Preventing early anxiety disorders
| ISRCTN | ISRCTN30996662 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30996662 |
| Protocol serial number | N/A |
| Sponsor | National Health and Medical Research Council (NHMRC) (Australia) |
| Funder | National Health and Medical Research Council (NHMRC) (Australia) (ref: 607302) |
- Submission date
- 18/01/2010
- Registration date
- 18/03/2010
- Last edited
- 17/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jordana Bayer
Scientific
Scientific
Centre for Community Child Health
Royal Children's Hospital Melbourne
Flemington Rd
Parkville, Victoria
3052
Australia
| jordana.bayer@mcri.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Preventing early internalising problems in the preschool setting: a randomised controlled trial |
| Study objectives | This population-level randomised trial aims to test a preventive parenting program in the preschool setting for children systematically screened as at-risk of internalising problems due to temperamental inhibition. We hypothesise that: 1. Children whose parents enter the program will do better 12 and 24 months after baseline (the first two years of school for most) than control children on the study outcomes: 1.1. Fewer children with internalising disorders 1.2. Lower mean scores on early child internalising symptoms 1.3. Lower mean scores on harsh and overprotective parenting 1.4. Lower mean scores on parent internalising problems 2. The prevention program will be acceptable and cost-effective We will also examine differential effectiveness according to parent mental health and family level of disadvantage. |
| Ethics approval(s) | Royal Childrens Hospital Melbourne Ethics and Research Committee pending approval as of 20/01/2010 (ref: EHRC 21942). Estimated approval date is September 2010. |
| Health condition(s) or problem(s) studied | Child internalising (anxiety) problems |
| Intervention | Masking occurs at randomisation, with group allocation concealed from researchers and participants until allocation is complete. Arm A: Six-session group parenting program, delivered in the local community by an early childhood professional, focusing on ways to develop the child's bravery skills by reducing overprotective parenting interactions. Arm B: Usual care from the preschool, early childhood and health services in the community. Total duration of treatment: 2 - 3 months (6 x 90-minute group parenting sessions) Total duration of follow-up: 24 months post-baseline |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Child internalising diagnoses and symptoms at 12 and 24 months post-baseline. |
| Key secondary outcome measure(s) |
Evaluated at 12 and 24 months post-baseline: |
| Completion date | 30/04/2014 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 525 |
| Total final enrolment | 545 |
| Key inclusion criteria | 1. Parents of preschool children in their year before starting school in 2011 2. In four Melbourne local government areas 3. Children screened as temperamentally inhibited, either sex |
| Key exclusion criteria | Parents with insufficient English to participate |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 30/04/2014 |
Locations
Countries of recruitment
- Australia
Study participating centre
Centre for Community Child Health
Parkville, Victoria
3052
Australia
3052
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2018 | Yes | No | |
| Results article | 2-year follow-up results | 01/08/2020 | 30/11/2020 | Yes | No |
| Results article | follow-up results | 01/06/2021 | 17/06/2021 | Yes | No |
| Protocol article | protocol | 05/01/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/06/2021: Publication reference added.
30/11/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
16/05/2018: Publication reference added.
