NCT07822555

Brief Summary

The Diabetes \& Equine Empowerment Program (DEEP) is a research study evaluating a novel diabetes education program that combines hands-on interactions with miniature horses and evidence-based diabetes self-management education for youth ages 8-20 years with diabetes. Participants and their caregivers attend four structured educational sessions led by a diabetes specialist and a certified equine specialist. Topics include diabetes self-management, coping skills, problem-solving, self-advocacy, and transition readiness. Researchers will evaluate whether the program is feasible to deliver, acceptable to participants and families, and helpful in supporting engagement in diabetes care. Participants will be followed for up to six months after the program, and study outcomes include satisfaction, diabetes-related distress, self-care behaviors, clinic attendance, and diabetes technology use. In simple terms, this study is exploring whether learning about diabetes through guided activities with miniature horses can help children, adolescents, and young adults feel more confident in managing their diabetes, improve self-care skills, and become more engaged in their health care. The goal is to determine whether this innovative educational approach is practical to offer and valued by patients, families, and health care providers.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Oct 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

August 18, 2026

Last Update Submit

September 11, 2026

Conditions

Keywords

Pediatric DiabetesYoung Adults with DiabetesSelf-Management Education for DiabetesEquine -Assisted TherapyEqauine-Assisted LearningDiabetes EducationPatient Engagement

Outcome Measures

Primary Outcomes (4)

  • Participant Recruitment Rate

    Recruitment feasibility will be assessed by the proportion of eligible participants who enroll in the four-session miniature equine-assisted diabetes education program, as documented in study enrollment records.

    From study initiation through completion of enrollment (approximately 9 months)

  • Participant Retention Rate

    Retention feasibility will be assessed by the proportion of enrolled participants who remain in the study and complete scheduled study assessments, as documented in study records.

    From enrollment through completion of study participation (approximately 9 months)

  • Program Attendance Rate

    Attendance feasibility will be assessed by the proportion of scheduled miniature equine-assisted diabetes education sessions attended by participants, as documented in program attendance logs.

    From enrollment through completion of study participation (approximately 9 months)

  • Program Completion Rate

    Completion feasibility will be assessed by the proportion of enrolled participants who complete all four miniature equine-assisted diabetes education sessions.

    From enrollment through completion of study participation (approximately 9 months)

Secondary Outcomes (4)

  • Change in Diabetes Distress Assessed by the Problem Areas in Diabetes Questionnaires (PAID-C/PAID-T)

    Baseline to immediately after completion of the four-session DEEP program

  • Change in Diabetes Self-Management Behaviors Assessed by the Self-Care Inventory-Updated (SCI-U)

    Baseline to immediately after completion of the four-session DEEP program

  • Routine Diabetes Appointment Attendance Assessed by Electronic Health Record Review

    Six months before participation through six months after program completion

  • Diabetes Technology Initiation Assessed by Electronic Health Record Review

    Program completion through six months after program completion

Study Arms (1)

Diabetes & Equine Empowerment Program (DEEP)

EXPERIMENTAL

Participants in this single-arm intervention will receive the Diabetes \& Equine Empowerment Program (DEEP), a miniature equine-assisted diabetes education program. Participants and their caregivers will attend four structured sessions led by a diabetes specialist and a certified equine specialist. Sessions combine experiential learning activities with diabetes education focused on self-management, coping skills, problem-solving, self-advocacy, and transition readiness. The study will evaluate feasibility, acceptability, participant satisfaction, and exploratory psychosocial and behavioral outcomes.

Behavioral: Diabetes & Equine Empowerment Program (DEEP)

Interventions

The Diabetes \& Equine Empowerment Program (DEEP) is a behavioral and educational intervention that combines evidence-based diabetes self-management education with structured, hands-on interactions involving miniature horses. Youth with diabetes and their caregivers participate in four facilitated sessions led by a diabetes specialist and a certified equine specialist. Session activities are designed to reinforce diabetes self-management skills, coping strategies, problem-solving, communication, self-advocacy, and transition readiness through experiential learning. The intervention aims to improve participant engagement, confidence in diabetes management, and readiness for increasing independence while providing a supportive and interactive learning environment. The program is being evaluated for feasibility, acceptability, participant satisfaction, and potential effects on psychosocial and behavioral outcomes.

Also known as: DEEP, Miniature Equine-Assisted Diabetes Education
Diabetes & Equine Empowerment Program (DEEP)

Eligibility Criteria

Age8 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 8 to 20 years
  • Diagnosis of type 1 or type 2 diabetes
  • Most recent HbA1c greater than 9.0% OR no diabetes clinic follow-up for more than 6 months
  • English-speaking participant and caregiver
  • Receiving diabetes care at the participating study site
  • Willing and able to participate in the DEEP intervention
  • Able to attend all four study sessions
  • Able to provide informed consent/assent, as applicable
  • Caregiver willing to participate in study activities and assessments

You may not qualify if:

  • Non-English-speaking participant or caregiver
  • Medical, physical, cognitive, or behavioral condition that would prevent safe participation in study activities
  • Significant fear of horses that would limit participation
  • Allergy to horses that would limit participation
  • Previous participation in the DEEP intervention
  • Inability or unwillingness to complete study procedures or follow-up assessments
  • Any condition that, in the opinion of the investigators, would make participation unsafe or interfere with study completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusPatient Participation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Susana Patton, PhD, ABPP, CDCES

    Nemours Children's Health

    STUDY DIRECTOR

Central Study Contacts

Jennifer E Pfieffer, APRN, PCNS-BC, ESMHL

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment. All enrolled participants receive the DEEP intervention, a structured miniature equine-assisted diabetes education program. The study is designed as a single-arm feasibility and acceptability trial with no randomization or comparison group. Participants and caregivers complete four educational sessions that integrate experiential learning with diabetes self-management education. Outcomes are collected longitudinally to evaluate feasibility, acceptability, participant satisfaction, and exploratory psychosocial and behavioral measures.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2026

First Posted

September 16, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

September 16, 2026

Record last verified: 2026-09