Systematic Psychological and Medical Care for Children With SCD

NCT ID: NCT02022891

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-05-31

Brief Summary

Sickle cell disease (SCD), a genetically transmitted blood disease, necessitates life-long care. In children, the disease may cause intense pain and other severe complications. Studies show that sources of stress, as well as complex psychological and intercultural issues associated with SCD, often aggravate symptoms. At Louis Mourier hospital, the treatment model used is systematic psychological and medical care. Our hypothesis is that this care is beneficial for both the children and their families as seen in improved quality of life and positive impact on medical symptoms.

Detailed Description

In this observational multicentric pilot study, our goal is to assess the effectiveness of a systematic medical-psychological approach in place for the past 6 years at the Louis Mourier Hospital, as compared to the usual practice in 2 other pediatric hospitals for SCD which focus essentially on the medical issues associated with SCD. Two psychologists will interview 80 children and their primary care-takers at Louis Mourier hospital, and 80 children and their care-takers of the other two centers, using a standard comprehensive care for SCD. For the parents, we propose to use a semi-structured interview including a prepared interview guide, the Loneliness Questionnaire, and the parents' version of KIDSCREEN (10 items). For the children, according to their age, The Rey-Osterrieth Complex Figure Test (ROCF), the Draw a Person in the Rain Test (DPR), the KIDSCREEN questionnaire, and semi-directed interview will be used. Relevant information from the patients' medical record directly related to the symptomatic expression of the SCD will be noted on a data collection form. This phase is scheduled to last 12 months. A statistical and qualitative analysis of the results will be carried out at the end of the study.

Conditions

Anemia, Sickle Cell

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

systematic psychological care

Systematic psychological treatment plan added to medical care for children with SCD. Bio-psychosocial paradigm applied at pediatric consultations.

No interventions assigned to this group

Control

medical care only at routine pediatric consultations for SCD. Psychological support provided only when the pediatrician consider it appropriate.

systematic psychological care

Intervention Type: BEHAVIORAL

Prevention treatment plan that provides systematic medical and psychological care at routine pediatric consultations for SCD. Bio-psychosocial paradigm applied at pediatric consultations.

Interventions

systematic psychological care

Prevention treatment plan that provides systematic medical and psychological care at routine pediatric consultations for SCD. Bio-psychosocial paradigm applied at pediatric consultations.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• children with sickle cell disease
• treated in one of the three investigational centers
• All major forms of the disease will be studied regardless of the country of origin.

Exclusion Criteria

• Refusal of the parents or the child to participate.
• Child or parent living in France for less than 6 months

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Hélène ODIEVRE, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Louis Mourier, Colombes, France 92

Locations

Hôpital Louis Mourier

Colombes, , France

Countries

France

Other Identifiers

SC_MOE_2012-6

Identifier Type: -

Identifier Source: org_study_id