INTRODUCTION
Childhood is one of the most important periods of life, serving as the cornerstone for lifelong mental health and well-being.[1] Chronic diseases in children can increase the risk of psychological problems like depression and anxiety.[2] T1D is one of the most common endocrine disorders in children with an increasing incidence trend globally, particularly in developing countries.[3,4] It can greatly impact children’s quality of life, leading to emotional and physical obstacles.[5,6]
Cognitive factors significantly influence the emotional impact of childhood illnesses.[7] Affects, both positive and negative, are important in managing and regulating diabetes.[8,9] Positive can help individuals respond better to challenges and cope more effectively with stress, including chronic diseases like diabetes. On the other hand, many patients with diabetes experience negative affect reactions such as sadness, denial, anger, doubt, mistrust, depression, and withdrawal. These emotional responses can worsen diabetes complications and reduce the quality of life, especially in children who are particularly vulnerable to mood and anxiety disorders after being diagnosed with diabetes.[10–13]
Research has shown that individuals with diabetes often struggle to recognize their emotions.[14] Emotional awareness, involving the identification of one’s own and others’ emotions, improves adaptability and effective management of consequences. Those with lower emotional awareness tend to focus on thoughts and bodily sensations rather than using specific emotional terms. Therefore, emotion regulation skills are crucial for preventive interventions and psychological treatments in addressing various physical and psychological issues.[14–19]
Recent research has emphasized the effectiveness of unified protocols for transdiagnostic treatment in children, particularly those with T1D.[20,21] This approach improves quality of life, reduces depression and anxiety in children, and enhances emotional regulation in their mothers. Transdiagnostic interventions, targeting common underlying mechanisms in emotional disorders are used, such as Unified protocols for transdiagnostic treatment drawing from cognitive-behavioral therapy principles. This integrated approach is preferred for children and adolescents as it addresses underlying issues that may contribute to emotional disorders.[22–24]
In addition to integrated unified protocols for transdiagnostic treatment for children with T1D, cognitive-behavioral therapy addresses maladaptive thoughts and behaviors resulting from ineffective coping strategies.[25] While effective in addressing cognitive distortions and emotional fluctuations, cognitive-behavioral therapy has shown issues with sustained benefits post-treatment.[26] To address this, a modular cognitive-behavioral therapy approach has been developed, emphasizing core strategies targeting behavioral, emotional, and cognitive tendencies common to anxiety disorders. This treatment involves creating a fear hierarchy, anxiety management training, exposure exercises, and skill maintenance training for children.[26–28]
This research underscores the psychological impact of T1D on children and the need to address socio-psychological issues and maladaptive behaviors through tailored interventions, ultimately improving their quality of life.[29,30] Given the increasing trend of T1D, the age-specific characteristics of children, the chronicity of diabetes, and societal and familial perspectives on the condition and affected individuals, this study aims to develop strategies for the psychological and emotional needs of diabetic children aged 8–12 by evaluating the effectiveness of unified protocols for transdiagnostic treatment and modular cognitive-behavioral therapy. The goal is to enhance the quality of care and positively impact emotional regulation and physical well-being, specifically investigating the effectiveness of these therapies on the and emotional awareness of children with T1D.
MATERIALS AND METHODS
This was a quasi-experimental study of pre-test and post-test with a control group and a two-month follow-up period. We included children aged 8–12 years, with T1D who were referred from the clinics of pediatric endocrinologists from August 2022 to March 2023. After the announcement, 45 children with T1D were selected from clinic referrals and randomly assigned to two experimental groups and one control group, with 15 patients in each group.
T1D patients with acute or chronic psychological disorders or a history of psychological treatments were not included. Non-cooperative children, those who fail to complete assigned tasks and miss more than two sessions, were excluded.
Before the intervention, parents’ consent was obtained for their child’s participation in the study, and parents and participants were informed that their information remained confidential and that they could withdraw from the study whenever they were not willing to continue participating in the study. This research has been approved ethically by the Research Ethics Committee of Isfahan Islamic Azad University (Khorasgan).
Study population
To carry out the research, 45 participants were randomly assigned to two experimental groups and one control group (15 people in each group). All participants completed the Positive and Negative Affect Schedule for Children (PANAS, 1999)[31] and the Emotional Awareness Questionnaire (EAQ-30).[32] The experimental groups attended the 10 sessions of 60 minutes with the children and 30 minutes with the mothers, weekly and in parallel modular cognitive-behavioral therapy of the processing unit. The control group did not receive any intervention during this period and was on the waiting list. The unified protocols for transdiagnostic treatment, following Ehrenreich’s protocol,[33] were delivered as group sessions resembling training classes for the participants in the first experimental group [Appendix 1]. Similarly, the modular cognitive-behavioral therapy based on Churpita’s therapeutic protocol[34] was administered as group sessions akin to training classes for the participants in the second experimental group [Appendix 2]. Following the treatment sessions, all three groups underwent a post-test assessment, and a follow-up session was scheduled two months later, during which participants from all groups completed the same questionnaire items as in the initial stage.
Data collection tools
Positive and negative affect scale for children (Panas, 1999)
This self-assessment tool comprises 27 items and was developed by Laurent et al.[31] It is an adaptation of the PANAS scale originally designed for adults. The scale includes 12 items measuring positive affect and 15 items measuring negative affect, rated on a five-point Likert scale ranging from 1 (very little) to 5 (very much). The internal consistency, measured by Cronbach’s alpha coefficient, for the positive affect subscale, was 0.94 in the preliminary questionnaire design sample and 0.92 in the main study sample by Laurent et al.,[31] while for the negative affect, it was 0.90 and 0.89, respectively. In Iran, Lotfi et al.[35] assessed the validity and reliability of this questionnaire, reporting a Cronbach’s alpha coefficient of 0.85 for internal consistency. Significant correlations were found between positive and negative affect and repression strategies, symptoms of anxiety disorders (intellectual-pragmatic dichotomy), and depression. In the current study, Cronbach’s alpha coefficients for positive and negative affect were 0.98and0.94, respectively, and the test–retest reliability coefficients were 0.980 and 0.989, respectively.
Emotional Awareness Questionnaire (EAQ-30)
The Emotional Awareness Questionnaire, developed by Rieffe et al.,[32] was adapted from the Toronto Emotional Dysfunction Scale (Bagby et al., 1994)[36] to gauge children’s and adolescents’ perception and understanding of their emotions. Comprising six subscales, this questionnaire assesses the ability to differentiate between emotions (7 questions), express emotions (3 questions), refrain from concealing emotions (5 questions), physical self-awareness (5 questions), attentiveness to others’ emotions (5 questions), and analytical skills in processing emotions (5 questions). Rieffe et al.[37] validated this questionnaire on 706 Dutch children and adolescents, yielding reliability coefficients ranging from 0.64 to 0.68 for the various subscales. The authors also confirmed the six-factor structure through factor analysis. In an Iranian study by Gholamreza and Saberi, the questionnaire’s validity and reliability were assessed, resulting in a Cronbach’s alpha coefficient of 0.78 for the entire questionnaire. Both exploratory and confirmatory factor analyses supported the questionnaire’s six-factor structure.[38] Additionally, in the current study, the Cronbach’s alpha coefficient was0.82, indicating high internal consistency. Test–retest reliability in the present study was found to be 0.997, indicating excellent stability over time.
Statistical analysis
The data were analyzed using repeated measures analysis of variance in the IBM SPSS-23 software (SPSS Inc., Chicago, IL, USA). Student t-test and Chi-square test were used to compare the mean of quantitative [presented as means ± standard deviation (SD)] and qualitative [presented as number (%)] variables, respectively. Analysis of variance (ANOVA) was used for testing the significance levels between the different groups, and ANOVA for repeated measures was used to test significance levels between the measurement times. Data were analyzed by comparing patients in the three studied groups. P value < 0.05 was considered to be statistically significant.
RESULTS
In this research, 45 children with T1D were studied in three groups (15 in each group) Figure 1. The baseline characteristics of the patients in the three groups are presented in Table 1. The participants in the three groups were similar regarding their age, sex distribution, and disease characteristics (P > 0.05).
