The Effect of Motivational Interviewing in Children With Type 1 Diabetes

NCT06424574 | Completed

• 1 other identifier: DBAYKAL1421
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Motivational Interviewing; Type 1 Diabetes; Hypoglycemia; Fatigue; Self-Compassion

Outcome Measures

Primary Outcomes (4)

• The effect of motivational interviewing on parents' fear of hyperglycaemia Diabetes-Specific Self-Compassion Scale SCS-(Dp)

  University of Virginia Parental Fear of Low Blood Sugar Scale (P-LBSS)" It was developed by Gonder-Frederick and colleagues to assess parents' fear of their children's HG . The scale is a 4-point Likert-type scale consisting of 25 questions and two subscales (behavior, anxiety). Scoring on the scale is between 0 and 100, and the higher the score obtained from the scale, the higher the rate of HG fear increase. The Cronbach alpha reliability coefficients of the original scale were found to be 0.89, 0.76, and 0.91 for the total scale, behavior subscale, and anxiety subscale, respectively.

  13 monts

• The effect of motivational interviewing on parents' caregiving effects

  "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.The scale consists of a total of 15 items and shows positive and negative effects. The scale is a Likert-type scale, scored from +3 (in the best direction) to -3 (in the worst direction), ranging from 1 to 7. 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; the highest score is 10. As the scores increase, they are interpreted as ''change in the good direction'', and as the scores decrease, they are interpreted as ''change in the bad direction''. The internal consistency number of the original scale was found as 0.90, and the test-retest reliability was found as 0.81.

  13 months

• The effect of motivational interviewing on parents' fatigue severity

  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

  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

Study Arms (2)

Motivational interviewing

EXPERIMENTAL

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.

Behavioral: motivational interview

Standard care

NO INTERVENTION

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)

Interventions

motivational interview BEHAVIORAL

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.

Also known as: Experimental

Motivational interviewing

Eligibility Criteria

• Age: 2 Years - 18 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van YUZUNCU YIL UNIVERSITY

Van, 65100, Turkey (Türkiye)

Location

Related Publications (3)

• 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

• Channon S, Smith VJ, Gregory JW. A pilot study of motivational interviewing in adolescents with diabetes. Arch Dis Child. 2003 Aug;88(8):680-3. doi: 10.1136/adc.88.8.680.

  PMID: 12876161 BACKGROUND

• Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. doi: 10.2337/dc06-2260. Epub 2007 Mar 10.

  PMID: 17351283 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Fatigue

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dilek ÇİFTCİ BAYKA

  Yuzuncu Yil University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start: July 26, 2021
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)