Condition category
Mental and Behavioural Disorders
Date applied
22/09/2010
Date assigned
01/10/2010
Last edited
31/08/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.incredibleyearscymru.org

Contact information

Type

Scientific

Primary contact

Dr Tracey Bywater

ORCID ID

Contact details

School of Psychology
Nantlle Building
Normal Site
Bangor University
Bangor
LL57 2PX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Funder ref: C1119A1193; UKCRN ID: 8615

Study information

Scientific title

Building Social and Emotional Competence in Young High-Risk School Children: A Pragmatic Randomised Controlled Trial of the Incredible Years Therapeutic (Small Group) Dinosaur Curriculum in Gwynedd Primary Schools, Wales

Acronym

Study hypothesis

The primary research question is:
1. Does small group coaching in the Therapeutic Dinosaur curriculum to groups of 6 high-risk 4-8 year old children attending schools where the classroom version of the same curriculum is also being delivered, provide added benefits to these children?

Secondary questions include:
2. For which children is the intervention most effective?
3. What are the environmental/contextual circumstances that improve the likelihood of success?
4. Do parents and teachers perceive similar behaviour patterns in the children at each time point, i.e. if positive behavioural changes are found in school following participation in the intervention do they generalise to the home?
5. Does the duration of time participating in an intervention affect likelihood of success, that is, is there a dosage affect?
6. Can the intervention be implemented efficiently and effectively with fidelity by teachers in mainstream schools?
7. Does the intervention impact on teachers’ mental health?

Ethics approval

1. The School of Psychology Ethics Review Committee, Bangor University approved on the 1st March 2010 (ref: 1506)
2. North Wales Research Ethics Committee (West) approved on the 17th September 2010 (ref: 10/WNo01/55)

Study design

Single centre single blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Conduct disorder, social and emotional wellbeing

Intervention

The Incredible Years Therapeutic (small Group) School-Based Programme includes; how to do your best in school and learn school rules, understanding, identifying, and articulating feelings, problem solving, anger management, how to make and keep friends. It is an 18-24 week programme delivered in weekly 2-hour sessions with groups of six children. This programme will be delivered to the waiting list control children after the first follow-up. Intervention participants in Phase 1 schools will have three data collection points - baseline and 8 and 16 months post baseline. Intervention participants in Phase 2 schools will only have baseline and 8-month follow up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The teacher-completed Strengths and Difficulties Questionnaire (SDQ) to assess total child difficulties.
We shall also analyse the subscales of conduct, peer relationships and hyperactivity problems, social competence, and the impact supplement, which assesses the impact behaviour can have in other areas of life.
The score for borderline 'abnormal' behaviour is 12 for total difficulties –the higher the score the worse the problems. This measure will be administered at baseline, and the 8- and 16-month follow-ups.

Secondary outcome measures

All measures are collected at baseline, 8 and 16 month follow-ups (unless stated otherwise).

1. Parent reports on child behaviour include:
1.1. The parent-completed Strengths and Difficulties Questionnaire (SDQ) to assess total child difficulties.
We shall also analyse the subscales of conduct, peer relationships and hyperactivity problems, social competence, and the impact supplement, which assesses the impact behaviour can have in other areas of life.
It has 25 items, as does the teacher SDQ, but differs in scores for borderline ‘abnormal’ behaviour which is 14-16 as compared to 12-15 for teacher SDQ.
1.2. The 36-item Eyberg Child Behaviour Inventory (ECBI) to assess child problem behaviours on the index child.
Each behaviour is rated on two scales: a 7-point Intensity scale that measures how often the behaviour is perceived to occur, ranging in response intensity from 1 (Never) to 7 (Always); and a Yes-No Problem scale that identifies whether the behaviour is currently seen as a problem for the parent.
1.3. A demographics questionnaire will be administered at baseline to assess background family characteristics; a follow-up version will be administered at both follow-ups to establish any factors that may impact on the results.
1.4. Dina Questionnaire to establish any changes in behaviours specifically targeted by the intervention.
Parents are asked about their child’s use of 10 specific behaviours taught in Dinosaur School.
Scoring:
Never – 0; Rarely = 1; Sometimes = 2; Often = 1; Always = 4, scores are summed to give each participant a total. A higher total score suggests a bigger social and emotional problem.

