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Research Proposal Draft

Abi Kim, Gabrielle Frad, Astrid Perez, Mikayla Zimmermann, Sebastian Castanon

Department of Counseling and Family Sciences, Loma Linda University

COUN/MFAM 501 Research Tools and Methodology: Quantitative

Dr. Bryan Cafferky, PhD

May 8, 2025
 Research Proposal Draft

Children with chronic illness face multiple stressors, including difficulties

managing the condition. Not only may they experience physical challenges, but they are also at

risk for anxiety. Mental health services may be beneficial in supporting these populations. This

paper explores two interventions to support children with type 1 diabetes who may also

experience anxiety.

Problem Objective

The purpose of this research is to examine whether cognitive behavioral therapy (CBT) or

acceptance and commitment therapy (ACT) is more effective in reducing anxiety levels in

children aged 6 to 12 who have been diagnosed with type 1 diabetes. Children with medical

conditions are at risk of developing anxiety, which may negatively affect treatment and their

overall well-being. According to Silina (2021), symptoms of anxiety were more common in

adolescents with type 1 diabetes, and their parents also faced distress due to their condition. The

project aims to investigate which intervention is more beneficial in supporting this population

with anxiety.

Interventions

CBT is an evidence-based practice that supports individuals in identifying and navigating

negative thought patterns that impact healthy functioning (Xu et al., 2021). This intervention

helps develop coping skills to manage emotional distress in children with chronic illness (Douma

et al., 2019). On the other hand, ACT supports the acceptance of difficult situations, and the

emotions and thoughts connected to them rather than controlling them (Panton et al., 2025). ACT

also uses mindfulness techniques to help accomplish this. ACT can help children to accept their

diagnoses, such as type 1 diabetes and the challenges that come with it. Additionally, both CBT
and ACT may deliver effective interventions in managing anxiety in children with chronic

illnesses.

Specific Aims

This study aims to evaluate the effectiveness of CBT and ACT in reducing anxiety in

children aged 6 to 12 years old diagnosed with type 1 diabetes. The project will examine the

effectiveness of each intervention in addressing anxiety among this population and compare the

outcomes between the two approaches. The results will determine which intervention is more

beneficial for reducing anxiety symptoms. The results may support pediatric providers in

providing more appropriate mental health resources for children with chronic illnesses.

Expected Outcomes/Hypotheses

While both CBT and ACT may decrease anxiety symptoms in children with type 1

diabetes, CBT may demonstrate more effectiveness. According to van Steensel and Bögels

(2015), CBT has shown proven long-term results in reducing anxiety symptoms in children with

anxiety disorders. Since CBT targets maladaptive thought patterns, it may be more efficient in

reducing anxious thoughts and emotions than ACT.

Benefits of the Study

The results of this study may promote a more multidisciplinary approach, in which

medical and mental health providers collaborate to improve overall health outcomes for children

with chronic illness and anxiety. Additionally, children who learn to manage anxiety symptoms

can improve adherence to treatment and help them feel more in control of their feelings and

health. Ultimately, this research will improve the quality of life for this population.
 Literature Review

The Significance of the Issue

Type 1 diabetes affects around 300,000 children in the U.S. population (Centers for

Disease Control and Prevention, 2021). The literature has found that children with chronic illness

are more susceptible to experiencing anxiety. Silina (2021) found that 13 percent of adolescents

with type 1 diabetes had severe anxiety compared to the group with no diagnoses. Adolescents

dealing with life transitions, on top of being diagnosed with a chronic illness, can cause stress

within the child and the family system. Our research aims to find out if Cognitive Behavioral

Therapy or Acceptance and Commitment Therapy can decrease anxiety in children (6-12 years

old) with type 1 diabetes.

Current Research

Parents also suffer with psychological distress when their child is chronically ill, which

demonstrates it does not only affect the patient but those around them (Thomas et al. 2024).

When dealing with the distress of their child's illness, the parents of the child will inevitably feel

a sense of despair, which in turn can make it difficult for them to cope with said struggles. This

research will continue to look into how this impacts friends, family, and loved ones dealing with

these predicaments.

Theory explaining Phenomenon

In the research by Anderson and Stanger (2023), the study examined the prevalence of

anxiety and depression symptoms in adolescents with type 1 diabetes and how that impacts

managing medications.The research used the Yerkes-Dodson Law, which says that higher levels

of emotional arousal can impair behavioral functioning (Yerkes & Dodson, 1908). In children

with diabetes the level of external and internal stress from having to follow a strict medication
schedule can be overwhelming and may lead to decreased medical compliance and increased

anxiety. In our study, the Yerkes-Dodson Law can be applied to how children with type 1

diabetes have an increase in anxiety symptoms.

