Skip to content

Treating children with post-traumatic stress disorder (PTSD) following an accidental injury: a multicentre randomised controlled trial

Comparison of cognitive-behavioural treatments for children with post-traumatic stress disorder (PTSD) following an accidental injury: a multicentre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79049138
Enrollment
140
Registered
2010-08-12
Start date
2009-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic stress disorder/post-traumatic stress symptoms Mental and Behavioural Disorders Post-traumatic stress disorder

Interventions

Participants are randomly allocated to one of three conditions: 1. Family-focused CBT condition: Participants allocated to this condition receive a 10-week intervention, comprised of 4 weekly parent s

Sponsors

Centre of National Research on Disability and Rehabilitation Medicine (CONROD) (Australia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 7 and 16 years, either sex 2. Admission to hospital for accidental trauma/injury 3. Admission to hospital for minimum 6 hours (overnight stay) 4. Endorsement of greater than or equal to 5 items on the Child Trauma Screening Questionnaire within two weeks of admission ('at-risk' of developing PTSD) 5. Elevated clinical symptoms as identified on the structured diagnostic interview, the Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA), 4 - 6 weeks following hospital admission

Exclusion criteria

Exclusion criteria: 1. Parent's English insufficient for questionnaire completion 2. Developmental delay or mental retardation in the child 3. Moderate-severe head injury or post-traumatic amnesia following the accident 4. Severe depression or suicide risk in the child 5. Alcohol, substance abuse or psychosis in the caregiver 6. Under the care of the Department of Child Safety 7. Injury due to physical or sexual abuse

Design outcomes

Primary

MeasureTime frame
Assessment of post-traumatic stress symptoms. Diagnostic status (of PTSD), symptom severity and associated disability/impairment will be assessed using the Clinician Administered PTSD Scale for Children (CAPS-CA). The CAPS will be administered pre-randomisation, post-intervention and at 6 and 12 month follow-up.

Secondary

MeasureTime frame
Measures administered during hospital admission: 1. Children's injury severity, assessed using the Injury Severity Score and Abbreviated Injury Scale Measures administered at screening stage (1 - 2 weeks post-hospital admission): 2. Children's trauma symptoms/risk indicators, assessed using the Child Trauma Screening Questionnaire (CTSQ); also measured at pre-randomisation, 4-weeks post-randomisation, post-intervention, 6 and 12 months follow-up Measures administered at pre-randomisation, 4-weeks post-randomisation, post-intervention, 6 and 12 months follow-up: 3. Children's PTSD symptoms, measured through the self-report Child PTSD Symptom Scale (CPSS) 4. Children's anxiety symptoms, measured using the Spence Child Anxiety Scale (SCAS) 5. Children's depression symptoms, measured through the Child Depression Inventory (CDI) 6. Children's quality of life, measured through the Pediatric Quality of Life Inventory, Child and Parent Versions (PedsQL) 7. Children's internalising and externalising symptoms, measured by the Child Behavior Checklist (CBCL) 8. Intensity of children's pain, measured through the Faces Pain Scale - Revised (FPS-R) 9. Parent's PTSD symptoms, assessed through the self-report Post-traumatic Stress Diagnostic Scale 10. Parental psychopathology, assessed using the Depression Anxiety and Stress Scale (DASS) 11. Parental state and trait anxiety, measured by the State Trait Anxiety Inventory (STAI) In addition, treatment satisfaction will be measured through a Program Satisfaction Questionnaire, completed by parents and children following the intervention. Global distress and improvement will be assessed at 4-weeks post-randomisation, post-intervention, and at 6 and 12 months follow-up using a Global Assessment of Impairment/Improvement Scale.

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026