Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03558815
Other study ID # 040_5121
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date May 31, 2019

Study information

Verified date July 2019
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Mental health service provision of adults with intellectual disabilities (ID) is often criticized. There is a lack of empirically studies targeting the psychotropic and psychotherapeutic treatment in this population. The PROMPT-ID study therefore aims to assess the prevalence of psychotropic medication and psychotherapeutic treatment in adults with mild to profound ID and the quality of psychotropic medication. It further aims to identify predictors of psychotropic medication, of barriers into psychotherapeutic treatment and of good clinical psychotropic medication prescription practice. It is a cross-sectional, epidemiological study carried out in Saxony, Germany. Approval of the responsible ethics committee was obtained. The inclusion criteria are mild to profound forms of ID and an age of 18 years or older. A representative sample is realized by a two-stage sampling procedure. Sheltered working and accommodation service providers are stratified by type of service provider and workshop size/type of accommodation. The stratified cluster sampling is realized by a random selection of service providing institutions followed by a random selection of adults with ID. An estimated total number of n = 200 study participants via sheltered workshops and n = 400 via residential accommodations need to be contacted to obtain data of approximately n = 131 study participants recruited through sheltered workshops and n = 232 participants through sheltered living institutions. Based on a psychotropic medication prevalence of 30%, in- depth interviews about psychotropic prescription practice of an estimated number of n = 109 adults with ID are carried out. Data collection is realized in interviews with key carers in the living environment and, if applicable, with the prescribing physician. If the adults with ID are currently medicated with psychotropics, basic information e.g. about kind, agent, dosage and treatment duration are obtained and a newly developed interview targeting the quality of the psychotropic medication treatment is conducted with the carers. In addition to the prevalence and quality of psychotropic and psychotherapeutic health care utilisation, other parameters like psychiatric symptomatology, problem behavior, sociodemografic and institutional factors and parameters of the provision area are assessed using well- established instruments. Findings will fill the lack of representative data that is urgently needed in this often criticized health service area.


Recruitment information / eligibility

Status Completed
Enrollment 197
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Mild to profound levels of ID

- Age of 18 years or older

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of psychiatry and Psychotherapy Dresden

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of psychotropic medication (Interview for Assessing the Quality of Psychopharmacological Treatment of Adults with Intellectual Disabilities (IQP-ID; Schützwohl et al., 2017) If the adults with ID had a psychotropic medication prescription of at least one of the following six substance classes in the past three months: neuroleptics, antidepressants, benzodiazepines, lithium, anxiolytics/sedatives and/or antiepileptics, the Interview for Assessing the Quality of Psychopharmacological Treatment of Adults with Intellectual Disabilities (IQP-ID; Schützwohl et al., 2017) is conducted. This interview assesses the prescription practice of psychotropic medication in adults with ID. It is based on current guidelines of psychotropic medication prescription in adults with ID.The interview comprises 13 quality indicators that are assigned to one of 7 domains. 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT05935722 - Evaluation of a Home-based Parenting Support Program: Parenting Young Children N/A
Completed NCT04020302 - Self-Monitoring Shopping Intervention N/A
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Completed NCT03722212 - Early Diagnosis of the GLUT1 Deficiency Syndrome With a Blood Based Test N/A
Not yet recruiting NCT03644797 - Second Molecular Event Identification by Exome Sequencing for Intellectually Disabled Patients Carrying 16p13.11 CNVs
Not yet recruiting NCT02881333 - Various Type of Genetic Events in Patients With Intellectual Disability N/A
Completed NCT03139760 - POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability N/A
Completed NCT02746614 - Psychomotor Therapy Effects in Adaptive Behavior and Motor Proficiency in Intellectual Disability N/A
Completed NCT06097819 - Therapy-Based Games' Effects on Motor and Cognitive Skills in Intellectual Disabilities N/A
Recruiting NCT05767203 - Genetic Markers and Biomarkers in Patients With Intellectual Disabilities of Genetic Origin N/A
Terminated NCT05445596 - Improving Treatment for Children With Intellectual and Developmental Disabilities and Problem Behavior in Schools N/A
Recruiting NCT05131425 - Facing Your Fears: Adolescents With ASD and Intellectual Disability N/A
Completed NCT04436692 - Dietary Intervention and Adults With Intellectual Disabilities N/A
Completed NCT04917666 - Process and Outcomes of Horticultural Therapy for People With Disabilities N/A
Completed NCT04518358 - Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational Skills N/A
Completed NCT04554355 - Effects of a PA Intervention for Fatness and Fitness in Adolescents With Intellectual Disability N/A
Completed NCT04277130 - Effectiveness of Active Video Games in Children With Intellectual Disabilities N/A
Enrolling by invitation NCT02914951 - Cognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability N/A
Completed NCT02591446 - Transcranial Magnetic Stimulation Studies in Autism Spectrum Disorders N/A
Completed NCT03989388 - Occupational Self-Analysis Programme N/A