The Effect of Motivational Interviewing in Children With Type 1 Diabetes

May 16, 2024 updated by: Dilek Çiftci Baykal, Yuzuncu Yıl University

The Effect of Motivational Interviewing on Hypoglycemia Fear Caring Failure and Self-commission in Parents of Children With Type 1 Diabetes

This research was conducted in a randomized controlled experimental way to determine the effect of motivational interviewing on hypoglycemia fear, caregiving, fatigue and self-compassion in parents of children with Type 1 diabetes. The research was conducted with the parents of the patients who came to the Pediatric Endocrinology polyclinic of the Van Training and Research Hospital of the University of Health Sciences between July 26, 2021 and August 19, 2022. The research was carried out in two stages. The first stage was carried out methodologically to determine the validity and reliability of the "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" in Turkish. The sample of the study was composed of 102 parents and the data were collected with the "Descriptive Information Form" and the " Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)". "Language", "scope" and "construct" validity analyzes were used to evaluate the validity of the scale. KMO and Bartlett's Tests and factor analysis were evaluated for construct validity. As a result of the reliability analysis the Cronbach Alpha coefficient of the scale was found to be 0.817. As a result it was seen that the two 19 item sub-dimensions of the Turkish form of the "Parental Version Of The Diabetes Specific Self-Compassion Scale SCS-(Dp)" were confirmed for the Turkish form in the same way. The sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used.

Study Overview

Detailed Description

This research was conducted in a randomized controlled experimental way to determine the effect of motivational interviewing on hypoglycemia fear, caregiving, fatigue and self-compassion in parents of children with Type 1 diabetes. The research was conducted with the parents of the patients who came to the Pediatric Endocrinology polyclinic of the Van Training and Research Hospital of the University of Health Sciences between July 26, 2021 and August 19, 2022. The research was carried out in two stages. The first stage was carried out methodologically to determine the validity and reliability of the "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" in Turkish. The sample of the study was composed of 102 parents and the data were collected with the "Descriptive Information Form" and the " Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)". "Language", "scope" and "construct" validity analyzes were used to evaluate the validity of the scale. KMO and Bartlett's Tests and factor analysis were evaluated for construct validity. As a result of the reliability analysis the Cronbach Alpha coefficient of the scale was found to be 0.817. As a result it was seen that the two 19 item sub-dimensions of the Turkish form of the "Parental Version Of The Diabetes Specific Self-Compassion Scale SCS-(Dp)" were confirmed for the Turkish form in the same way. The sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used.

The scales were applied at the beginning of the study and 10 weeks after the first data. After the first test data were obtained from each parent in our research group, four face-to-face motivational interviews were conducted at two-week intervals. In the interviews, attempts were made to change and improve the behaviors and skills that parents felt inadequate within the scope of fear of hypoglycemia, caregiving, fatigue and self-compassion.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Van, Turkey, 65100
        • Van Yuzuncu Yil University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • with a child diagnosed with T1D between the ages of 2-18 years,
  • Can read and write Turkish, can be reached and communicated with,
  • Orientation and co-operation,
  • Without hearing, understanding and vision problems,
  • Parents who agreed to participate in the study

Exclusion Criteria

  • Communication difficulties,
  • It is determined as being illiterate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motivational interviewing

I. Interview: -Research for parents information was given about. Pretest forms were applied.

Pre-test forms from filling;

  1. st interview after 2 weeks (45 min)
  2. nd interview after 2 weeks (45 min)
  3. Interviews after 2 weeks (45 min)
  4. th interview after 2 weeks (45 min)
  5. th interview: Post-test data were obtained 2 weeks after the last interview they were.
The sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used. The scales were applied at the beginning of the study and 10 weeks after the first data. After the first test data were obtained from each parent in our research group, four face-to-face motivational interviews were conducted at two-week intervals. In the xvii interviews, attempts were made to change and improve the behaviors and skills that parents felt inadequate within the scope of fear of hypoglycemia, caregiving, fatigue and self-compassion.
Other Names:
  • Experimental
No Intervention: Standard care

I. Interview: -Research for parents information was given about. Pretest forms were applied.

II interview: Post-test data were obtained 2 weeks after the last interview they were.

Post-test data were obtained 10 weeks after the last interview (it was ensured that the same time period passed with the experimental group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of motivational interviewing on parents' fear of hyperglycaemia Diabetes-Specific Self-Compassion Scale SCS-(Dp)
Time Frame: 13 monts
"Virginia Parent Low Blood Sugar Scale (P-LBSS)" It was developed by Gonder-Frederick and colleagues to assess parents' fear of their children's HG . The validity and reliability of the Turkish version of the scale was measured by Şen Celasin et al. in 2018. According to the results of the factor analysis, the p-LBSS scale in Turkish version has two sub-dimensions as in the original. The scale is a 4-point Likert-type scale consisting of 25 questions and two subscales (behaviour, anxiety). Scoring on the scale is between 0 and 100 and the higher the score on the scale, the higher the rate of increase in HG fear
13 monts
The effect of motivational interviewing on parents' caregiving effects
Time Frame: 13 months
"Bakas Caregiving Impact Scale" is a measurement tool developed by Bakas and colleagues in 1999 to evaluate how the experiences of caregivers change with the caregiving process (Bakas et al., 2006). The scale consists of a total of 15 items and shows positive and negative effects. The scale is a Likert-type scale ranging from 1 to 7, scored from +3 (for the best) to -3 (for the worst). Scoring is done as -3=1, -2=2, -1=3, 0=4, +1=5, +2=6, +3=7. The lowest score that can be obtained from the scale is 15 and the highest score is 10. As the scores increase, it is interpreted as "change for the better" and as the scores decrease, it is interpreted as "change for the worse".
13 months
The effect of motivational interviewing on parents' fatigue severity
Time Frame: 13 months

The Fatigue Severity Scale, which was also developed in the USA, was used for the first time in patients with multiple sclerosis.

was used. Turkish validity and reliability study of the scale It was conducted by Armutlu et al. in 2007. The scale has 9 questions and each question consists of 7 points. An increase in the scale score indicates an increase in the level of fatigue.

The scale determines the fatigue status of individuals in the last 1 month. The questions are scored as strongly disagree (1)- strongly agree (7). The scale score is the average value of the questions. If the average score is 4 and above, it is considered as "severe fatigue". The lower the total score, the less "fatigue".

13 months
The effect of motivational interviewing on parents' level of self-compassion
Time Frame: 13 months
The scale was developed by Tanenbaum et al. in 2020 to measure whether they have self-efficacy in coping with diabetes and coping with their emotions. The scale consists of 19 items and is a 5-point Likert-type scale (1="Almost never" and 5="Almost always"). Scale Positive dimension It has a two-factor structure as negative and negative dimension. The total score is calculated by averaging all items. Higher scores indicate higher diabetes-specific self-compassion
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Dilek ÇİFTCİ BAYKA, Van Yuzuncu Yil University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2021

Primary Completion (Actual)

August 19, 2022

Study Completion (Actual)

August 19, 2022

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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