Mindfulness-based Arabic Guided Self-help for Parents of Children With Type 1 Diabetes: A Randomised Pilot Trial.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Mindfulness
Study Overview
Brief Summary
Kuwait ranks as the third country worldwide for the incidence of type 1 diabetes (T1D) with an incidence of 37.10 per 100,000 children. A systematic review revealed that anxiety and depression are common in parents of children with T1D . Despite the high incidence rate, only one study to date has examined the psychological impact of diabetes on parents of children with T1D in Kuwait. It was found that 50.8% of parents had elevated levels of anxiety and 46.7% had elevated levels of depression.
Recent research shows that mindfulness is associated with a range of positive outcomes as well as decreased psychological and emotional distress. The earlier A doctor of philosophy (PhD) study found that mindfulness explained large amount of variance in anxiety and depression in a sample of parents of children with T1D. Mindfulness is defined as "paying attention in a particular way, on purpose, in the present moment, and non-judgmentally". The model of mindful parenting can be taught and provided as an intervention to improve psychological outcomes in parents of children with long term health conditions.
In line with this idea, one study examined the effectiveness of a mindfulness-based intervention on perceived stress and psychological anxiety among parents of children with autism spectrum disorder (ASD) in Jordan. The results indicated a significant decrease in stress and psychological distress in the intervention group compared to the comparison group. In the present pilot study, we will extend this work by evaluating a guided self-help a mindfulness intervention that aims to increase mindfulness and reduce psychological distress in parents of children with T1D in Kuwait.
Detailed Description
Aims and objectives
The overall aim of this pilot study is to assess the feasibility and acceptability, as well as examine potential effectiveness (from baseline to the end of the intervention), of a self-help online mindfulness-based intervention for Arab parents of children with T1D.
The specific objectives are to:
- Assess the acceptability of a guided self-help intervention for Arab parents of children with T1D.
- Ensure recruitment, randomisation and intervention procedures are feasible.
- Assess time to complete the intervention, for example whether it is feasible for parents to practice mindfulness (10-20 mins) and answer the log sheet daily.
- Evaluate the ability of the proposed outcome measures (anxiety, depression and mindfulness) to identify change when comparing the mindfulness group to the wait-list control group.
Hypotheses
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants will comprise Kuwaiti parents of children with type 1 diabetes with elevated levels of psychological distress (anxiety or/and depression) who participated in a previous study as part of the PhD research.
- •Inclusion criteria
- •Participants included in this study must be:
- •Kuwaiti parents of children diagnosed with T1D.
- •Children aged 15 and under.
- •Have Internet access.
- •Arabic speakers.
Exclusion Criteria
- •Participants will be excluded from the study if they are:
- •Parents of children diagnosed with type 2 diabetes (T2D).
Arms & Interventions
Intervention group
The intervention group will be asked to complete the outcomes measures anxiety, depression and mindfulness questionnaires at baseline, a week before the start of the intervention and at the end of the intervention time period(i.e., after five weeks).
Intervention: A human-interventional study (Behavioral)
Control group
The control group will be asked to complete the outcomes measures anxiety, depression and mindfulness questionnaires at baseline, a week before the start of the intervention and at the end of the intervention after six weeks.
At the end of the pilot trial, control group will receive the full intervention. They would be sent the materials week by week as same as the intervention group.
Intervention: A human-interventional study (Behavioral)
Outcomes
Primary Outcomes
Mindfulness
Time Frame: 10 minutes
Trait mindfulness will be measured by the the five-facet mindfulness questionnaire short-form (FFMQ-SF). This has 24 questions, which assess the five facets of mindfulness (observing, describing, acting with awareness, nonjudging and nonreacting). The FFMQ-SF is a reliable and valid measure: observing (α =. 81), describing (α =. 87), acting with awareness (α =. 83), non-judging (α =. 83) and non-reacting (α =. 75). The Mindfulness questionnaire has been translated into Arabic.
Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: 3 minutes
The GAD-7 is a widely used measure to assess anxiety; seven items have excellent reliability (α = .92) and validity. Items are rated at 4-point scales to produce a total score that can range from 0 to 21.GAD has been translated into Arabic
The Patient Health Questionnaire (PHQ-9).
Time Frame: 3 minutes
The PHQ-9 has a good reliability (α= .89). It is based on the diagnostic and statistical manual of mental disorders (DSM-IV) criteria for depression disorder. The measure contains 9 items rated on 4-point response scales. Scores can range from 0 to 27. PHQ has been translated into Arabic.
Secondary Outcomes
No secondary outcomes reported
Investigators
SHAHAH ALTAMMAR
PhD Student
University of Sheffield