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

NCT03086876 | Completed DMC

• 1 other identifier: 15/162/02
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Challenging Behaviour

Outcome Measures

Primary Outcomes (1)

• Child Behaviour Check List (CBCL)

  Children's challenging behaviour will be measured at 12 months post randomisation using the parent completed preschool Child Behaviour Checklist (CBCL)

  12 months

Secondary Outcomes (10)

• Revised Family Observation Schedule (FOS-RIII)

  12 months

• Child Behaviour Checklist Caregiver-Teacher Report Forms (C-TRF)

  12 months

• General Health Questionnaire (GHQ)

  12 months

• Questionnaire on Resources and Stress (QRS-F short form)

  12 months

• Caregiving Problem Checklist-Difficult Child Behaviour

  12 months

Study Arms (2)

Stepping Stones Triple P

EXPERIMENTAL

Trained practitioners will deliver Level 4 SSTP to parents in 6 weekly group sessions and will also provide 3 telephone of face to face contacts to each participant but they will not be involved in routine care for participants in either arm. Each therapist responsible for delivering SSTP will be trained in the Group Stepping Stones Training and Accreditation programme which includes three training days and a further half day accreditation workshop after 6 weeks. The group sessions not only educate but actively train the parents in skills and the individual consultations aim to facilitate independent problem solving. The learning objectives focus on maintaining behavioural change, using skills within a group learning environment, learning from peers in the group and sharing difficulties or achievements, providing support, considering if more intensive work is required, referring further if needed, talking about risk and protective factors operating within families.

Behavioral: Level 4 Stepping Stones Triple P (SSTP)

Treatment as usual (TAU)

NO INTERVENTION

TAU will be available to participants in both arms of the trial. It may include a range of services such as: 1\. Health visitor services; 2. Primary care engagement and advice; 3. Potentially some version of early intervention maybe provided by either community paediatric services or Child and Adolescent Mental Health Services, although our understanding is that very little is available for children of this age. 4. Parenting advice and support sessions by carers groups or other third sector organisations. Parents allocated to TAU will receive a list of national and local resources and the Contact a Family guide to challenging behavior with tips and advice on social and health care supports.

Interventions

Level 4 Stepping Stones Triple P (SSTP) BEHAVIORAL

Stepping Stones Triple P is a system of psychoeducational and behavioural approaches to parenting a child with LD and challenging behaviour that aims to increase parental confidence and skills so that parents are able to manage the child's behavior effectively. SSTP comprises different levels based on increasing family complexity.

Stepping Stones Triple P

Eligibility Criteria

• Age: 30 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: Parents 18 years or over; Child aged 30-59 months at identification;
• Child has moderate to severe intellectual disability (parent reported Adaptive Behaviour Assessment System (ABAS) General Adaptive Functioning 20-69);
• Written informed consent by parent/caregiver;
• Reports of challenging behaviour over a 6-month period but no less than 2 months.

You may not qualify if:

• Child has mild, profound or no LD on parent reported ABAS;
• Parent/carer has insufficient English language to complete study questionnaires;
• Another sibling is taking part in the study.

Sponsors & Collaborators

• University College, London: lead

Study Sites (4)

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, United Kingdom

Location

Central and North West London NHS Foundation Trust

London, United Kingdom

Location

Guy's and St Thomas NHS Foundation Trust

London, United Kingdom

Location

Northumberland, Tyne and Wear NHS Foundation Trust

Newcastle, United Kingdom

Location

Related Publications (3)

• Ondruskova T, Oulton K, Royston R; EPICC-ID Research Group; Hassiotis A. Process evaluation of a parenting intervention for pre-schoolers with intellectual disabilities who display behaviours that challenge in the UK. J Appl Res Intellect Disabil. 2024 Sep;37(5):e13263. doi: 10.1111/jar.13263.

  PMID: 39045819 DERIVED

• Ondruskova T, Royston R, Absoud M, Ambler G, Qu C, Barnes J, Hunter R, Panca M, Kyriakopoulos M, Oulton K, Paliokosta E, Sharma AN, Slonims V, Summerson U, Sutcliffe A, Thomas M, Dhandapani B, Leonard H, Hassiotis A. Clinical and cost-effectiveness of an adapted intervention for preschoolers with moderate to severe intellectual disabilities displaying behaviours that challenge: the EPICC-ID RCT. Health Technol Assess. 2024 Jan;28(6):1-94. doi: 10.3310/JKTY6144.

  PMID: 38329108 DERIVED

• Farris O, Royston R, Absoud M, Ambler G, Barnes J, Hunter R, Kyriakopoulos M, Oulton K, Paliokosta E, Panca M, Paulauskaite L, Poppe M, Ricciardi F, Sharma A, Slonims V, Summerson U, Sutcliffe A, Thomas M, Hassiotis A. 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. BMC Psychiatry. 2020 Jan 30;20(1):35. doi: 10.1186/s12888-020-2451-6.

  PMID: 32000729 DERIVED

Study Officials

• Angela Hassiotis

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: June 1, 2017
• Primary Completion: December 17, 2021
• Study Completion: March 31, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

GB (4)