PTSD Clinical Trial - What Difficulties do Children & Adolescents

Status Recruiting

Clinical Trial Summary

Post-traumatic Stress Disorder (PTSD) in children and adolescents is often associated with a myriad of significant impairments in daily functioning, including family relationships, school/work, leisure time activities, and social relationships. While a majority of attention has been placed on definition and assessment of post-traumatic stress symptoms (PTSS), less emphasis has been placed on the effect of PTSS on related functional impairment in daily life. The current assessment of PTSD-related functional impairment is conducted either with additional items inserted in PTSD measures that inquire about daily functioning or with the utilization of global functional impairment measures. The former approach is usually based on face validity only and varies content-wise. The latter approach often consists of scales that conflate symptoms with functioning, focus on impairment due to physical rather than mental health problems, and are not validated in trauma-exposed children and adolescents. Furthermore, scales usually do not include sufficient age-specific adjustments for younger children. Thus, the current assessment of PTSD-related functional impairment in children and adolescents demonstrates noteworthy shortcomings. Despite the well-recognized debilitating effect of PTSD on daily functioning, no measure has yet been developed to assess PTSD-related functional impairment tailored to trauma-exposed children and adolescents based on the input from the target population and their caregivers. The aim of this project is therefore to develop an instrument that assesses PTSD-related functional impairment in trauma-exposed children and adolescents (young children age 1-6 years (caregiver-report) as well as for older children and adolescents age 7-18 years (self- and caregiver-report)) by conducting focus groups and a Delphi survey.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

PTSD

Clinical Trial Details

NCT number	NCT05984706
Study type	Observational
Source	University Children's Hospital, Zurich
Contact	Alexandra J Vogt, M.Sc.
Phone	+41 44 266 72 39
Email	alexandra.vogt@kispi.uzh.ch
Status	Recruiting
Phase
Start date	November 20, 2023
Completion date	February 28, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03962504` - Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial	N/A
Completed	`NCT01995123` - Behavioral Activation for Smoking Cessation in PTSD	N/A
Not yet recruiting	`NCT06278922` - Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma	N/A
Completed	`NCT04597450` - Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)	Phase 1
Completed	`NCT03593772` - Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD	N/A
Completed	`NCT03429166` - Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas	N/A
Recruiting	`NCT04317820` - Deep Brain Reorienting in Post-traumatic Stress Disorder	N/A
Active, not recruiting	`NCT04588883` - Strengthening Families Living With HIV in Kenya	N/A
Completed	`NCT03504722` - Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD	N/A
Completed	`NCT04305353` - Intensive Care Unit (ICU) Diary Project	N/A
Completed	`NCT03113890` - McLean and Genomind Prospective Study	N/A
Withdrawn	`NCT05173831` - Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans	Phase 2
Not yet recruiting	`NCT04056767` - Changes in Digital Phenotype During PE Therapy
Withdrawn	`NCT03924297` - Chilipad for Sleep and Symptoms of PTSD	N/A
Completed	`NCT03343028` - Biomarker Establishment for Superior Treatment of PTSD
Completed	`NCT03158558` - Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD	N/A
Withdrawn	`NCT03216356` - Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD	Phase 2/Phase 3
Completed	`NCT02370173` - A Non-Pharmacological Method for Enhancing Sleep in PTSD	N/A
Withdrawn	`NCT01957371` - Mindful Yoga Therapy for Veterans With PTSD and Pain	N/A
Completed	`NCT01911585` - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

What Difficulties do Children and Adolescents Experience in Everyday Activities After a Traumatic Event? Focus Groups and Delphi Survey for the Development of a Questionnaire on PTSD-related Functional Impairment

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms