Trial Outcomes & Findings for Diabetes Strengths Study - Pilot of Provider-delivered Strengths-based Intervention (NCT NCT02510664)

NCT ID: NCT02510664

Last Updated: 2020-02-24

Results Overview

Measured by percent of recruited families that enrolled in study

Recruitment status

COMPLETED

Study phase

Target enrollment

172 participants

Primary outcome timeframe

Immediately following Enrollment (Baseline)

Results posted on

2020-02-24

Participant Flow

Recruited from diabetes clinics at Texas Children's Hospital

Of 172 individuals (84 parents, 84 adolescents, 4 providers) consented, n=40 (20 parent-adolescent dyads) did not receive the intervention: 18 (9 dyads) transferred care to a provider not trained in intervention, 20 (10 dyads) because their provider retired \& insufficient time to reschedule in study period, 2 (1 dyad) due to time constraints

Participant milestones

Participant milestones
Measure	Adolescent There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Adolescent group completed different sets of questionnaires than the Parent and Provider groups. Diabetes Strengths Study: 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.	Parent There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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 assessment.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Overall Study STARTED	84	84	4
Overall Study COMPLETED	64	64	4
Overall Study NOT COMPLETED	20	20	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Adolescent There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Adolescent group completed different sets of questionnaires than the Parent and Provider groups. Diabetes Strengths Study: 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.	Parent There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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 assessment.
Overall Study Transferred Care	9	9
Overall Study Provider Retired/No Time to Reschedule	10	10
Overall Study Time Constraints	1	1

Baseline Characteristics

n represents number with complete data to calculate a score. Ages are not reported for Parents and Providers because the data were not collected.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Immediately following Enrollment (Baseline)

Population: Over 12 months (10/2014-9/2015), staff screened 212 adolescents for eligibility via electronic medical record, of whom 8 could not be contacted, 11 opted out of learning about research before the study could be introduced, \& 88 were ineligible. Of the remaining 105 adolescents, 21 declined to participate, resulting in a consent rate of 80% (n=84).

Measured by percent of recruited families that enrolled in study

Outcome measures

Outcome measures
Measure	Parent n=105 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent n=105 Participants There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Feasibility of Study Design	84 Participants	84 Participants	—

PRIMARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: 84 ppts enrolled. 64 (76% of consented, 61% of eligible invited to participate) completed baseline surveys \& were eligible to participate in the intervention. 63 (75% of consented, 98% of ppts with baseline data) received at least one intervention session. 53 (63% of consented, 83% of ppts with baseline data) completed 2 intervention sessions.

Measured by percent of enrolled participants who receive full dose

Outcome measures

Outcome measures
Measure	Parent n=84 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent n=84 Participants There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Feasibility of Study Design	53 Participants	53 Participants	—

PRIMARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: Includes participants who completed post-intervention data

Measured by time to complete intervention in months since enrollment in study.

Outcome measures

Outcome measures
Measure	Parent n=63 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent n=63 Participants There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Feasibility of Study Design	8.3 months since enrollment Standard Deviation 3.6	8.3 months since enrollment Standard Deviation 3.6	—

PRIMARY outcome

Timeframe: 6-8 months after intervention begins (immediately following second study visit)

Population: Out of 84 enrolled and 64 who provided baseline data, 60 (71% of enrolled, 94% of ppts with baseline data) provided post-intervention questionnaire battery (some individual measures may not have been complete to calculate a score)

Measured by percent of participants who provided complete data from all questionnaires.

Outcome measures

Outcome measures
Measure	Parent n=84 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent n=84 Participants There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider n=4 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Feasibility of Study Design	60 Participants	60 Participants	4 Participants

PRIMARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: n = number with complete data at this follow-up timepoint to calculate a score.

The number of participants that felt the intervention was well-received was collected for Adolescents, Parents, and Providers. To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team. We coded these data qualitatively and classified them as Positive, Negative, or Neutral.

Outcome measures

Outcome measures
Measure	Parent n=53 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent n=52 Participants There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider n=4 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Acceptability: Number of Participants That Felt the Intervention Was Well-Received Positive	46 Participants	44 Participants	4 Participants
Acceptability: Number of Participants That Felt the Intervention Was Well-Received Negative	0 Participants	0 Participants	0 Participants
Acceptability: Number of Participants That Felt the Intervention Was Well-Received Neutral	7 Participants	8 Participants	0 Participants

SECONDARY outcome

Timeframe: 3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)

Population: n = number with complete data at baseline to calculate a score

Adolescent will self-report on the frequency of 12 resilience-promoting behaviors via the Diabetes Strengths and Resilience, a self-report assessment of positive behaviors related to diabetes resilience for youth with type 1 diabetes, such as perceived competence to manage the demanding diabetes regimen, to adapt to the unpredictability of diabetes, and to seek help and support with diabetes challenges. The scale ranges from 0-48, with a higher score representing a better outcome.

Outcome measures

Outcome measures
Measure	Parent n=64 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Diabetes Strengths 3-4 months after enrollment (mid-intervention)	38.1 units on a scale Standard Deviation 5.6	—	—
Diabetes Strengths 6-8 months after enrollment (follow-up timepoint)	39.7 units on a scale Standard Deviation 5.8	—	—

SECONDARY outcome

Timeframe: 3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)

Population: n = number with complete data at baseline timepoint to calculate a score

Parents will rate adolescents' adherence to the diabetes regimen using the 24-item Diabetes Self-Management Profile Self-Report. The version appropriate to their child's current diabetes regimen (conventional insulin regimen, 24 items; flexible insulin regimen, 24 items) was administered. The scale ranges from 0-86, with a higher score representing a better outcome.

Outcome measures

Outcome measures
Measure	Parent n=63 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Diabetes Self-Management Profile - Parent-report 3-4 months after enrollment (mid-intervention)	55.2 units on a scale Standard Deviation 9.5	—	—
Diabetes Self-Management Profile - Parent-report 6-8 months after enrollment (follow-up timepoint)	56.9 units on a scale Standard Deviation 10.0	—	—

SECONDARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: n = number with complete data at this follow-up timepoint to calculate a score

Adolescents will complete the youth-report version of the Diabetes Self-Management Profile Self-Report, a self-reported measure of adherence to diabetes regimen, at baseline and follow-up to assess their perceptions of adherence. The version appropriate to the adolescents' current diabetes regimen (conventional insulin regimen, 24 items; or intensive insulin regimen, 24 items) will be administered. The scale ranges from 0-86, with a higher score representing a better outcome.

Outcome measures

Outcome measures
Measure	Parent n=59 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Diabetes Self-Management Profile - Adolescent-report	56.9 units on a scale Standard Deviation 10.1	—	—

SECONDARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: n = number with complete meter data at this follow-up timepoint to calculate a score

Objective measurement of adherence will occur through blood glucose monitoring frequency (a well-accepted surrogate of overall adherence), obtained via blood glucose meter downloads. The average daily frequency will be calculated over the 14 days prior to the assessment at the Baseline and second study visits.

Outcome measures

Outcome measures
Measure	Parent n=53 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency)	3.64 checks per day Standard Deviation 1.36	—	—

SECONDARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: n = number with HbA1c value available at this follow-up timepoint

Diabetes is typically diagnosed with an HbA1c of 6.5% or higher. At the time of this study, the American Diabetes Association generally recommended an HbA1c target of \<7.5% for individuals younger than 18 years (the specific target varies depending on the individual). The DCA 2000 HbA1c Analyzer (Siemens-Bayer) was used for point of care HbA1c analysis, it has an analytical measurement range for HbA1c of 2.5% to 14.0%. HbA1c values are collected via fingerstick and blood assay at routine diabetes care visits and values will be extracted from the medical record at each clinic visit during the study period.

Outcome measures

Outcome measures
Measure	Parent n=59 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Glycemic Control	8.54 percentage Standard Deviation 1.59	—	—

SECONDARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: n = number with complete data at this follow-up timepoint to calculate a score

Burden will be assessed via the Problem Areas in Diabetes - Teen. The scale has 26 items and demonstrates good psychometric properties. The scale ranges from 26-156, with higher scores representing worse outcomes.

Outcome measures

Outcome measures
Measure	Parent n=61 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Problem Areas in Diabetes - Teen	61.6 units on a scale Standard Deviation 23.6	—	—

SECONDARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: n = number with complete data at this timepoint to calculate a score

Burden will be assessed via the Problem Areas in Diabetes measures for parents. The scale has 26 items and demonstrates good psychometric properties. The scale ranges from 26-156, with a higher score representing a worse outcome.

Outcome measures

Outcome measures
Measure	Parent n=59 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Diabetes Burden - Problem Areas in Diabetes - Parent-report	64.6 units on a scale Standard Deviation 20.3	—	—

SECONDARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: n = number with complete data at this follow-up timepoint to calculate a score

Parents will complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity. The scale ranges from 19-57, with higher scores representing a worse outcome.

Outcome measures

Outcome measures
Measure	Parent n=58 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Diabetes-related Family Conflict (Parent-report)	24.9 units on a scale Standard Deviation 4.6	—	—

SECONDARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: n = number with complete data at this follow-up timepoint to calculate a score

Adolescents will also complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity. The scale ranges from 19-57, with higher scores representing a worse outcome.

Outcome measures

Outcome measures
Measure	Parent n=60 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Diabetes-related Family Conflict (Adolescent Report)	24.3 units on a scale Standard Deviation 4.8	—	—

SECONDARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: n = number with complete data at this follow-up timepoint to calculate a score

To assess healthcare satisfaction, parents will complete three subscales of the PedsQL Inventory Healthcare Satisfaction Generic Module, assessing their satisfaction with communication, inclusion of family, and how well the patient's emotional needs are addressed during the clinical encounter (13 items). The scale ranges from 0-100, with a higher score representing a better outcome.

Outcome measures

Outcome measures
Measure	Parent n=59 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report	96.1 units on a scale Standard Deviation 10.3	—	—

SECONDARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: n = number with data at this follow-up timepoint.

Adolescents will rate their overall satisfaction with the patient-provider relationship on a 1-10 scale single item developed for this study, as there is no validated youth-report measure of satisfaction with care. The scale ranges from 1-10, with higher scores representing a better outcome.

Outcome measures

Outcome measures
Measure	Parent n=56 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Adolescent-provider Relationship - Adolescent-report	8.5 units on a scale Standard Deviation 1.8	—	—

SECONDARY outcome

Timeframe: 6-8 months after enrollment (follow-up timepoint)

Population: n represents number with complete data to calculate a score. 4 healthcare providers completed this scale for 48 families (adolescent-parent dyads).

Providers will rate their overall satisfaction with the provider-family relationship on a scale developed for this study. The Provider-Family Relationship scale measures the provider's perspective on the quality of their relationship with the teen and family. 4 healthcare providers completed this scale for 48 families. The scale range of the minimum to maximum possible score is 1-10. A higher score represents a better outcome.

Outcome measures

Outcome measures
Measure	Parent n=48 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Parent There is no control/comparator group for this pilot study - all adolescents and their parents receive the intervention that is delivered by a participating provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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.	Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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.
Provider-family Relationship, Provider-report	9.1 units on a scale Standard Deviation 1.0	—	—

Adverse Events

Adolescent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Provider

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marisa Hilliard PhD, Principal Investigator

