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PRISM for Adolescents With Type 1 Diabetes

The Promoting Resilience in Stress Management (PRISM) Intervention: a Multisite Randomized Control Trial in Adolescents With Type 1 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03847194
Enrollment
172
Registered
2019-02-20
Start date
2020-01-01
Completion date
2024-03-31
Last updated
2024-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Brief summary

It is well-known that adolescents with type 1 diabetes are at high risk for elevated diabetes-specific distress and poor glycemic control. This randomized controlled trial uses a novel, person-centered intervention designed to reduce diabetes distress and improve resilience skills, which the investigators hypothesize will in turn improve glycemic control and quality of life. If successful, results will greatly inform future research and clinical strategies aimed at improving outcomes among adolescents with type 1 diabetes.

Detailed description

Adolescents with type 1 diabetes (T1D) are at high risk for elevated diabetes distress, which greatly impacts their adherence, glycemic control (A1C), and overall quality of life (QOL). A potential barrier to improving these experiences may be that adolescents have few opportunities to develop the personal resources needed to handle adversity and manage stress. The Promoting Resilience in Stress Management (PRISM) intervention is a manualized, brief, skills-based intervention delivered in 2, 45-60 minute one-on-one sessions, followed by a family meeting and supplemented by booster sessions and a digital app. PRISM was developed from Stress and Coping theory and targets skills in stress-management and mindfulness, goal-setting, positive reframing, and meaning-making. All of these skills are associated with improved patient outcomes in diverse groups of adolescent populations with chronic/serious illness, and findings from a feasibility trial in adolescents with T1D showed PRISM to be highly feasible and desirable in this population. Further, a recent pilot randomized controlled trial among adolescents with cancer suggest PRISM is associated with improved perceptions of resilience, lower psychological distress, and higher QOL. This application proposes to build on our prior experience and fill three critical knowledge gaps: (1) PRISM's impact on A1C among adolescents with T1D; and (2) PRISM's impact on diabetes distress, self-reported adherence, and other patient-reported outcomes including resilience and QOL. This funding opportunity seeks to test interventions targeting diabetes distress for impact on glycemic control. Thus, the investigators propose a multi-site randomized controlled trial among N=160 adolescents (n=80 PRISM, n=80 Usual Care; ages 13-18) with the primary trial outcome of glycemic control 6-months post-enrollment. Time-in-range will be evaluated for participants on continuous glucose monitors as an exploratory aim. Secondary outcomes will include diabetes-distress, and patient-reported adherence, resilience, and quality of life. The investigators hypothesize PRISM will promote better glycemic control and improved diabetes distress than usual care. This application offers an opportunity to expand the body of knowledge regarding methodologically rigorous and evidence-based interventions for adolescents with T1D. Ultimately, this research has the potential to offer a practical, skills-based curriculum designed to improve outcomes for this high-risk group.

Interventions

PRISM was developed based on stress and coping theory to be a brief, disease non-specific, skills-based intervention targeting adolescent resilience resources. PRISM teaches 4 pillars of resilience including stress management, goal setting, cognitive restructuring and benefit-finding in a one-on-one training program consisting of two, 45-60 minute sessions and supported by 6-months of booster sessions and a fully developed digital app for practice and tracking. A family session follows the individual sessions and was designed for the adolescent to communicate to his/her caregiver(s) the skills learned, and how the caregiver(s) could best support ongoing practice.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Seattle Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

randomized controlled trial with 2 groups: PRISM (intervention) arm or standard of care

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* • They are 13-18 years old * Diagnosed with T1D \>12 months * Elevated distress score (PAID-T\>=30)\*\*\*\*\* * Speak English fluently * Cognitively able to participate in intervention sessions and complete written surveys.

Exclusion criteria

* Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age * Cognitively or physically unable to participate * Patient unable to speak in the English language * Patient unable to read in the English or Spanish language * Adolescent is ward of state

Design outcomes

Primary

MeasureTime frameDescription
A1C6 monthshemoglobin A1C
Diabetes Distress6 monthsDiabetes distress will be measured with the Problem Areas in Diabetes Scale, Teen Version. Higher scores indicate more distress. Total score ranges from 6 to 84.

Secondary

MeasureTime frameDescription
Resilience6 monthsResilience will be measured with the Connor-Davidson Resilience Scale. Higher scores indicate more resilience. Total score ranges from 0-40.
Diabetes-specific Quality of Life6 monthsDiabetes-specific Quality of life will be measured using the adolescent self-report version of the Type 1 Diabetes and Life (T1DAL) which assesses diabetes-specific health-related quality of life (HRQOL) for people with type 1 diabetes (T1D). Higher scores indicate higher quality of life. Scale ranges 0-100, with higher scores indicating better quality of life.
Adherence6 monthsAdherence will be measured with the Diabetes Self-Management Questionnaire (DSMQ). The DSMQ ranges from 0-35 with higher scores indicate higher adherence.

Countries

United States

Participant flow

Pre-assignment details

Otherwise eligible patients need to score 30 or above on the Problem Areas in Diabetes validated scale, indicating moderate distress.

Participants by arm

ArmCount
PRISM Intervention Arm
The goal of the intervention is to teach resilience resource skills for use in current or future stressful situations. The total intervention consists of two, 45-60 minute, one-on-one sessions approximately 2-4 weeks apart followed by a family meeting discussing the skills learned. Following the family session through week 12, participants receive bi-weekly booster contacts (1:1 check-in sessions with the interventionist) to practice/refresh skills and check-ins on how skills have been utilized. These boosters will then be delivered monthly in months 4-6. In addition, all PRISM participants have access to the digital PRISM app, which offers an interactive practice and tracking interface to continue enhancing skills. Promoting Resilience in Stress Management (PRISM): PRISM was developed based on stress and coping theory to be a brief, disease non-specific, skills-based intervention targeting adolescent resilience resources. PRISM teaches 4 pillars of resilience including stress management, goal setting, cognitive restructuring and benefit-finding in a one-on-one training program consisting of two, 45-60 minute sessions and supported by 6-months of booster sessions and a fully developed digital app for practice and tracking. A family session follows the individual sessions and was designed for the adolescent to communicate to his/her caregiver(s) the skills learned, and how the caregiver(s) could best support ongoing practice.
85
Usual Care
Families in both randomization arms will receive usual medical care for diabetes, including psychosocial care provided by the mental health professionals affiliated with the diabetes clinic if needed. At both sites, every diabetes patient is cared for by a team of diabetes specialists which includes a provider (MD, Physician Assistant and/or Nurse Practitioner), dietician, and social worker. Subspecialty referrals for additional mental health or other support are made at the discretion of the primary diabetes provider.
87
Total172

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath01
Overall StudyLost to Follow-up25
Overall StudyWithdrawal by Subject12

Baseline characteristics

CharacteristicUsual CareTotalPRISM Intervention Arm
Age, Continuous15.7 years
STANDARD_DEVIATION 1.6
15.7 years
STANDARD_DEVIATION 1.6
15.7 years
STANDARD_DEVIATION 1.6
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants33 Participants22 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
76 Participants139 Participants63 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
HbA1C8.6 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 2.2
8.7 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 2.1
8.8 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.9
Insulin Pump use60 Participants115 Participants55 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Asian
4 Participants7 Participants3 Participants
Race (NIH/OMB)
Black or African American
15 Participants26 Participants11 Participants
Race (NIH/OMB)
More than one race
4 Participants10 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
62 Participants125 Participants63 Participants
Region of Enrollment
United States
87 participants172 participants85 participants
Sex/Gender, Customized
Female
52 Participants96 Participants44 Participants
Sex/Gender, Customized
Male
33 Participants68 Participants35 Participants
Sex/Gender, Customized
Other
2 Participants8 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 851 / 87
other
Total, other adverse events
0 / 850 / 87
serious
Total, serious adverse events
0 / 850 / 87

Outcome results

Primary

A1C

hemoglobin A1C

Time frame: 6 months

Population: intent to treat analysis

ArmMeasureValue (MEAN)Dispersion
PRISM Intervention ArmA1C8.7 percentage of glycosylated hemoglobinStandard Deviation 1.8
Usual CareA1C8.6 percentage of glycosylated hemoglobinStandard Deviation 1.8
Primary

Diabetes Distress

Diabetes distress will be measured with the Problem Areas in Diabetes Scale, Teen Version. Higher scores indicate more distress. Total score ranges from 6 to 84.

Time frame: 6 months

Population: Intent to treat

ArmMeasureValue (MEAN)Dispersion
PRISM Intervention ArmDiabetes Distress36.2 score on a scaleStandard Deviation 12.5
Usual CareDiabetes Distress39.9 score on a scaleStandard Deviation 15
Secondary

Adherence

Adherence will be measured with the Diabetes Self-Management Questionnaire (DSMQ). The DSMQ ranges from 0-35 with higher scores indicate higher adherence.

Time frame: 6 months

Population: intent to treat

ArmMeasureValue (MEAN)Dispersion
PRISM Intervention ArmAdherence19.9 score on a scaleStandard Deviation 7
Usual CareAdherence17.9 score on a scaleStandard Deviation 9.1
Secondary

Diabetes-specific Quality of Life

Diabetes-specific Quality of life will be measured using the adolescent self-report version of the Type 1 Diabetes and Life (T1DAL) which assesses diabetes-specific health-related quality of life (HRQOL) for people with type 1 diabetes (T1D). Higher scores indicate higher quality of life. Scale ranges 0-100, with higher scores indicating better quality of life.

Time frame: 6 months

Population: intent to treat

ArmMeasureValue (MEAN)Dispersion
PRISM Intervention ArmDiabetes-specific Quality of Life56.9 score on a scaleStandard Deviation 15.4
Usual CareDiabetes-specific Quality of Life53.5 score on a scaleStandard Deviation 15
Secondary

Resilience

Resilience will be measured with the Connor-Davidson Resilience Scale. Higher scores indicate more resilience. Total score ranges from 0-40.

Time frame: 6 months

Population: intent to treat

ArmMeasureValue (MEAN)Dispersion
PRISM Intervention ArmResilience25.2 score on a scaleStandard Deviation 6.8
Usual CareResilience25.7 score on a scaleStandard Deviation 7.3

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026