Clinical trial NCT02510664: Diabetes Strengths Study - Pilot of Provider-delivered Strengths-based Intervention
Official title: Promoting Resilience in Youth With Type 1 Diabetes: Pilot of Strengths-Based Family Intervention to Improve Diabetes Outcomes (Diabetes Strengths Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Adolescence
Adherence
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-07-29
Enrollment: 172
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether a newly developed intervention is feasible and acceptable to adolescents with type 1 diabetes and their families and diabetes care providers, and to evaluate trends in whether the intervention impacts important diabetes outcomes. The intervention involves diabetes care providers discussing and reinforcing individuals' and families' diabetes management strengths during routine, outpatient diabetes care appointments.

Detailed description: The purpose of this study is to pilot test a newly developed strengths-based clinical intervention delivered by diabetes care providers in the context of routine ambulatory diabetes care, designed to promote resilience and support diabetes management among adolescents with type 1 diabetes and their families. The emphasis of the intervention is shifting the tone of clinical encounters for diabetes care to emphasize and reinforce youths' and families' current diabetes strengths and positive diabetes management behaviors. Youth with type 1 diabetes are seen routinely in clinic every 3-4 months, and this intervention will occur at two consecutive clinic visits. The intervention consists of (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique "diabetes strengths profile" generated from the strengths and adherence assessments.

Outcome assessments are conducted at baseline (prior to the start of the intervention) and immediately following the conclusion of the intervention (approximately 6-8 months later). The primary outcome is feasibility and acceptability, measured by qualitative feedback from participants and providers, as well as quantification of recruitment and enrollment, provider adherence to intervention protocol, and time to completion. Secondary (exploratory) outcomes include diabetes regimen adherence, glycemic control, family conflict, diabetes burden, diabetes strengths, and satisfaction with the diabetes care provider relationship. Strengths and adherence assessments are also completed prior to the second clinic visit to generate the diabetes strengths profile.

Eligibility criteria: Inclusion Criteria:

1. At least one parent of each adolescent, self-identified as the primary caregiver most involved in diabetes care, will also be enrolled with each adolescent participant. When present, secondary caregivers involved in diabetes management will be invited (not required) to participate.
2. Youth type 1 diabetes diagnosis for at least 12 months, to allow ample opportunity for adjustment to diabetes management
3. Youth and parent fluency in written and spoken English because assessment measures are not available in other languages.

Exclusion Criteria:

(1) Presence of a serious mental illness or developmental disability in youth or parent that would impede participation would exclude eligibility.

Primary outcomes:
measure: Feasibility of Study Design
timeFrame: Immediately following Enrollment (Baseline)
measure: Feasibility of Study Design
timeFrame: 6-8 months after enrollment (follow-up timepoint)
measure: Feasibility of Study Design
timeFrame: 6-8 months after enrollment (follow-up timepoint)
measure: Feasibility of Study Design
timeFrame: 6-8 months after intervention begins (immediately following second study visit)
measure: Acceptability: Number of Participants That Felt the Intervention Was Well-Received
timeFrame: 6-8 months after enrollment (follow-up timepoint)
Secondary outcomes:
measure: Diabetes Strengths
timeFrame: 3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
measure: Diabetes Self-Management Profile - Parent-report
timeFrame: 3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
measure: Diabetes Self-Management Profile - Adolescent-report
timeFrame: 6-8 months after enrollment (follow-up timepoint)
measure: Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency)
timeFrame: 6-8 months after enrollment (follow-up timepoint)
measure: Glycemic Control
timeFrame: 6-8 months after enrollment (follow-up timepoint)
measure: Problem Areas in Diabetes - Teen
timeFrame: 6-8 months after enrollment (follow-up timepoint)
measure: Diabetes Burden - Problem Areas in Diabetes - Parent-report
timeFrame: 6-8 months after enrollment (follow-up timepoint)
measure: Diabetes-related Family Conflict (Parent-report)
timeFrame: 6-8 months after enrollment (follow-up timepoint)
measure: Diabetes-related Family Conflict (Adolescent Report)
timeFrame: 6-8 months after enrollment (follow-up timepoint)
measure: Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report
timeFrame: 6-8 months after enrollment (follow-up timepoint)
measure: Adolescent-provider Relationship - Adolescent-report
timeFrame: 6-8 months after enrollment (follow-up timepoint)
measure: Provider-family Relationship, Provider-report
timeFrame: 6-8 months after enrollment (follow-up timepoint)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Marisa E Hilliard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hilliard ME, Eshtehardi SS, Minard CG, Wheat S, Gunn S, Sanders C, Klenk R, Anderson BJ. Featured Article: Strengths-Based, Clinic-Integrated Nonrandomized Pilot Intervention to Promote Type 1 Diabetes Adherence and Well-Being. J Pediatr Psychol. 2019 Jan 1;44(1):5-15. doi: 10.1093/jpepsy/jsy051.