OPTIMA: A randomised controlled trial to evaluate a digital intervention (STEPS) designed to provide parenting support during the wait for child and adolescent mental health service assessment

Not Applicable

Conditions: Children’s behaviour problems
Mental and Behavioural Disorders
Attention deficit hyperactivity disorder

Registration Number: ISRCTN16523503

Lead Sponsor: King's College London

Brief Summary: 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36510236/ (added 13/12/2022)

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 352

Inclusion Criteria

1. Parents of all new referrals of children aged 5 years 0 months to 11 years and 11 months that have been accepted onto the assessment waiting list and the referred child (optional). A ‘new referral’ is defined as a child who has been on a waiting list for assessment for no longer than nine calendar months.
2. Parents aged 18 years or older: confirmed through screening.
3. Child scored > = 8/10 on the hyperactivity/inattention and >= 4/10 on the conduct problems subscale of the SDQ, established through screening medical records. These cut-offs identify the top 10% of the population.
4. English language competence: parent confirms through screening.
5. Access to a STEPS compatible mobile device (iOS 9.0 or later; Android 4.1 or later) with access to the internet (i.e., mobile internet or wi-fi).; parent confirms through screening.

Exclusion Criteria

1. Child living under local authority care; confirmed through screening medical records.
2. Child completed clinical assessment; confirmed through screening medical records and discussion with parents (e.g., in case of privately obtained diagnosis/treatment).
3. Child started a pharmacological or non-pharmacological treatment for ADHD; confirmed through screening medical records.

If two children from the same family are referred during the trial at the same time and both meet inclusion criteria, then only the older of the two will be included. If they are referred at different times the first child will be included.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parent-reported mean child behaviour problems measured with the eight-item ODD subscale of the Swanson Nolan and Pelham Rating Scale at 3 months post randomisation

Secondary Outcome Measures