Investigating the Use of a Positive Parenting Programme to Improve Treatment Adherence in Cystic Fibrosis

NCT02501369 | Completed

• 1 other identifier: 15059
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  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)

  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)

  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)

  baseline,weeks 5 and 10 of intervention, and 1 month follow-up

Other Outcomes (1)

• Parent satisfaction with the intervention at mid and end intervention points as measured by Client Satisfaction Questionnaire

  weeks 5 and 10 of intervention

Study Arms (1)

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.

Behavioral: Self-directed Teen Triple P

Interventions

Self-directed Teen Triple P BEHAVIORAL

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.

Self-directed Teen Triple P

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emma Wells: lead
• Manchester University NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Rachel Calam, PhD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: July 17, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10