Condition category
Mental and Behavioural Disorders
Date applied
21/02/2013
Date assigned
25/02/2013
Last edited
15/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The NSPCC has developed a course of therapy called ‘Letting the Future In’ (LTFI) for children and young people aged between 4 and 18 who have been affected by sexual abuse and are living with a carer who has been assessed as safe. The aims of this study are to determine the effectiveness, costs, strengths and weaknesses of LTFI, and to find out which groups of children benefit the most.

Who can participate?
Children aged between 4-17 years who have made a disclosure of sexual abuse and who have a safe carer who is willing to participate.

What does the study involve?
Participants are randomly allocated to either receiving the therapy immediately or after waiting for 6 months. They are offered up to 24 sessions with a trained social worker or therapist. LTFI also emphasises work with the child’s safe carer, who may receive up to six individual sessions as well as joint sessions with the child. Participants complete questionnaires when they join the study and after 6 and 12 months.

What are the possible benefits and risks of participating?
Participants allocated to the waiting list may experience an increase in anxiety and decline in mental health and if necessary can leave the study for immediate treatment.

Where is the study run from?
The School for Policy Studies, University of Bristol (UK).

When is the study starting and how long is it expected to run for?
February 2013 to February 2015.

Who is funding the study?
NSPCC (UK).

Who is the main contact?
Tricia Jessiman
Tricia.Jessiman@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Patricia Jessiman

ORCID ID

Contact details

School for Policy Studies
6-8 Priory Road
Clifton
Bristol
BS8 1TZ
United Kingdom
-
tricia.jessiman@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13718

Study information

Scientific title

Letting the Future In: therapeutic intervention for child sexual abuse - randomised trial

Acronym

Letting the Future In

Study hypothesis

The study will evaluate a therapeutic intervention for children affected by sexual abuse. The impact of the intervention on children and their 'safe carer' will be measured using validated measures in a before and after design with follow-up. In teams where demand for the service exceeds the team's capacity to deliver, the research design will take the form of a randomised trial with a waiting list control (RCT). Service use data will be collected from the safe carers as part of a cost-effectiveness analysis.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13718

Ethics approval

University of Bristol Faculty of Social Sciences and Law, 15/08/2012, ref: FSSLREC150812

Study design

Randomised trial with a waiting list control

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

Anxiety

Intervention

Letting the Future In: The intervention offers a therapeutic assessment followed by 20 individual sessions with the child or young person. (An additional 10 sessions may be negotiated with the team manager) and sessions with the 'safe carer'.

Follow Up Length: 6 month(s)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Trauma Symptoms Checklist (8-16) 54 items, self report (Briere et al. 1996); Timepoint(s): Baseline (T1), 6 months (T2), 12 months (T3)

Secondary outcome measures

1. Juvenile Victimisation Questionnaire (10 questions) (Finklehor et al. 2005); Timepoint(s): T1, T3
2. Parenting Stress Index - short form 36 items (Abidin, 1995); Timepoint(s): T1, T2, T3

Overall trial start date

01/02/2013

Overall trial end date

30/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male & Female; upper age limit 17 years, lower age limit 6 years
2. Intra- or extra-familial sexual abuse
3. Safe carer willing to collaborate in treatment

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 210

Participant exclusion criteria

Severe learning disability

Recruitment start date

01/02/2013

Recruitment end date

30/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 1TZ
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Level 6 Education Centre
Upper Maudlin Street
Bristol
BS2 8DJ
United Kingdom
-
research-governance@bristol.ac.uk

Sponsor type

University/education

Website

http://www.bris.ac.uk/

Funders

Funder type

Charity

Funder name

NSPCC (UK) - Grant Codes: ORCA 38414

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

01/06/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes