Parents and Young Children under Extreme Stress - PYCES

Not Applicable

Completed

• Conditions: Topic: Mental Health Research Network; Subtopic: Anxiety; Post-traumatic stress disorder; Disease: Post-traumatic stress disorder (PTSD); Mental and Behavioural Disorders

• Registration Number: ISRCTN35018680
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25872653 2021 results in https://pubmed.ncbi.nlm.nih.gov/34128219/ (added 17/06/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-18
• Study Completion: 2018-11-30
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1. Exposure to a road traffic accident, an assault, or another discrete traumatic stressor (i.e. any event that involved the threat of death, severe injury, or threat to bodily integrity, or witnessing such an event);
2. Age 3-8 years
3. Target Gender: Male & Female

Exclusion Criteria

1. Intellectual disability
2. Another primary psychiatric diagnosis
3. PTSD following another previous trauma
4. Unconscious for >15 minutes following the traumatic event
5. Not being fluent in English
6. Ongoing exposure to threat
7. History of organic brain damage
8. Risk of self-harm

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine efficacy of TF-CBT as an intervention for young children with PTSD; Timepoint(s): End of study

Secondary Outcome Measures

Name	Time	Method
<br> 1. Assess feasibility and acceptability of the intervention; timepoint(s): end of study;<br> 2. Assess mediators and moderators of outcome; timepoint(s): end of study<br> 3. Assess the course of PTSD symptoms on young children over the first 3 months post-trauma; timepoint(s): end of prospective study<br> 4. Compare cognitive variables of children with PTSD vs non-PTSD trauma-exposed children; timepoint(s): end of study<br> 5. Investigation of genetic factors in PTSD onset and in treatment response; timepoint(s): end of study<br> 6. Preliminary health economics analysis; timepoint(s): end of study<br>