Information about Intervention

CBT is an evidence-based practice that supports individuals in identifying and navigating

negative thought patterns that impact healthy functioning (Xu et al., 2021)The research shows

CBT techniques can be tailored to children, increasing positive outcomes in reducing

anxiety symptoms. Schoneveld et al. (2018) found that a video game that incorporated CBT,

helped

Children 7-12, decrease anxiety. CBT is versatile as it can be used across different ages and

platforms. Palermo et al. (2016) stated that CBT can also be used online, making it cost effective.

On the other hand, ACT supports the acceptance of difficult situations, and the emotions and

thoughts connected to them, rather than controlling them (Panton et al., 2025). In children with

chronic illness, anxiety and emotions tend to be affected negatively. CBT and ACT have been

found to help decrease anxiety, which is our targeted outcome for our research with type 1

diabetes.

Intervention Connect with Theory and the Issue

Research on both ACT and CBT has demonstrated their effectiveness in managing anxiety

and supporting medical adherence. These findings provide experimental support for concerns

raised by Anderson & Stanger (2023) and the Yerkes-Dodson Law, which suggests that elevated

anxiety can impair diabetes management. For example, Xu et al. (2020) found that group CBT

significantly reduced stress and improved psychological well-being and diabetes-related

outcomes. Similarly, Alho et al. (2022) showed that ACT can reduce anxiety and enhance mental
and physical health by increasing psychological flexibility. These results highlight the potential of

targeted psychological interventions to address emotional arousal and stress, ultimately improving

adolescent diabetes management. Overall, the evidence from studies on ACT and CBT aligns

with our theoretical framework, reinforcing that managing psychological stress is central to

effective diabetes care throughout the lifespan, with interventions like CBT playing a crucial role.

Gaps and Next Steps

The literature has many directions for research to explore to fill in the gaps in the

knowledge surrounding children ages 6 to 12 years old with type 1 diabetes. In Anderson and

Stanger (2023), the authors studied the effects of delayed discounting and anxiety/depression on

children with type 1 diabetes. However, there are areas for further exploration. In the future

implications section of the research, the authors discuss how future research should explore

interventions that will decrease symptoms of anxiety and depression in children with type 1

diabetes. This gap in the research is where we want to start our research hypothesis and find

interventions that lower levels of anxiety in adolescents ages (6-12) with type 1 diabetes. In

another article by Yao, Zhang, Du, & Gao (2021) the study looked at improving psychological

resilience in adult patients with type 2 diabetes. Although this research looks at the improvement

of psychological resilience, there is a need for studying how children with type 1 diabetes

improve when psychological symptoms, such as anxiety, are manipulated. In our research we aim

to fill in the gaps in the knowledge around children (6-12 years-old) with type 1 diabetes who

may benefit from treatment (CBT or ACT) in order to lower levels of anxiety.

Subjects of a Study

The subjects for this study will be adolescents aged 11 to 17 years who have been

diagnosed with type 1 diabetes (T1D). We plan to recruit between 150 to 200 participants, aiming
for a balanced representation of genders and diverse socioeconomic and ethnic backgrounds. This

age range is chosen because anxiety is highly prevalent and clinically significant among

adolescents with T1D, with studies such as Anderson and Stanger (2023) which found that

anxiety and depression in adolescents can impact managing medications.

Our sampling strategy will primarily use convenience sampling from pediatric diabetes

clinics, enhanced by outreach through community organizations and support groups to maximize

diversity and representation. Recruitment will involve collaboration with clinic staff to identify

eligible participants during routine diabetes visits, as well as the use of flyers and digital outreach

to families engaged in diabetes care. Inclusion criteria are: adolescents aged 11-17 years, a

diagnosis of type 1 diabetes, ability to provide assent (with parental consent), and fluency in the

language used for the study. Exclusion criteria include intellectual disabilities that would prevent

participation in the interventions, active psychosis or bipolar disorder, acute suicidality, and

current participation in other mental health intervention trials.

This sample is ideal for our study because adolescents with type 1 diabetes are vulnerable

to anxiety, which can negatively affect both their mental well-being and how they manage their

medication. This stage of life often comes with increased pressure to take care of themselves,

along with social and academic stress, making them more likely to experience emotional

struggles. By recruiting 150 to 200 participants from a variety of backgrounds through clinics

and community outreach, we aim to create a sample that is both large enough to provide reliable

data and diverse enough to reflect the broader adolescent diabetes population. This will help us

clearly compare the effects of CBT and ACT interventions and apply what we learn to real-world

care. Ultimately, this study can fill an important gap in current research and help shape how

mental health is incorporated into diabetes treatment for adolescents.