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Figure 1: CONSORT flow chart of participants for recruitment, application, follow-up and analysis
Table 1: The baseline characteristics of children with type 1 diabetes in the Integrated Transdiagnostic Therapy, Cognitive-Behavioral Therapy and control groups
The mean (SD) of positive and negative and emotional awareness in the three studied groups during the pretest, post-test, and follow-up are presented in Table 2. Mean (SD) of positive and negative, and emotional awareness were significantly higher in the interventional groups than the control group (P < 0.05).
Table 2: The mean (SD) of Positive and Negative Emotions, and Emotional Awareness in the three studied groups during the pretest, post-test, and follow-up
The mean (SD) of positive affect, and emotional awareness increased significantly during the post-test and follow-up in the interventional groups than pretest (P < 0.05). The mean (SD) of negative affect decreased significantly during the post-test and follow-up in the interventional groups than the pretest (P < 0.05).
The results of Levene’s test for the studied variables were as follows:
For positive affect, the pre-test (sig = 0.195, F = 1.703), post-test (sig = 0.668, F = 0.408), and follow-up (sig = 0.771, F = 0.262) showed that the assumption of variance equality was met.
For negative affect, the pre-test (sig = 0.447, F = 0.822), post-test (sig = 0.262, F = 1.38), and follow-up (sig = 0.348, F = 0.081) also confirmed the assumption of variance equality.
For emotional awareness, the pre-test (sig = 0.394, F = 0.953), post-test (sig = 0.320, F = 0.171), and follow-up (sig = 0.063, F = 0.782) stages indicated that the assumption of variance equality was confirmed in all three variables at all three stages.
The results of Mauchly’s test to examine the sphericity assumption in groups were as follows:
For the positive variable (Mauchly’s W = 0.945, Chi-square = 14.2, sig = 0.342), the sphericity assumption was met.
For negative affect (Mauchly’s W = 0.797, Chi-square = 605.8, sig = 0.014), the sphericity assumption was violated, and therefore, the Greenhouse–Geisser correction was used.
For emotional awareness (Mauchly’s W = 0.925, Chi-square = 94.2, sig = 0.229), the sphericity assumption was met.
The results of repeated measures analysis of variance, for evaluating the differences within and between studied groups during the pretest, post-test, and follow-up, are presented in Table 3, Figure 2.
Figure 2: The results of repeated measures analysis of variance, for evaluating the differences within and between studied groups during the pretest, post-test, and follow-up for positive and negative affect and emotional-awareness
Table 3: The results of repeated measures analysis of variance, for evaluating the differences within and between studied groups during the pretest, post-test, and follow-up
The between-group analysis revealed significant differences in the mean scores of the following variables between the interventional groups and the control group:
Positive affect: F-value = 51.85, P < 0.001, η² = 0.811
Negative affect: F-value = 48.007, P < 0.001, η² = 0.711
Emotional awareness: F-value = 14.41, P < 0.001, η² = 0.425
The results also showed a significant main effect of time, indicating that there were significant overall differences in the mean scores of all three variables during the pretest, post-test, and follow-up stages as follows:
Positive affect: F-value = 218.19, P < 0.001, η² = 0.848
Negative affect: F-value = 134.204, P < 0.001, η² =0.775
Emotional awareness: F-value = 108.969, P < 0.001, η² = 0.736
Furthermore, the interaction effect of time and group was significant for all three variables, suggesting that the changes in pre-test, post-test, and follow-up stages were significant in each of the groups:
Positive affect: F-value = 52.77, P < 0.001, η² = 0.73
Negative affect: F-value = 38.83, P < 0.001, η² = 0.663
Emotional awareness: F-value = 28.64, P < 0.001, η² = 0.595
The percentage differences during the studied times in the groups were:
Positive and negative affect variables: 73% and 66%, respectively.
Emotional awareness: 59%.
The difference between the two experimental groups and the control group was statistically significant (P < 0.05) in both the post-test and follow-up stages for all three variables: positive affect, negative affect, and emotional awareness, as follows:
Positive Affect:
Unified protocols for transdiagnostic treatment: Post-test: 9.76% increase, Follow-up: 4.83% increase.
Modular cognitive-behavioral therapy: Post-test: 3.72% increase, Follow-up: 9.78% increase
Negative Affect:
Unified protocols for transdiagnostic treatment: Post-test: 5.66% decrease, Follow-up: 5.73% decrease.
