Mindfulness-based Arabic Guided Self-help for Parents of Children With Type 1 Diabetes

NCT03358394 | Unknown DMC

• 1 other identifier: Reference Number 016511
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

• Generalized Anxiety Disorder Scale (GAD-7)

  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

  3 minutes

• The Patient Health Questionnaire (PHQ-9).

  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.

  3 minutes

• Mindfulness

  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.

  10 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

Behavioral: A human-interventional study

Control group

EXPERIMENTAL

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.

Behavioral: A human-interventional study

Interventions

A human-interventional study BEHAVIORAL

The intervention was developed by Ahmed et al. (2017) and was adapted by the investigators for parents of children with T1D. The researcher has received permission form the author to use the script but, not the audio recordings. As a result, we contacted Saab et al. (2016) to get the permission to use the Arabic audio recording of Mindfulness exercises (i.e., introduction to mindfulness practice and mindfulness breathing). The mindfulness script to be used in the current study is based on MBPT. In this study, we will be using the MBPT programme, but tailored to the needs of parents of children with T1D. One of the main changes in our study is that it will be delivered via the Internet. Participants in the original MBPT programme attended in-person sessions however, Rayan et al. (2016) delivered only the first two sessions in person and the rest via telephone

Control group; Intervention group

Eligibility Criteria

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

You may qualify if:

• Participants included in this study must be:
• Kuwaiti parents of children diagnosed with T1D.
• Children aged 15 and under.
• Have Internet access.
• Arabic speakers.

You may not qualify if:

• Participants will be excluded from the study if they are:
• Parents of children diagnosed with type 2 diabetes (T2D).

Sponsors & Collaborators

• SHAHAH ALTAMMAR: lead

Study Sites (1)

Shahah Altammar

Kuwait City, 0000, Kuwait

Location

Related Publications (13)

• Barnard K, Thomas S, Royle P, Noyes K, Waugh N. Fear of hypoglycaemia in parents of young children with type 1 diabetes: a systematic review. BMC Pediatr. 2010 Jul 15;10:50. doi: 10.1186/1471-2431-10-50.

  PMID: 20633252 BACKGROUND

• Al-Tammar, S., Norman, P., & Thompson, A. (2017). The Role of Mindfulness and Illness Pereceptions in Psychological Outcomes in Parents of Children with Diabetes. Paper presented at the 31st Annual Conference of the European Health Psychology Society, Padova, Italy.

  BACKGROUND

• Brown, K. W., Ryan, R. M., & Creswell, J. D. Addressing fundamental questions about mindfulness. Psychological Inquiry, 18, 272-28, 2007.

  BACKGROUND

• Hayes, S. C., Follette, V. M., & Linehan, M. M. (2011). Mindfulness and Acceptance: Expanding the Cognitive-Behavioral Tradition: Guilford Publications.

  BACKGROUND

• Piet J, Wurtzen H, Zachariae R. The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. J Consult Clin Psychol. 2012 Dec;80(6):1007-20. doi: 10.1037/a0028329. Epub 2012 May 7.

  PMID: 22563637 BACKGROUND

• Kabat-Zinn, J. (1994). Wherever you go, there you are: Mindfulness meditation in everyday life. New York: Hyperion.

  BACKGROUND

• Bögels, S. M., Hellemans, J., van Deursen, S., Römer, M., & van der Meulen, R. (2014). Mindful parenting in mental health care: effects on parental and child psychopathology, parental stress, parenting, coparenting, and marital functioning. Mindfulness, 5, 536-551. doi:10.1007/s12671-013-0209-7

  BACKGROUND

• Rayan A, Ahmad M. Effectiveness of mindfulness-based interventions on quality of life and positive reappraisal coping among parents of children with autism spectrum disorder. Res Dev Disabil. 2016 Aug;55:185-96. doi: 10.1016/j.ridd.2016.04.002. Epub 2016 Apr 22.

  PMID: 27107368 BACKGROUND

• Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

  PMID: 18183564 BACKGROUND

• Julious, S. A. (2005). Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics, 4(4), 287-291. doi:10.1002/pst.185

  BACKGROUND

• Ferraioli, S. J., & Harris, S. L. (2013). Comparative effects of mindfulness and skills-based parent training programs for parents of children with autism: feasibility and preliminary outcome data. Mindfulness, 4(2), 89-101.

  BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Bergomi, C., Tschacher, W., & Kupper, Z. (2013). The Assessment of Mindfulness with Self-Report Measures: Existing Scales and Open Issues. Mindfulness, 4(3), 191-202. doi:10.1007/s12671-012-0110-9

  BACKGROUND

Related Links

• International Diabetes Federation. (2015). IDF Diabetes Atlas.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• SHAHAH M ALTAMMAR, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 30, 2017
• Study Start: October 26, 2017
• Primary Completion: February 26, 2018
• Study Completion: May 16, 2018
• Last Updated: December 6, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)