Condition category
Mental and Behavioural Disorders
Date applied
23/03/2017
Date assigned
14/04/2017
Last edited
05/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Social anxiety disorder, also known as social phobia, is a common type of anxiety disorder, in which a person feels a persistent and overwhelming fear of social situations. The symptoms can range from very mild to so severe that it causes major problems in day-to-day life. Social anxiety disorder often starts during adolescence and is particularly common in this age group. Although the number of adolescents with social anxiety is similar to the number with Mild Intellectual Disabilities (MID), there is a lack of studies looking at adolescents with anxiety disorders. There is a general conclusion is that treatments for anxiety are even less effective in individuals with MID compared to individuals with an average IQ. The aim of this study is to develop a training program to help reduce social anxiety symptoms in adolescents with MID.

Who can participate?
Adolscents with MID who are suffering from social anxiety.

What does the study involve?
Participants are randomly allocated to one of two groups. Each group takes part in five 20-30 minute training sessions on a computer at their school. The training involves different scenarios for each group. In the first group, the scenarios are related to social situations and have a positive ending. In the second group, the scenarios are non-emotional and end in a neutral way that is irrelevant to anxiety. At the beginning of the study, directly following training, and 10 weeks later, participants in both groups preform a range of tasks and questionnaires in order to assess their social anxiety.

What are the possible benefits and risks of participating?
Adolescents may benefit from an improvement to their social anxiety symptoms. In addition, participants receive a voucher as a reward for completing each study procedure. There are no notable risks involved with participating.

Where is the study run from?
Eight secondary schools in the Netherlands (Netherlands)

When is the study starting and how long is it expected to run for?
April 2015 to September 2016

Who is funding the study?
1. 's HeerenLoo (Netherlands)
2. Antonia Wilhelmina Fonds (Netherlands)
3. VU Amsterdam (Netherlands)

Who is the main contact?
1. Dr Mariët van der Molen (scientific)
2. Dr Anke Klein (scientific)
3. Dr Elske Salemink (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mariët van der Molen

ORCID ID

Contact details

Klinische Ontwikkelingspsychologie
De Boelelaan 1091
Amsterdam
1081 HV
Netherlands

Type

Scientific

Additional contact

Dr Anke Klein

ORCID ID

Contact details

Department of Developmental Psychology
Universiteit van Amsterdam
Nieuwe Achtergracht 129B
Amsterdam
1018 WS
Netherlands

Type

Scientific

Additional contact

Dr Elske Salemink

ORCID ID

http://orcid.org/0000-0002-6885-2598

Contact details

Department of Developmental Psychology
Universiteit van Amsterdam
Nieuwe Achtergracht 129B
Amsterdam
1018 WS
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KLEIN17MID

Study information

Scientific title

In socially anxious adolescents with mild intellectual disabilities, does cognitive bias modification for interpretation (CBM-I) reduce interpretation biases and social anxiety?

Acronym

Study hypothesis

Adolescents in the positive CBM-I training group would show significant reductions in interpretation biases and self-reported social anxiety after training, compared to adolescents in the neutral CBM-I training group.

Ethics approval

Faculty Ethics Review Board (FMG-UvA) of the University of Amsterdam, 17/08/2015, ref: 2015-DP-4592
(Amendment approved 20/10/2015)

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

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

Condition

Social anxiety

Intervention

A sample of approx. 700 - 750 adolescents will be recruited from secondary schools for students with mild to borderline intellectual disabilities in the Netherlands. After passive consent is granted by the adolescents and their parents, adolescents will participate in the screening part of this study. Directly following screening, adolescents scoring above the clinical cut-off score on the social phobia subscale of the SCARED-NL-71 during the screening, will be selected to attend the training. Selected adolescents (and their parents) will receive an information letter with an invitation to participate in the study. The letter explains the study in detail and both the adolescent and their parents give approval to participate in the training. After active consent is signed, adolescents will be randomly allocated to either the positive training or the neutral control-training. Participant numbers will be allocated before the screening phase started. Allocation to training type will be based on participant number; even numbers receive the neutral training, uneven numbers receive the positive training (simple randomization). The research assistants on the project will enroll the participants and assign the participants to the intervention.

