Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Mental Health Care Provision for Adults With Intellectual Disability and a Mental Disorder (MEMENTA)

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Dr. Matthias Schützwohl, Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01695395
First received: September 26, 2012
Last updated: February 10, 2015
Last verified: February 2015
  Purpose

Quality of mental health services provision for adults with intellectual disability and comorbid mental disorder is considered inadequate and therefore in need of further improvement. However, empirical findings on this topic are rather scarce. The MEMENTA-study therefore aims to compare mild and moderate intellectual disabled adults with a comorbid mental disorder to mild and moderate intellectual disabled adults who do not have a comorbid mental disorder with respect to clinical parameters. The MEMENTA-study is an observational, epidemiological, cross-sectional study. A representative sample of the target population is realised by the assessment of approximately n=600 intellectual disabled adults working at specialized facilities (sheltered workshops). A cluster sampling with probability proportional to institution and size (n of overall employed persons) will be followed by a simple random sampling of persons of these clustered facilities. A number of parameters such as severity of mental health impairment, needs for care, quality of life (QoL), caregiver burden, health services utilization, and costs for care will be assessed by using a set of well-established standardised instruments. Quality of mental health care will be assessed and examined by open questions to intellectual disabled adults with a comorbid mental disorder as well as informal caregivers and staff of caring institutions.


Condition
Mental Disorder
Intellectual Disability

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Mental Health Care Provision for Adults With Mental Retardation and a Psychiatric Diagnosis

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Mental Health status [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment: 371
Study Start Date: February 2012
Study Completion Date: July 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Intellectual disabled adults without a mental disorder
Intellectual disabled adults with a mental disorder

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population are adults with mild or moderate intellectual disability.

Criteria

Inclusion Criteria:

  • mild or moderate intellectual disability
  • adults aged between 18-65 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695395

Locations
Germany
Psychiatric Health Service Research Group, Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital
Dresden, Saxony, Germany, 01219
Central Institute of Mental Health
Mannheim, Germany, 68159
Mental Health Services RU, Department of Psychiatry II, Ulm University
Ulm, Germany, 89073
Sponsors and Collaborators
Technische Universität Dresden
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Matthias Schützwohl, PD Dr. TU Dresden
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Matthias Schützwohl, PD, Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01695395     History of Changes
Other Study ID Numbers: BMBF-01GY1134
Study First Received: September 26, 2012
Last Updated: February 10, 2015
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Technische Universität Dresden:
intellectual disability
mental disorder
dual diagnosis
provision
needs assessment
quality of life

Additional relevant MeSH terms:
Intellectual Disability
Mental Disorders
Psychotic Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms

ClinicalTrials.gov processed this record on March 01, 2015