NCT03330145

Brief Summary

The purpose of this study is to identify risk factors of Complicated Grief (CG) among children and adolescents who lost a parent to cancer or from an other cause.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

November 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

4.4 years

First QC Date

May 27, 2016

Last Update Submit

July 22, 2021

Conditions

Grief

Keywords

Complicated GriefRisk FactorsCancerChildren

Outcome Measures

Primary Outcomes (1)

  • Inventory of Complicated Grief

    Complicated Grief symptoms at 6 months post-loss among children aged from 6 to 17 years Measured by the Inventory of Complicated Grief

    6 months post-loss

Secondary Outcomes (8)

  • Inventory of Complicated Grief for Evaluation of paths of grief symptoms developement

    At 3 and 12 months post-loss

  • Influence of grief symptoms of the parent staying in life

    At 3 months and 12 months post-loss

  • Evaluation of the impact of the cause of parents death (cancer or other cause) on complicated grief symptoms development.

    At 6 and 12 months post-loss

  • Evaluation of the impact of the cause of parents death (cancer or other cause) on post-traumatic stress developement.

    At 6 and 12 months post-loss

  • Evaluation of the impact of the cause of parents death (cancer or other cause) on depression developement.

    At 6 and 12 months post-loss

  • +3 more secondary outcomes

Study Arms (2)

children who lost a parent to cancer

EXPERIMENTAL

Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss

Behavioral: Scales, questionnaires and inventory

children who lost a parent not to cancer

ACTIVE COMPARATOR

Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss

Behavioral: Scales, questionnaires and inventory

Interventions

Scales, questionnaires and inventoryBEHAVIORAL

Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss

Also known as: Inventory
children who lost a parent not to cancerchildren who lost a parent to cancer

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children :
  • Having lost a parent within the last 3 months
  • Signed consent form from the parent
  • To have health care coverage by the French social security
  • Parents :
  • Signed consent form
  • Having lost mother or father of the child within the last 3 months

You may not qualify if:

  • Children:
  • Both parents are dead
  • Medical disease
  • Ongoing legal procedure regarding the death
  • Parents :
  • Decline to take part to the study
  • Mental retardation or schizophrenia
  • Ongoing legal procedure regarding the death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatrie de l'enfant et de l'adolescent

Toulouse, 31000, France

Location

Related Publications (1)

  • Revet A, Suc A, Auriol F, Djelantik AAAMJ, Raynaud JP, Bui E. Peritraumatic distress predicts prolonged grief disorder symptom severity after the death of a parent in children and adolescents. Eur J Psychotraumatol. 2021 Jun 28;12(1):1936916. doi: 10.1080/20008198.2021.1936916. eCollection 2021.

    PMID: 34249245RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Weights and MeasuresSurveys and QuestionnairesEquipment and Supplies

Intervention Hierarchy (Ancestors)

Investigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jean-Philippe RAYNAUD, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 27, 2016

First Posted

November 6, 2017

Study Start

November 1, 2015

Primary Completion

April 1, 2020

Study Completion

May 1, 2020

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)