to help parents build upon their existing skills and information to practice positive parenting. Key skills promoted include: Increasing positive parent-teenager interactions, increase desirable behaviour, teach new behaviours and skills, and manage problem behaviour.
As this is a case series design participants will act as their own controls and so there are no other arms to the study. Receives: Behavioral: Self-directed Teen Triple P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Treatment Adherence from baseline as measured by Treatment Adherence Questionnaire - Revised (Quittner et al., 2008)
consists of 12 items across four subscales corresponding to different domains of CF treatment regime. It asks about adherence to various elements of treatment in the last week. Answers are measured across a 6 point Likert scale ranging from "not at all" to "3 or more times a day". Internal consistency (α=.82-.84) and test-retest reliability (r's=.42-.57) have been examined. This measure takes a maximum of 5 minutes to complete.
Measured: baseline, intervention weeks 1, 2,3,4,5,6,7,8,9,10, and 1 month follow up
Change in parenting skill and competence from baseline as measured by The Parenting Scale (PS; Arnold et al., 1993)
30 item questionnaire measuring parent discipline styles. It has adequate internal consistency, good test-retest reliability and reliably distinguishes between clinical and non-clinical samples. This measure takes approximately 10 minutes to complete.
Measured: baseline, intervention weeks 1, 2,3,4,5,6,7,8,9,10, and 1 month follow up
Secondary outcomes (4)
Change in parent stress from baseline as measured by Pediatric Inventory for Parents: PIP (Streisand et al., 2001)
This has 42 items that ask parents to describe the frequency and intensity with which they experience stress related to caring for their child's illness across four domains: (a) communication (b) emotional functioning (c) child's medical care and (d) role functioning. Parents indicate on a scale from 1 (never) to 5 (very often) how often an event had occurred in the past 7 days and how difficult each event was. Internal consistency for the PIP has been shown to be good for both scales, frequency: α = .94, difficulty: α = .96
Measured: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
Change in parent's sense of competence from baseline as measured by Parent Sense of Competency Scale (PSOC; Gibaud-Wallston & Wandersman, 1978)
A 17 item measure assessing parental competence on two dimensions: satisfaction with the parenting role and feelings of efficacy as a parent. This also has good internal consistency and test-retest reliability. This measure takes approximately 5 minutes to complete
Measured: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
Change in child's emotional wellbeing and behavioural difficulties from baseline as measured by Strengths and Difficulties Questionnaire (SDQ: Goodman, 1997)
a brief behavioural screening questionnaire about 3-16 year olds. Parents are asked 25 questions about their child, which are divided between 5 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviour. Parents rate each item as "not true", "somewhat true", and "always true" of their child. This measure has very good psychometric properties and is used as a routine child wellbeing outcome measure in many child mental health teams in the UK.
Measured: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
Change in parent emotional wellbeing from baseline as measured by The Depression, Anxiety and Stress Scale - 21 item version (DASS-21)
a 21 item self-report Questionnaire designed to measure the severity of a range of symptoms common to both Depression and Anxiety. Parents rate their responses to each item on a 4 point Likert scale from "never" to "almost always". The reliability and validity of this measure is very good, with internal consistency and validity being scored in the acceptable to excellent ranges
Measured: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emma Wells
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Emma Wells, University of Manchester
- Investigators
- Rachel Calam, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501369
- Sponsor's protocol ID
- 15059
- Status last verified
- Oct 2016
- First submitted
- 8 May 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
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
- 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
- ClinicalTrials.gov ID
- NCT02501369
- Acronym / sponsor ID
- 15059
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Emma WellsUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Jul 2015 (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.
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.
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-directed Teen Triple P | Experimental | Behavioral: Self-directed Teen Triple PSelf-directed Teen Triple P is a behaviourally based parenting intervention that parents follow at home using a workbook. It is based upon social learning theory principles and is used to help parents build upon their existing skills and information to practice positive parenting. Key skills promoted include: Increasing positive parent-teenager interactions, increase desirable behaviour, teach new behaviours and skills, and manage problem behaviour. As this is a case series design participants will act as their own controls and so there are no other arms to the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parents of adolescents (aged 11 to 16) with Cystic Fibrosis.
- Self reported difficulties with their child's treatment adherence.
Key exclusion criteria (3 listed)
- 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
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 Teen Triple PManualised parenting programme that parents will complete at home. This involves reading weekly modules of the manual and completing small exercises to practice the skills taught. These include strategies to help build positive relationships between parent and child, helping parents to effectively manage challenging childhood behaviours, and providing parents with the skills to support their child's independence and independent management of their cystic fibrosis. | Behavioural | Self-directed Teen Triple P |
Primary outcome
Change in Treatment Adherence from baseline as measured by Treatment Adherence Questionnaire - Revised (Quittner et al., 2008)
Time frame: baseline, intervention weeks 1, 2,3,4,5,6,7,8,9,10, and 1 month follow up
consists of 12 items across four subscales corresponding to different domains of CF treatment regime. It asks about adherence to various elements of treatment in the last week. Answers are measured across a 6 point Likert scale ranging from "not at all" to "3 or more times a day". Internal consistency (α=.82-.84) and test-retest reliability (r's=.42-.57) have been examined. This measure takes a maximum of 5 minutes to complete.
Change in parenting skill and competence from baseline as measured by The Parenting Scale (PS; Arnold et al., 1993)
Time frame: baseline, intervention weeks 1, 2,3,4,5,6,7,8,9,10, and 1 month follow up
30 item questionnaire measuring parent discipline styles. It has adequate internal consistency, good test-retest reliability and reliably distinguishes between clinical and non-clinical samples. This measure takes approximately 10 minutes to complete.
4 secondary outcomes
Change in parent stress from baseline as measured by Pediatric Inventory for Parents: PIP (Streisand et al., 2001)
Time frame: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
Change in parent's sense of competence from baseline as measured by Parent Sense of Competency Scale (PSOC; Gibaud-Wallston & Wandersman, 1978)
Time frame: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
Change in child's emotional wellbeing and behavioural difficulties from baseline as measured by Strengths and Difficulties Questionnaire (SDQ: Goodman, 1997)
Time frame: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
Change in parent emotional wellbeing from baseline as measured by The Depression, Anxiety and Stress Scale - 21 item version (DASS-21)
Time frame: baseline,weeks 5 and 10 of intervention, and 1 month follow-up
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.
Rachel Calam, PhD principal investigator
University of Manchester
Questions about this trial
What is this clinical trial studying?
A study testing Self-directed Teen Triple P in people with Cystic Fibrosis, run by Emma Wells.
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 2 inclusion and 3 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.
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.
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 Treatment Adherence from baseline as measured by Treatment Adherence Questionnaire - Revised (Quittner et al., 2008) (time frame: baseline, intervention weeks 1, 2,3,4,5,6,7,8,9,10, and 1 month follow up). The study lists 2 primary outcomes in all. 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.