## Protocol Section
### Identification Module
**NCT ID:** NCT06424574

**Brief Title:** The Effect of Motivational Interviewing in Children With Type 1 Diabetes

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

#### Organization Study ID Info
**ID:** DBAYKAL1421
#### Organization
**Class:** OTHER
**Full Name:** Yuzuncu Yıl University
### Status Module
#### Completion Date
**Date:** 2022-08-19

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-08-19

**Type:** ACTUAL

#### Start Date
**Date:** 2021-07-26

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yuzuncu Yıl University

#### Responsible Party

**Investigator Affiliation:** Yuzuncu Yıl University

**Investigator Full Name:** Dilek Çiftci Baykal

**Investigator Title:** assistant professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Motivational Interviewing

- Type 1 Diabetes

- Hypoglycemia

- Fatigue

- Self-Compassion

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 74

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: motivational interview

**Label:** Motivational interviewing

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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)

**Label:** Standard care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Motivational interviewing

**Description:** 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.

**Name:** motivational interview

**Other Names:**

- Experimental

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** "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

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

**Time Frame:** 13 monts

**Description:** "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".

**Measure:** The effect of motivational interviewing on parents' caregiving effects

**Time Frame:** 13 months

**Description:** 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".

**Measure:** The effect of motivational interviewing on parents' fatigue severity

**Time Frame:** 13 months

**Description:** 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

**Measure:** The effect of motivational interviewing on parents' level of self-compassion

**Time Frame:** 13 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Gender Based:** True

**Healthy Volunteers:** True

**Maximum Age:** 18 Years

**Minimum Age:** 2 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Van

**Country:** Turkey

**Facility:** Van YUZUNCU YIL UNIVERSITY

**Zip:** 65100

#### Overall Officials

**Official 1:**

**Affiliation:** Van yuzuncu yil university

**Name:** Dilek ÇİFTCİ BAYKA

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Type 1 Diabetes

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

- ID: M10053

- Name: Hypoglycemia

- Relevance: HIGH

- As Found: Hypoglycemia

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

- ID: D000007003

- Term: Hypoglycemia

### Misc Info Module

- Version Holder: 2024-05-31