This study is designed as a double blind cohort study. Only one researcher will know

which group is receiving which form of treatment. The SCARED assessment will be used at the

beginning of the study and then again at the end of the study. SCARED is similar to the GAD-7,

but has been adapted for adolescents. In using this measure, we will be able to test anxiety levels

of the child pre- and post-treatment. If the child scores greater than or equal to 25 on the test, they

may fit the qualifications for multiple anxiety diagnoses. This measure was used in a study

written by Beherens et al. (2018), screening for child anxiety-related emotional disorders.

Data Collection

Our research study will use the SCARED Screening tool for Anxiety before treatment and

post-treatment. The SCARED assessment is administered on a password-protected webpage

before the first intervention. The results are then collected without any names or identification,

and the online program will send them to the researcher’s professional email. The results will then

be transferred to a file labeled either group 1 or group 2. After the six-month period is over and

the groups have completed their online intervention, they will complete the post-treatment

assessment, and it will be forwarded to the researcher’s email. Then, the researchers will input the

data from the two assessments into a spreadsheet in a secure database that will be analyzed later.

After collecting data, it needs to be stored in a HIPAA-compliant file, either online or in a

physical format. For this research, we would use a password-protected file that keeps the data

behind an encrypted lock. One method of data storing would be using a OneDrive file that can be

password protected and then locked on the researcher’s office computer. To ensure the data is

protected, the OneDrive can only be accessed on the researcher’s computer at the site of the study.
The assessments will be stored on the secure drive for the remainder of the study. The best

practice states that participants ’information can be stored up to seven years after the research has

concluded, which we will then erase after the time has elapsed.

First, participants will be given informed consent, and a researcher will discuss with them

that we will keep their information private and that they have the right to stop participating in the

study. Second, after the research has concluded, the data will be kept in an electronic file that is

password protected on a computer that is also locked by a password. Another way the data will be

kept confidential is that we will run a double blind study where the participants and researchers

don’t know which group will be given treatment. One researcher will know which groups received

which treatment and will provide the data to the researchers to collect and input into a database,

like OneDrive, for analysis. Each group will receive the same questionnaire pre- and post-

treatment and their assessments will be labeled group 1 or group 2. Participants' information will

not be filled out during the assessment to ensure confidentiality.

Proposed Analysis

The study will have a mixed-methods analytical approach to evaluate the overall

comparative effectiveness of both Cognitive Behavioral Therapy (CBT) and Acceptance and

Commitment Therapy (ACT), we will look over the interventions used for reducing anxiety in

children with type 1 diabetes. Given that children with medical conditions are at heightened risk

for developing anxiety that may negatively affect treatment adherence and overall well-being, this

analysis will provide critical insights into optimal psychological support strategies.
 Potential Limitations

The main limitations of this study include possible small sample size limiting statistical

power, the overall self-reporting challenges with younger children who may struggle to articulate

their feelings, and finally the potential therapist bias since ACT is newer for pediatric populations

compared to the more established CBT. One other limitation is therapist bias, as this could

influence intervention delivery since ACT is relatively newer for pediatric populations compared

to the more established CBT approach, possibly creating an uneven implementation that might

skew comparative results.

Benefits and General Applicability

This study certainly has some major benefits for both clinical practice and research.

Finding out whether CBT or ACT works better for kids with type 1 diabetes who have anxiety

means doctors can actually use treatments that are proven to work. This approach isn't just useful

for diabetes - it could help kids with all kinds of chronic conditions where anxiety is an issue. The

results could help create an overall standard way to screen for mental health problems in pediatric

diabetes clinics, which might improve both psychological health and how well kids stick to their

diabetes management. Plus, if these interventions work well, they could save money on healthcare

costs by preventing many anxiety-related complications and hospital stays. Overall, this research

shows how important it is to treat both the physical and mental aspects of chronic illness in

children.

Conclusion

Our research aims to fill a very important gap by comparing CBT and ACT to see which

works better for reducing anxiety in children with type 1 diabetes. After combining our efforts

together, we as a team managed to construct a solid thesis that can help aid us in our actual
research methods. The study uses a mixed-methods approach to give us a clear picture of how

these interventions affect anxiety levels in this population. We know there are some limitations,

like the potential for a small sample size and the challenge of younger kids accurately reporting

their feelings. Despite these issues, the benefits of this research are significant. Finding the most

effective intervention will directly help pediatric diabetes care by giving providers evidence for

which therapy to recommend. This research is a step toward treating the child as a whole, rather

than strictly focusing on their debilitating illness. Since the weight of anxiety can make it harder

for children to manage their diabetes and affect their quality of life, our study could help improve

both their mental health and their physical health outcomes. Overall, this research will contribute

to better care for children with type 1 diabetes by addressing both their medical and psychological

needs.

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10.1002/cne.920180503