ASPECTS: Acute Stress Programme for Children and Teenagers
| ISRCTN | ISRCTN38352118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38352118 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/02/2010
- Registration date
- 05/05/2010
- Last edited
- 27/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Post-traumatic stress disorder (PTSD) is an anxiety disorder which can affect people following incidents such as road traffic accidents, assaults and natural disasters. This study is looking at a treatment for PTSD in children and young people who have recently experienced trauma. It is already known that the talking therapy Cognitive Behavioural Therapy (CBT) can help children and young people who have had PTSD for some time (chronic) but it is not known if it helps them in the acute (recent) stage. It is felt to be important to help children and young people in the early stages as the condition could become chronic and affect their development. The main aim of this study is to test the effectiveness of CBT as an early intervention for PTSD in children and young people. The researchers will also look at the course and prevalence of PTSD in the first 2 months after the traumatic event. Finally possible biological and psychological factors that may be associated with PTSD will be investigated.
Who can participate?
60 children and young people aged 8-17 who have experienced a road traffic accident, an assault or other single traumatic event and have a diagnosis of PTSD.
What does the study involve?
In the main study, participants are randomly allocated into two groups to either receive a course of up to 10 sessions of CBT or to be put on the waiting list. This allows the researchers to compare the differences between those who receive CBT and those that don’t (those on the waiting list who are still experiencing PTSD after 10 weeks will be offered CBT). Participants are recruited 2-4 weeks after the traumatic event and re-assessed after 2 months. Participants from the CBT group are also assessed after 6 and 12 months to see if any benefits are maintained. For the other parts of the study, two more groups of 60 children of similar age and gender are recruited. One group will have experienced a traumatic event but without developing significant PTSD symptoms and the other group will not have experienced trauma. Participants undergo a series of psychological and physical tests.
What are the possible benefits and risks of participating?
The study will provide important information about the development of PTSD in children and young people, what factors effect recovery and whether CBT is an appropriate early treatment. There were no major risks of participating.
Where is the study run from?
MRC Cognition and Brain Sciences Unit (UK)
When is the study starting and how long is it expected to run for?
May 2010 to August 2013
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Dr Richard Meiser-Stedman
richard.meiser-stedman@mrc-cbu.cam.ac.uk
Contact information
Scientific
MRC Cognition and Brain Sciences Unit
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
 ORCID ID |
0000-0002-0262-623X |
|---|---|
| Phone | +44 (0)1223 273624 |
| richard.meiser-stedman@mrc-cbu.cam.ac.uk |
Study information
| Study design | Single-centre single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Cognitive behavioural therapy (CBT) as an early intervention for post-traumatic stress disorder (PTSD) in youth: preliminary efficacy and mechanisms of action |
| Study acronym | ASPECTS |
| Study hypothesis | Is cognitive behavioural therapy (CBT) an efficacious early intervention for post-traumatic stress disorder (PTSD) in children and adolescents? This question will be addressed using a randomised controlled trial, where CBT is compared to a wait-list control group. |
| Ethics approval(s) | Cambridgeshire 1 Research Ethics Committee, 29/04/2010, ref: 10/H0304/11 |
| Condition | Post-traumatic stress disorder (PTSD) |
| Intervention | Participants will enter the trial at 2 - 3 months after a traumatic event. They will either be allocated to active treatment or a wait list. The experimental intervention will be a course of cognitive behavioural therapy (CBT). This will last for up to 10 sessions, and be delivered over a 10 week period. This treatment would be based largely on the treatment package devised for a previous trial of CBT for chronic PTSD in children and adolescents. Each session will last 60 - 90 minutes. The control intervention will be a 10 week wait list group, with the same pre- and post-intervention assessments as the experimental intervention. Post-treatment assessments will be conducted by doctoral-level psychologists blind to treatment allocation. Participants who still have PTSD at the end of the wait list period will be offered the CBT treatment. Total duration of treatment for CBT will be 10 - 15 hours, over 10 weekly sessions; follow ups will take place at 6 months and 12 months post-treatment. |
| Intervention type | Other |
| Primary outcome measure | 1. PTSD status, as assessed using the Children's PTSD Inventory (CPTSDI) 2. Child PTSD Symptom Scale (CPSS) All of the primary and secondary outcome measures will be completed at the pre- and post-treatment assessments; all primary and secondary measures will be completed at the 6- and 12-month follow ups, with the exception of the Clinician's Global Assessment Scale. |
| Secondary outcome measures | 1. Mood and Feelings Questionnaire (MFQ) 2. Spence Childrens Anxiety Scale (SCAS) 3. Childrens Global Assessment Scale (CGAS) All of the primary and secondary outcome measures will be completed at the pre- and post-treatment assessments; all primary and secondary measures will be completed at the 6- and 12-month follow ups, with the exception of the Clinician's Global Assessment Scale. |
| Overall study start date | 01/05/2010 |
| Overall study end date | 01/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Exposure to a road traffic accident, an assault, or another discrete traumatic stressor (i.e. any event that involve the threat of death, severe injury, or threat to bodily integrity, or witnessing such an event) 2. Aged 8 - 17 years, either sex 3. Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic criteria for PTSD, or the alternative algorthim for children and young people proposed by Scheeringa and colleagues (Scheeringa, Wright, Hunt, & Zeanah, 2006), assessed by a structured interview 4. The index trauma occurred 2 - 3 months prior to trial entry |
| Participant exclusion criteria | 1. Intellectual disability (i.e. mental retardation) 2. Another primary psychiatric diagnosis 3. PTSD following another previous trauma 4. Unconscious for greater than 15 minutes following the traumatic event 5. Not being fluent in English 6. Ongoing exposure to threat 7. History of organic brain damage 8. Significant risk of self-harm |
| Recruitment start date | 21/02/2011 |
| Recruitment end date | 01/08/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
CB2 7EF
United Kingdom
United Kingdom
Sponsor information
Research council
MRC Cognition and Brain Sciences Unit
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
| anthea.hills@mrc-cbu.cam.ac.uk | |
| Website | http://www.mrc-cbu.cam.ac.uk/ |
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Analysis is completed, awaiting publication |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2017 | Yes | No |
Editorial Notes
27/03/2018: Publication reference added.
26/02/2016: Plain English summary added.
