Skip to content

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

Online Parent Training for the Initial Management of ADHD Referrals: A two-arm parallel randomised controlled trial of a digital parenting intervention implemented on a treatment waitlist

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16523503
Enrollment
352
Registered
2021-11-18
Start date
2022-05-09
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

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

Interventions

Participants (n=352) will be randomised to either the intervention or the wait-as-usual group using online randomisation system provided by Sealed Envelope. Measure will be taken at baseline (T1), sch
WAU): Those randomised to WAU will receive STEPS (for 3 months) after they have completed the 12-month follow-up. In the sites across our trial centres, we do not expect any patients to receive their

Sponsors

King's College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Current secondary outcome measures as of 12/09/2022: 1. Mean parent-rated child hyperactivity/impulsivity and inattention measured using the respective subscale of the Swanson, Nolan, and Pelham Rating Scale – the MTA version measured at baseline, 3 months and 12 months post-randomisation 2. Parenting style measured with the laxness and overactivity subscales of The O’Leary Parenting Scale measured at baseline, 3 months and 12 months post-randomisation 3. Parenting satisfaction and efficacy measured using the Parental Sense of Competence scale measured at baseline, 3 months and 12 months post-randomisation 4. Parenting-related strain measured using the Caregiver Strain Questionnaire measured at baseline, 3 months and 12 months post-randomisation 5. Child-parent closeness measured with a subscale from the Child-Parent Relationship Scale measured at baseline, 3 months and 12 months post-randomisation 6. Children’s and parents’ health-related quality of life. The former will be measured with the Child Health Utility measure (CHU9D) and the latter with the EQ-5D-5L. Measures will be taken at baseline, 3, 6, 9 and 12 months post-randomisation Exploratory outcomes: 1. Mean rating of child oppositional and defiant speech during an online parent-child drawing task, Etch-a-Sketch Online, measured with independent observer ratings on Childhood Oppositional and Defiance Speech Sample Scale at baseline, 3 months and 12 months post-randomisation 2. Mean parent-rated child emotional problems measured with the respective subscale of the Strengths and Difficulties Questionnaire at baseline, 3 months and 12 months post-randomisation 3. 3. Whether children had received a diagnosis/been prescribed medication extracted from medical records at 12 months follow-up _____ Previous secondary outcome measures: 1. Mean parent-rated child hyperactivity/impulsivity and inattention measured using the respective subscale of the Swanson, Nolan, and Pelham Rating Scale – the MTA version measure

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026