Baylor College of Medicine

Phone: 832-824-7209

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Adolescent n=64 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Adolescent group completed different sets of questionnaires than the Parent and Provider groups. Diabetes Strengths Study: 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.	Parent n=64 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups. Diabetes Strengths Study: 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	Provider n=4 Participants There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints. Diabetes Strengths Study: 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	Total n=132 Participants Total of all reporting groups
Age, Continuous	15.0 years STANDARD_DEVIATION 1.8 • n=64 Participants • n represents number with complete data to calculate a score. Ages are not reported for Parents and Providers because the data were not collected.	—	—	15.0 years STANDARD_DEVIATION 1.8 • n=64 Participants • n represents number with complete data to calculate a score. Ages are not reported for Parents and Providers because the data were not collected.
Sex: Female, Male Female	36 Participants n=64 Participants • n represents number with complete data to calculate a score. Sex is not reported for Providers because the data were not collected.	53 Participants n=64 Participants • n represents number with complete data to calculate a score. Sex is not reported for Providers because the data were not collected.	—	89 Participants n=128 Participants • n represents number with complete data to calculate a score. Sex is not reported for Providers because the data were not collected.
Sex: Female, Male Male	28 Participants n=64 Participants • n represents number with complete data to calculate a score. Sex is not reported for Providers because the data were not collected.	11 Participants n=64 Participants • n represents number with complete data to calculate a score. Sex is not reported for Providers because the data were not collected.	—	39 Participants n=128 Participants • n represents number with complete data to calculate a score. Sex is not reported for Providers because the data were not collected.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.	—	—	0 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.
Race (NIH/OMB) Asian	4 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.	—	—	4 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.	—	—	0 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.
Race (NIH/OMB) Black or African American	8 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.	—	—	8 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.
Race (NIH/OMB) White	44 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.	—	—	44 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.
Race (NIH/OMB) More than one race	8 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.	—	—	8 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.	—	—	0 Participants n=64 Participants • n represents number with complete data to calculate a score. Race is not reported for Parents and Providers because the data were not collected.
Region of Enrollment United States	64 participants n=64 Participants • n represents number with complete data to calculate a score.	64 participants n=64 Participants • n represents number with complete data to calculate a score.	4 participants n=4 Participants • n represents number with complete data to calculate a score.	132 participants n=132 Participants • n represents number with complete data to calculate a score.
Diabetes Strengths and Resilience Measure - Adolescent	37.0 units on a scale STANDARD_DEVIATION 6.6 • n=64 Participants • n represents number with complete data to calculate a score.	—	—	37.0 units on a scale STANDARD_DEVIATION 6.6 • n=64 Participants • n represents number with complete data to calculate a score.
Diabetes Self-Management Profile - Adolescent Self-Report	52.5 units on a scale STANDARD_DEVIATION 10.3 • n=62 Participants • n represents number with complete data to calculate a score.	—	—	52.5 units on a scale STANDARD_DEVIATION 10.3 • n=62 Participants • n represents number with complete data to calculate a score.
Diabetes Self-Management Profile - Parent-report	—	54.4 units on a scale STANDARD_DEVIATION 9.2 • n=63 Participants • n represents number with complete data to calculate a score.	—	54.4 units on a scale STANDARD_DEVIATION 9.2 • n=63 Participants • n represents number with complete data to calculate a score.
Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency)	3.6 checks per day STANDARD_DEVIATION 1.4 • n=58 Participants • n represents number with complete data to calculate a score.	—	—	3.6 checks per day STANDARD_DEVIATION 1.4 • n=58 Participants • n represents number with complete data to calculate a score.
Glycemic Control (HbA1c)	8.56 percentage STANDARD_DEVIATION 1.60 • n=62 Participants • n represents number with complete data to calculate a score.	—	—	8.6 percentage STANDARD_DEVIATION 1.6 • n=62 Participants • n represents number with complete data to calculate a score.
Problem Areas in Diabetes - Adolescent Self-report	68.6 units on a scale STANDARD_DEVIATION 28.0 • n=64 Participants • n represents number with complete data to calculate a score.	—	—	68.6 units on a scale STANDARD_DEVIATION 28.0 • n=64 Participants • n represents number with complete data to calculate a score.
Problem Areas in Diabetes - Parent-report	—	71.3 units on a scale STANDARD_DEVIATION 25.2 • n=64 Participants • n represents number with complete data to calculate a score.	—	71.3 units on a scale STANDARD_DEVIATION 25.2 • n=64 Participants • n represents number with complete data to calculate a score.
Diabetes Family Conflict Scale - Revised, Adolescent-report	25.5 units on a scale STANDARD_DEVIATION 5.7 • n=62 Participants • n represents number with complete data to calculate a score.	—	—	25.5 units on a scale STANDARD_DEVIATION 5.7 • n=62 Participants • n represents number with complete data to calculate a score.
Diabetes Family Conflict Scale - Revised, Parent-report	—	24.7 units on a scale STANDARD_DEVIATION 4.8 • n=64 Participants • n represents number with complete data to calculate a score.	—	24.7 units on a scale STANDARD_DEVIATION 4.8 • n=64 Participants • n represents number with complete data to calculate a score.
Adolescent-provider relationship, adolescent-report	7.9 units on a scale STANDARD_DEVIATION 1.6 • n=62 Participants • n represents number with complete data to calculate a score	—	—	7.9 units on a scale STANDARD_DEVIATION 1.6 • n=62 Participants • n represents number with complete data to calculate a score
Provider-family relationship, provider-report	—	—	8.7 units on a scale STANDARD_DEVIATION 1.0 • n=4 Participants • n represents number with complete data to calculate a score. 4 healthcare providers completed this scale for 60 families.	8.7 units on a scale STANDARD_DEVIATION 1.0 • n=4 Participants • n represents number with complete data to calculate a score. 4 healthcare providers completed this scale for 60 families.
PedsQL-Healthcare Satisfaction, parent-report	—	96.4 units on a scale STANDARD_DEVIATION 6.5 • n=63 Participants • n represents number with complete data to calculate a score.	—	96.4 units on a scale STANDARD_DEVIATION 6.5 • n=63 Participants • n represents number with complete data to calculate a score.