Preventing preschool externalising behaviour problems: A cluster controlled trial evaluating the 'Toddlers Without Tears' parenting program delivered at age 8-15 months
| ISRCTN | ISRCTN77531789 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77531789 |
| Secondary identifying numbers | ACTRN12606000239561 |
- Submission date
- 06/09/2004
- Registration date
- 04/11/2004
- Last edited
- 26/10/2009
- 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 Harriet Hiscock
Scientific
Scientific
Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
| Phone | +61 (0)3 9345 6150 |
|---|---|
| harriet.hiscock@rch.org.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Scientific title | |
| Study acronym | TWT - Toddlers Without Tears |
| Study objectives | Preschool child externalising behaviour problems including aggression, opposition and hyperactivity. 1. At age 18 months: 1.1. Decreased incidence of externalising behaviours 1.2. Decreased prevalence of harsh and abusive parenting 1.3. Increased prevalence of warm and developmentally appropriate parenting 1.4. Decreased prevalence of maternal depression/anxiety 2. At age 24 months: 2.1. Sustained improvement in child behaviour, parenting and maternal wellbeing 3. An increase in knowledge, competency and confidence of Maternal and Child Health nurses in delivering anticipatory guidance for behaviour problems in young toddlers |
| Ethics approval(s) | Ethics approval received from the Ethics in Human Research Committee (EHRC) (ref: 24020A) |
| Health condition(s) or problem(s) studied | Behavioural disorders |
| Intervention | Cluster randomised controlled trial, cluster at the level of the well-child centre. Masking occurred at randomisation, with group allocation concealed from researchers and participants until allocation was complete. Arm A: Parenting program (one individual 15-minute and two 2-hour group sessions) about normal child development, ways to encourage desirable behaviour and ways to manage misbehaviour in toddlers. Strategies derived from systematic reviews of parenting programs for treating established child externalising behaviour problems. Program delivered by maternal and child health nurses and co-facilitated by parenting experts. Arm B: Usual care provided by nurses at well-child visits (active control) |
| Intervention type | Other |
| Primary outcome measure | Primary outcome 1: Parent-reported child behaviour problems on the Child Behaviour Checklist (Achenbach & Rescorla, 2000). Measured at 18 months, 24 months and 3 years. Primary outcome 2: Parent-reported parenting practices on the Parent Behaviour Checklist (subscales: developmental expectations, nurturance, harsh discipline) (Fox, 1994). Measured at 18 months, 24 months and 3 years. Primary outcome 3: Parent-reported mental health on the Depression Anxiety Stress Scales (Lovibond & Lovibond, 1995). Measured at 18 months, 24 months and 3 years. |
| Secondary outcome measures | Economic evaluation (cost consequences) of cost of delivering the intervention and costs of other sevrices used by families for either the child's behaviour and/or the mother's mental health. Timepoint: At 18, 24 and 36 months. |
| Overall study start date | 01/12/2001 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | Target sample size 370. Recruitment status achieved n = 734 |
| Key inclusion criteria | Eligible participants were parents of children aged 6 months attending community well-child clinics across 6 Melbourne local government areas during August/September 2004. Families were recruited from a broad sociodemographic sample. |
| Key exclusion criteria | Parents with insufficient English to attend a parenting group and complete brief written questionnaires. |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- Australia
Study participating centre
Centre for Community Child Health
Melbourne
3052
Australia
3052
Australia
Sponsor information
Murdoch Children's Research Institute (Australia)
Research organisation
Research organisation
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
| Phone | +61 (0)3 8341 6211 |
|---|---|
| julia.malone@mcri.edu.au | |
"ROR" |
https://ror.org/048fyec77 |
Funders
Funder type
Charity
Philanthropic Organisation (Australia)
No information available
William Buckland Foundation (Australia)
No information available
Telstra Community Development Fund (Australia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/02/2008 | Yes | No | |
| Results article | results | 01/03/2010 | Yes | No |
