NCT03086876

Evaluation of Parent Intervention for Challenging Behaviour in Children With Intellectual Disabilities (EPICC-ID)

Completed NA Last updated 21 April 2022

What this trial tests

NA trial testing Level 4 Stepping Stones Triple P (SSTP) in Challenging Behaviour in 261 participants. Completed in 31 March 2022.

Timeline

1 June 2017

Primary endpoint
17 December 2021

31 March 2022

Quick facts

Lead sponsor	University College, London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	261
Start date	1 June 2017
Primary completion	17 December 2021
Estimated completion	31 March 2022
Sites	4 locations across United Kingdom

Drugs / interventions tested

• Level 4 Stepping Stones Triple P (SSTP)

Conditions studied

• Challenging Behaviour — all drugs for Challenging Behaviour →

Sponsor

University College, London

Who can join

Adults 30 Months to 59 Months, any sex, with Challenging Behaviour. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities.The trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual (TAU) whilst the TAU group receive available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data is also being collected to carry out a cost effectiveness and utility evaluation. Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical and cost effectiveness of a parent mediated intervention to reduce challenging behaviour in pre-schoolers with moderate to severe intellectual disability (EPICC-ID) study protocol: a multi-centre, parallel-group randomised controlled trial.
   Farris O, Royston R, Absoud M, Ambler G, et al · · 2020 · cited 6× · PMID 32000729 · DOI 10.1186/s12888-020-2451-6
2. Evaluation of adapted parent training for challenging behaviour in pre-school children with moderate to severe intellectual developmental disabilities: A randomised controlled trial.
   Royston R, Absoud M, Ambler G, Barnes J, et al · · 2024 · cited 3× · PMID 39137195 · DOI 10.1371/journal.pone.0306182
3. Clinical and cost-effectiveness of an adapted intervention for preschoolers with moderate to severe intellectual disabilities displaying behaviours that challenge: the EPICC-ID RCT.
   Ondruskova T, Royston R, Absoud M, Ambler G, et al · · 2024 · cited 2× · PMID 38329108 · DOI 10.3310/jkty6144
4. Process evaluation of a parenting intervention for pre-schoolers with intellectual disabilities who display behaviours that challenge in the UK.
   Ondrušková T, Oulton K, Royston R, EPICC‐ID Research Group, et al · · 2024 · cited 1× · PMID 39045819 · DOI 10.1111/jar.13263