NCT03698708

Brief Summary

The purpose of this study is to evaluate a new intervention (CARES: Cognitive Adaptations to Reduce Emotional Stress Associated with Type 1 Diabetes) designed to reduce caregiver depressive symptoms in families of children with T1D. This is a pilot in which all enrolled parents/caregivers will be placed in the intervention group to assess initial pre- to post-treatment impact of the intervention on parent/caregiver depression, distress, and diabetes-related outcomes (e.g., glycemic control).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 20, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 11, 2022

Completed
Last Updated

February 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

October 3, 2018

Results QC Date

December 16, 2021

Last Update Submit

January 18, 2022

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Problem Areas in Diabetes Survey - Parent Revised (PAID-PR)

    Problem Areas in Diabetes Survey - Parent Revised (PAID-PR); Parents' perceptions of diabetes-related distress, which can encompass fear, sadness, grief, anger, burn-out, and guilt. Higher scores reflect greater perceived distress (range: 0-72)

    absolute value Post-treatment (week 24)

  • Center for Epidemiologic Studies - Depression Scale Revised (CESD-R)

    Center for Epidemiologic Studies - Depression Scale Revised (CESD-R); measure of parental depressive symptoms. Used as a secondary marker of improvement. Higher scores reflect greater occurrence of depressive symptoms (range: 0-60)

    absolute value at Post-treatment (week 24)

Secondary Outcomes (3)

  • Hypoglycemia Fear Survey (HFS-P)

    absolute value Post-treatment (week 24)

  • Diabetes Family Conflict Scale (DFCS)

    absolute value Post-treatment (week 24)

  • Hemoglobin A1c (HbA1c)

    absolute value at Post-treatment (week 24)

Other Outcomes (1)

  • Treatment Satisfaction Survey

    absolute value at post-treatment (week 12)

Study Arms (2)

CARES Intervention- 12 sessions

EXPERIMENTAL

Participants in the intervention will participate in 12 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.

Behavioral: CARES Intervention

CARES Intervention- 8 sessions

EXPERIMENTAL

Participants in the intervention will participate in 8 weekly group-based telemedicine intervention sessions (up to 60 minutes each) with other parents/caregivers of children with T1D. Intervention sessions focus on cognitive-behavioral therapy to treat depression, including identifying cognitive distortions, cognitive restructuring, behavioral activation, coping strategies, and learning diabetes management skills.

Behavioral: CARES Intervention

Interventions

CARES InterventionBEHAVIORAL

A group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.

CARES Intervention- 12 sessionsCARES Intervention- 8 sessions

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parent/primary caregiver of a child diagnosed with T1D between 5-12 years old
  • Parent/caregiver elevated depression symptoms on the CESD-R (score ≥ 16 at time of screening)
  • Child with T1D receiving intensive insulin regimen by multiple dose injections (MDI) or continuous subcutaneous insulin infusion (pump)

You may not qualify if:

  • Child with T1D currently in foster care or not living with legal guardian
  • Child with evidence of type 2 diabetes or monogenic diabetes
  • Child with a co-morbid chronic illness (e.g., renal disease) that requires ongoing care beyond T1D
  • Children who are chronically using medications that may impact glycemic control (i.e., systemic steroids)
  • Parents/caregivers who do not speak English (currently there is no way to recruit non-English speaking families because the study questionnaires are only available in English)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (2)

  • Case H, Williams DD, Majidi S, Ferro D, Clements MA, Patton SR. Longitudinal associations between family conflict, parent engagement, and metabolic control in children with recent-onset type 1 diabetes. BMJ Open Diabetes Res Care. 2021 Oct;9(1):e002461. doi: 10.1136/bmjdrc-2021-002461.

    PMID: 34645616DERIVED

  • McConville A, Noser AE, Nelson EL, Clements MA, Majidi S, Patton SR. Depression as a predictor of hypoglycemia worry in parents of youth with recent-onset type 1 diabetes. Pediatr Diabetes. 2020 Aug;21(5):909-916. doi: 10.1111/pedi.13039. Epub 2020 May 29.

    PMID: 32410305DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

Original proposal called to pilot the CARES in n=12; we recruited additional participants to simultaneously trial the 8-session CARES version. These results are preliminary and require confirmation in a fully powered comparative effectiveness trial.

Results Point of Contact

Title
Dr. Susana Patton
Organization
Nemours Children's Health
susana.patton@nemours.org
904-697-2000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 9, 2018

Study Start

January 20, 2019

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

February 11, 2022

Results First Posted

February 11, 2022

Record last verified: 2022-01

Locations

US(1)