Modular cognitive-behavioral therapy: Post-test: 4.77% decrease, Follow-up: 6.78% decrease.
Emotional Awareness:
Unified protocols for transdiagnostic treatment: Post-test: 5.6% increase, Follow-up: 7.51% increase.
Modular cognitive-behavioral therapy: Post-test: 4.8% increase, Follow-up: 4.38% increase.
Comparison of treatment methods
A significant difference was found between the two treatment groups only in the negative affect variable at post-test time (P < 0.05).
No significant difference was found between the two groups in positive affect and emotional awareness at post-test and follow-up times, as well as in negative affect at follow-up time (P > 0.05).
Based on the mean scores in Table 1, modular cognitive-behavioral therapy was more effective than unified protocols for transdiagnostic treatment in reducing negative affect at post-test.
The difference in mean scores of all three variables between the pre-test and post-test, as well as between the pre-test and follow-up, was significant (P < 0.05) in both groups. However, the difference in mean scores between the post-test and follow-up was not significant (P > 0.05) for any of the three variables in these groups. In both treatment groups, the mean scores in positive affect and emotional awareness increased compared to the pre-test in the post-test and follow-up stages, while the negative variable decreased but remained stable from the post-test to the follow-up stage.
DISCUSSION
In this research, we investigated the effects of unified protocols and modular cognitive-behavioral therapy on positive affect, negative affect, and emotional awareness in patients with T1D. Both therapies successfully increased positive affect and emotional awareness while decreasing negative affect. A comparison of the two methods showed that modular cognitive-behavioral therapy was more effective in reducing negative affect during the post-test phase.
Previous studies have demonstrated the efficacy of these intervention methods in alleviating negative and improving emotional awareness, especially among individuals with chronic illnesses.[39–42]
Poza and Detour’s study has examined the efficacy of modular cognitive-behavioral therapy in alleviating negative, such as depression and anxiety, in youth vulnerable to psychosis,[43] as well as in mitigating anxiety symptoms among Iranian adolescents.[44–46]
Children with T1D often experience psychological challenges, such as anxiety and negative effects, due to the demands of disease management.[47,48] Thus, implementing treatments that can positively impact their emotions is crucial.
The study found that both unified protocols for transdiagnostic therapy and modular cognitive-behavioral therapy were effective in reducing negative, enhancing emotional awareness, and increasing positive in patients with T1D. These findings align with prior research demonstrating the efficacy of such approaches, particularly modular cognitive-behavioral therapy, in improving emotional outcomes among individuals with chronic illnesses.[41]
In contrast to previous studies, this research found modular cognitive-behavioral therapy to be more effective than unified protocols for transdiagnostic therapy in diminishing negative among patients with T1D. This aligns with prior research demonstrating the substantial positive impact of modular cognitive-behavioral approaches on mitigating negative.[41] While modular cognitive-behavioral therapy is typically more effective in addressing negative, unified protocols for transdiagnostic therapy may yield greater enhancements in emotional awareness and positive, potentially better suited certain individuals.[49]
The findings align with Ghasemzadeh et al.,[20] who showed the unified protocol for transdiagnostic treatment improved quality of life, reduced depression and anxiety in children with T1D, and enhanced emotional regulation in mothers.[21]
When interpreting the results of this study, it becomes evident that the transdiagnostic therapy approach places significant emphasis on the role of emotions and strategies for regulating them in individuals. This approach underscores the centrality of emotional experiences in the treatment process, as it facilitates patients in acquiring essential skills for effectively managing negative affective states. By targeting emotional regulation, the transdiagnostic protocol enables patients to develop a greater capacity for adaptively responding to and coping with challenging emotional experiences. This holistic focus on emotions and their regulation is a key strength of the transdiagnostic treatment approach, as it addresses a core component of the lived experience for individuals dealing with various psychological and physical health concerns.[50]
Heightened emotional awareness enhances assessment of both positive and negative, boosting the child’s emotional intelligence and reducing negative while amplifying positive emotions. Expressing emotions and shared experiences, strengthened by empathy, develops the child’s emotional well-being.
