Study of Impact of Art Therapy Sessions Given to Family C... | NCT02797730

Studies
Study of Impact of Art Therapy Sessions Given to Family Caregivers of Children With Type 1 Diabetes

NCT02797730

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Apr 14, 2020Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Quality of Life

Interventions

art-therapy sessions

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

May 20, 2016

First Submission Date that Met QC Criteria

Jun 8, 2016

First Posted Date

Jun 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2020

Last Update Posted Date

Apr 14, 2020Actual

Description Module

Brief Summary

Diagnostic of diabetes in childhood brought modification of family way of life, particularly in child and caregivers lifes.

The education patient programs are in France centered on curative competencies of care.

It is possible that art-therapy improve psycho-social competencies The aim of the study is to evaluate art-therapy sessions on quality of life of caregivers

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
art-therapy sessions	Experimental	Caregivers will receive 6 art-therapy sessions	Behavioral: art-therapy sessions
no art-therapy sessions	No Intervention	Caregivers will not receive 6 art-therapy sessions during the evaluation period

Interventions

Name	Type	Description	Arm Group Labels	Other Names
art-therapy sessions	Behavioral		art-therapy sessions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PedsQL Family Impact score to assess Family Quality of Life		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Anxiety score of caregivers		6 weeks
self esteem score of caregivers		6 weeks
quality of life score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

one of the family caregivers of child with diabetes enrolled in patient education programs of 3 hospitals (Hospital of Poitiers, Hospital of Niort and Hospital of La Rochelle)
who accept the study
≥ 18 years
free, with protection of vulnerable adult
caregivers of child with who have insurance
with free, enlightened, signed consent

Exclusion Criteria:

other research participation
< 18 years
host family
with protection of vulnerable adult
caregivers of child with who have not insurance

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
La rochelle		La Rochelle		17 000	France
NIORT