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Supporting Toddlers with a family connection to autism or ADHD to develop strong Attention, Regulation and Thinking skills (START) programme

Feasibility randomized controlled trial of the Supporting Toddlers with a family connection to autism or ADHD to develop strong Attention, Regulation and Thinking skills (START) programme: a comparison between START and Usual Practice

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99820028
Enrollment
60
Registered
2023-01-30
Start date
2023-02-13
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Development of executive functions in toddlers with a family connection to autism or ADHD Mental and Behavioural Disorders

Interventions

Participants will be randomised on a 1:1 basis using an online tool to receive either the START intervention or the Usual Practice. START is a manualised programme comprising 12 weekly 1-hour group se

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The child participant must have either of the following: 1.1. At least 1 first-degree relative with a community diagnosis (as reported by the parent) OR 1.2. At least 1 first-degree relative with presumed autism who scores above the clinical threshold on an autism screening measure OR 1.3. At least 1 first-degree relative with presumed ADHD who scores above the clinical threshold on an ADHD screening measure OR 1.4. Has been identified by their parent, or health or Early Years practitioner as showing high autistic traits 2. Is aged 20 months or less at the time of the eligibility screen, and older than 20 months at the time of the final scheduled intervention start date

Exclusion criteria

Exclusion criteria: 1. Significant uncorrected visual or hearing problems 2. A known genetic condition associated with developmental delay (e.g. fragile X syndrome, Down’s syndrome, neurofibromatosis type 1, tuberous sclerosis complex); note that an existing diagnosis of autism is not an exclusion criterion for the study 3. Currently placed in a 24-hour residential placement or a foster placement due to end before the 36-month follow-up data collection point 4. Any parent in their family has already participated in the START trial 5. They or any parent in their family has participated in a research trial involving a parenting intervention or other EF-related intervention (i.e. via an Early Childhood Education and Care setting) within 3 months of the baseline assessment, or during the course of the START trial

Design outcomes

Primary

MeasureTime frame
Parent report of Executive Functions measured using the Behaviour Rating Inventory of Executive Function, Preschool Version (BRIEF-P) questionnaire at baseline, endpoint (4-11 months) and follow-up (16 months)

Secondary

MeasureTime frame
1. Parent report of Executive Functions measured using the Early Executive Functions Questionnaire (EEFQ) at baseline, endpoint (4-11 months) and follow-up (16 months) 2. Secondary-carer report of Executive Functions measured using BRIEF-P questionnaire at follow-up (16 months) 3. Problem-solving ability measured using the Problem-Solving Box task at baseline, and follow-up (16 months) 4. Executive function performance measured using a battery of tasks at baseline, and follow-up (16 months) 5. Parent report of psycho-social difficulties measured using the Strengths & Difficulties Questionnaire (SDQ) at follow-up (16 months)

Countries

England, United Kingdom

Contacts

Public ContactSTART Study Team
start@psy.ox.ac.uk+44 (0)73108 76421

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026