Furthermore, when elucidating the findings, it can be observed that children with T1D, due to the nature of their condition and the resultant anxiety, may turn to overeating and neglect their treatment regimen, leading to uncontrolled diabetes. Although these avoidance behaviors provide temporary relief from disease-induced anxiety, they inadvertently reinforce the complications associated with the disease over time. This tailored psychological intervention aims to replace negative with positive ones, thereby fostering emotional resilience and diminishing negative in children with T1D. In explaining the results obtained regarding the effectiveness of modular cognitive-behavioral therapy on improving emotional awareness and emotions in children with T1D, it can be said that living with diabetes can cause sadness, worry, anger, disappointment, or stress.[51] Children with diabetes do not have an efficient strategy to get out of these emotions and negative Modular cognitive-behavioral therapy helps children to adopt more logical and accurate strategies to deal with negative. This therapy helps to identify the thoughts and reasons behind negative, and then by controlling emotions, the child can behave more efficiently.
Modular cognitive-behavioral therapy not only reduces negative affects but also enhances positive, promoting comfort in children with diabetes. It helps mitigate fears, tensions, and nervousness while bolstering resilience to confront depression and hopelessness, fostering contentment and trust. Cognitive restructuring techniques are used to mitigate negative thoughts, empowering children to take responsibility for behavioral changes and confront fearful stimuli through exposure. This tailored approach focuses on correcting negative thoughts and promoting engagement, facilitating adaptive and less avoidant coping.
Cognitive therapy encourages shifting perspectives on thoughts as transient mental events. This enables cognitive restructuring and optimistic thinking when catastrophic thoughts arise. Within this framework, the child and parent undergo a transformation in attitudes and beliefs about the disease. By fostering heightened emotional awareness, this treatment facilitates emotional improvement in the child.
Modular cognitive-behavioral therapy enhances emotional awareness and well-being in children with T1D by enabling cognitive shifts. These interventions empower individuals to reinterpret experiences from new perspectives, fostering self-awareness and a more comprehensive problem-solving approach.[52] By engaging both child and parent, the treatment aims to rectify misconceptions about the disease, mitigating negative.
Cognitive-behavioral approaches emphasize how cognition influences emotions and behaviors. These approaches posit that it’s not events, but interpretations, that lead to issues. Modular CBT contends that self-experiences shape behavior and beliefs. To drive lasting change, it’s crucial to address and alter beliefs. Within this framework, adjusting the attitudes and beliefs of both child and parent regarding the disease enhances the child’s emotional awareness and well-being, particularly regarding negative.
This study had limitations. It focused only on 8-12-year-old children with T1D from pediatric clinics. Caution is needed when applying the findings to other populations. The study’s short duration means long-term effects were not fully explored. Future research should examine different samples, including type 2 diabetes, to enable comparisons and expand understanding in this field.
CONCLUSION
Based on these findings, both interventions can be used as useful treatments to improve psychological variables in children with T1D. These results underscore its potential as a potent tool for enhancing the emotional well-being of individuals with this condition, thereby contributing to an improved quality of life.
The study emphasizes the need for careful evaluation of treatment options and highlights the necessity of having psychologists in pediatric endocrinology centers. This research can be used as a baseline guide for future studies and refine treatment strategies for children with T1D.
Integrating clinical psychologists into diabetes centers is recommended to implement the protocols for children and parents. Health authorities should establish standardized protocols mandating psychotherapeutic interventions, including unified protocols and modular cognitive-behavioral therapy, for affected families.
Ethics approval and consent to participate
The protocol of the study was approved by the ethics committee of Islamic Azad University (Khorasgan branch) With ethics code of IR.IAU.KHUISF.REC.1403.118.
Availability of data and materials
The datasets generated and/or analyzed during the current study are not publicly available due to privacy/ethical restrictions but are available from the corresponding author upon reasonable request.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
Acknowledgment
We would like to acknowledge all patients and their parents for their cooperation.
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Appendix 1 Description of unified protocols for transdiagnostic treatment sessions based on the Ehrenreich protocol (2018)
Appendix 2 Description of cognitive-behavioral treatment sessions based on Chorpita protocol (2007)