2. Parent self-reports include:
2.1. Becks Depression Inventory (BDI, Beck et al., 1961), 21-item tool to assess characteristic attitudes and symptoms associated with depression.
The co-occurrence of maternal depression and child conduct problems is well documented. The total score provides an index of overall severity of depression.
Score 0 - 13 = minimal
Score 14 -19 = mild
Score 20 - 28 = moderate
Score 29 - 63 = severe
2.2. Warwick Edinburgh Mental Well-being Scale (WEMBS) to assess levels of wellbeing.
The higher the score the higher the level of wellbeing. No cut-offs. The WEMWBS is a 14 item positively worded item scale with five response categories from ‘none of the time’ to ‘all of the time’.
2.3. Arnold O’Leary Parenting Scale. to assess parenting competencies.
There is no cut-off but the higher the score on the 7-point likert scale the less competent, or skilled, the parent.

3. Teacher self-reports include:
3.1. Teacher background questionnaire (baseline only) provides information on teachers' qualifications and experiences
3.2. Teacher Stress Inventory Modified version (TSI; Boyle, Borg, Falzon, & Bagiloni, 1995)
Teachers with a high total score experience greater stress than those with a lower score. It is a 20-item tool.

4. Child completed measures include:
4.1. Wally problem solving task (Webster-Stratton & Reid, 2001) to assess the children's problem solving skills or solutions in response to hypothetical problem situations.
The Wally Problem Solving Task is researcher administered, where the researcher presents 13 illustrated problem situations to the to assess the child’s ability to problem-solve the scenario. Responses are rated according to their content using pre-determined response codes. An example problem item includes: Suppose you ask another friend to play with you and she refuses. What would you do? Responses to situations are rated as positive (asking for a reason), negative (claiming for self), neutral (ignore), pro-social (help to repair) or agonistic (aggressive) responses.

5. Independent assessments:
5.1. Observation of child in class on behaviour relating to core programme components (measure under development during Phase 1, to be used as an assessment tool for Phase 2 participants). Assesses the core elements of Dina Programme:
5.1.1. Making new friends
5.1.2. Detecting and understanding feelings
5.1.3. How to do your best in school
5.1.4. Problem solving steps
5.1.5. How to be friendly
5.1.6. How to talk to friends
5.2. Attendance levels of child participants and their class teachers via school records
5.3. Academic Attainment via school records

Overall trial start date

10/10/2010

Overall trial end date

30/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. The index child will be rated by their teacher as within the borderline to ‘abnormal’ range or above on the screening measure - Teacher Strengths & Difficulties Questionnaire (SDQ)2. The child will be 4 - 8 years of age
3. The child and parent speak Welsh and/or English
4. The parent reads (or is read) the information sheet, understands the trial and consents to:
4.1. Their child attending the programme
4.2. Their child being observed
4.3. Their child completing a Wally problem solving task and being recorded
4.4. Completing questionnaires about themselves and their child
4.5. Their child being randomly allocated to an early or later group
4.6. The group being filmed for supervision purposes - whilst the camera is trained on the facilitators, their child may be in frame
4.7. Their child to be audio-taped during the Wally problem-solving task
4.8. Their child’s school academic and attendance records being accessed

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

240 children and 240 primary carers, teachers of child participants (N TBC)

Participant exclusion criteria

1. The child does not reach at least the ‘borderline’ range on the SDQ Total Difficulties Score
2. The child is the incorrect age
3. The parents do not consent
4. Parent and child do not speak either Welsh or English

Recruitment start date

10/10/2010

Recruitment end date

30/05/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychology
Bangor
LL57 2PX
United Kingdom

Sponsor information

Organisation

Bangor University (UK)

Sponsor details

School of Psychology
Brigantia
College Rd
Bangor
LL57 2DG
United Kingdom
+44 (0)1248 383670
psychology@bangor.ac.uk

Sponsor type

University/education

Website

http://www.bangor.ac.uk/psychology/

Funders

Funder type

Industry

Funder name

The Big Lottery (UK) - (ref: C1119A1193)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21314913

Publication citations

  1. Protocol

    Bywater T, Hutchings J, Whitaker C, Evans C, Parry L, The Incredible Years Therapeutic Dinosaur Programme to build social and emotional competence in Welsh primary schools: study protocol for a randomised controlled trial., Trials, 2011, 12, 39, doi: 10.1186/1745-6215-12-39.

Additional files

Editorial Notes