Condition category
Mental and Behavioural Disorders
Date applied
23/05/2016
Date assigned
31/05/2016
Last edited
20/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
When a child has a behaviour problem, the first treatment that is usually tried is a parenting programme or sessions on child behaviour management techniques. These work for many people but they don’t work for everyone. Some children have what are called ‘hard to treat behaviour problems’. Currently, there is little research looking into how best to help these children. Some researchers think a therapy called ‘Child Psychotherapy’ might help. This is already available in the NHS, but the therapy itself takes a long time. This study is looking at a brief version of this Child Psychotherapy treatment so that children and their parents/carers don’t have to go to so many sessions. The aim of these study is to find out whether it is feasible to carry out a larger study investigating whether this brief version of Child Psychotherapy is better than the ‘usual treatment’ offered.

Who can participate?
Children aged 5-11 years old, and their main caregiver, who have been referred to CAMHS with a behaviour problem.

What does the study involve?
Participants are randomly allocated to one of two groups. The children (and their care givers) in the first group take part in 12 weekly 50 minute therapy sessions. The children (and their care givers) in the second group continue to receive usual care for the duration of the study. At the end of the study, the amount of participants who agreed to take part and those who completed the study are recorded.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The study is run from the Clinical Trials Unit at the University of Leeds (UK)

When is the study starting and how long is it expected to run for?
March 2016 to December 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Liz Graham
e.h.graham@leeds.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Sadie Reed

ORCID ID

Contact details

Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 113 3439421
TIGA-CUB@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

30713

Study information

Scientific title

Trial on Improving Inter-Generational Attachment for Children Undergoing Behaviour Problems

Acronym

TIGA-CUB

Study hypothesis

The aim of this study is to investigate the practicability of implementing a confirmatory, randomised controlled trial (RCT) comparing Child Psychotherapy (CP) to Treatment as Usual (TaU), as a second-line intervention for children aged 5-11 with treatment resistant conduct disorders and inter-generational attachment difficulties and for their primary carers.

Ethics approval

Yorkshire & The Humber - Bradford Leeds Research Ethics Committee, 17/03/2016, ref: 16/YH/0055

Study design

Interventional; Design type: Treatment, Psychological & Behavioural, Complex Intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Children, Primary sub-specialty: Neurosciences; UKCRC code/ Disease: Mental Health/ Behavioural syndromes associated with physiological disturbances and physical factors

Intervention

Participants will be randomised on a 1:1 basis to receive either Manualised Child Psychotherapy or Treatment as Usual.

Child Psychotherapy: Both the primary carer and child will each attend 12, weekly 50 minute therapy sessions, as prescribed by the TIGA-CUB Child Psychotherapy manual.

Treatment as Usual: Participants receive the usual care offered by local CAMHS teams. This treatment is likely to be highly diverse and may involve group and/or individual and/or primary carer and/or family based work, delivered by a range of practitioners from a variety of professional backgrounds and theoretical orientations.

Participants will be contacted for follow-up at 4 months post-randomisation.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Recruitment rate is measured by recording the proportion of dyads who consented to participate at the study end
2. Attrition rate is measured by recording the proportion of dyads completing the study out of those randomised to follow-up at the study end
3. Adherence is measured by recording the proportion of dyads randomised to the intervention arm successfully completing the required number of therapy sessions specified in the manual (or fewer, as determined by the CAPT) at the study end

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/03/2016

Overall trial end date

15/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 5-11 years old at baseline
2. Presenting to CAMHS, or re-referred within CAMHS, with a clinical conduct disorder (≥4 on Strengths and Difficulties (SDQ) conduct sub-scale)
3. Child’s current primary carer* has been offered a first line group or individual parenting programme or other structured parenting intervention in primary care or within CAMHS, and has attended at least one session, but the child’s conduct disorder persists and the child has been referred to CAMHS or re-referred within CAMHS for further treatment.

*The term ‘primary carer’ denotes the adult most involved in parenting the child.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Children with a clinical diagnosis of Autistic Spectrum Disorder (ASD), including Asperger’s
2. Children with a clinical diagnosis of severe Learning Difficulties (LD)
3. Children medicated for Attention Deficit Hyperactivity Disorder (ADHD), unless they have been on a stable medication dose for 3 months or more (children with un-medicated ADHD are eligible if other inclusion criteria met)
4. Looked After Children (LAC) (including adopted children):
4.1. who are not in kinship foster care or special guardianship, or
4.2. who are not in kinship foster care or special guardianship which is stable (> 6 months)
5. Children under/at risk of Safeguarding or Court procedures
6. Children whose primary carer has severe mental health difficulties, determined by usual CAMHS procedures using clinical judgement (baseline GHQ-12 will be monitored for primary carers with severe mental health difficulties not identified by CAMHS)
7. Sibling has been randomised to the TIGA-CUB trial (as CP involving two CAPTs, which would be required for two children, may not be available in some of the services involved in the trial)
8. Primary carer is actively receiving a parenting programme within CAMHS for the child’s sibling
9. Primary carer lacks capacity to comply with trial requirements, e.g. as a result of a LD, due to research burden or due to insufficient proficiency in English
10. Primary carer has severe adverse parental functioning e.g. alcohol dependence (≥20 on Alcohol-Use Disorders Identification Test) or drug dependence (≥3 on Drug Abuse Screening Test), determined by the study Researcher on initial screening visit

Recruitment start date

01/07/2016

Recruitment end date

31/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Clinical Trials Research Unit Leeds Institute of Clinical Trials Research
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

Leeds and York Partnership NHS Foundation Trust

Sponsor details

First Floor
South Wing
St Mary’s House
St Mary’s Road
Leeds
LS15 8ZB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of study results in a peer reviewed journal

IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/10/2016: The study contact has been changed from Ms Liz Graham to Dr Sadie Reed.