After randomization, adolescents will be invited to an assessment session in which they perform the IREC-T, the AST and the SASC-R individually in a testing room at their own school. They will then receive five training sessions in three weeks time individually in a separate room at their own school. Each training session, performed on a school computer, will take about 20-30 minutes and participants will be able to take short breaks after every 10 scenarios. Directly following the last training session and during the 10-week-follow-up, the participants will perform the assessment session including the IREC-T, the AST and the SASC-R again. A trained Master’s level student in Developmental Psychology accompanies all session.

To modify interpretation bias, adolescents will complete a training program of 5 sessions in a three-week period. Each session consists of 40 ambiguous scenarios. Each scenario consists of three short sentences, with one word in the last sentence missing. Two different versions of the training task will be created, a positive training and a neutral control-training. In the positive training (intervention), all ambiguous scenarios will be related to social situations and the word fragment will make the story end positively. In the control training, all ambiguous scenarios will be non-emotional and the word fragment will make the story end in a neutral non-emotional way that is irrelevant to anxiety.

All participants preform the baseline (approximately 3 days pre-training), 3 (post-training) and 10 weeks (follow up) assessments.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Social anxiety symptoms (reported by children) are measured using the Social Anxiety Scale for Children – Revised and the the social phobia subscale of the SCARED-NL-71 at baseline (pre-training), 3 (post-training) and 10 weeks (follow up)
2. Social anxiety symptoms (reported by one of the parents and the teacher) are measured using the Social Anxiety Scale for Children – Revised and the social phobia subscale of the SCARED-NL-71 at baseline, 3 and 10 weeks
3. Interpretation bias is measured with the Ambiguous Scenarios Task (AST) and the Interpretation Recognition Task (IREC-T) at baseline, 3 and 10 weeks

Secondary outcome measures

1. State anxiety during the training as measured with a state anxiety list at baseline, 3 and 10 weeks
2. Interference and attention bias as measured with the original STROOP and an Emotional STROOP tests at baseline, 3 and 10 weeks
3. Total level of anxiety is measured with the SCARED 41 questionnaire at baseline, 3 and 10 weeks
4.Aggression is measured with the Reactive-Proactive aggression scale (RPQ) at baseline, 3 and 10 weeks
5. Attention control is measured with the Attention Control Scale (ACS) at baseline, 3 and 10 weeks
6. Motivation to partake in the training and to change social anxiety symptoms are measured using interview questions at baseline, 3 and 10 weeks

Overall trial start date

15/04/2015

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 12-18 years
2. Mild intellectual disability (IQ 60-85)
3. Scoring above the clinical cut-off score on the social phobia subscale of the SCARED-NL-71

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/09/2015

Recruitment end date

01/05/2016

Locations

Countries of recruitment

Netherlands

Trial participating centre

Scholengemeenschap W.J. Bladergroen
Flevostraat 257
Purmerend
1442 PX
Netherlands

Trial participating centre

Praktijkschool Westfriesland
Gording 124
Hoorn
1628 HG
Netherlands

Trial participating centre

Praktjikschool de Brug
Saenredamstraat 39
Assendelft
1566 KL
Netherlands

Trial participating centre

Praktijkcollege De Atlant
Teilingen 4
Amsterdam
1082 JS
Netherlands

Trial participating centre

Futura College
Abeellaan 2
Woerden
3442 JB
Netherlands

Trial participating centre

Luca Praktijkschool
Javaplantsoen 24
Amsterdam
1095 CS
Netherlands

Trial participating centre

Emaus College
Groene Allee 120
Ermelo
3853 JW
Netherlands

Trial participating centre

Oost ter Hout
Oosterhoutlaan 19
Haarlem
2012 RA
Netherlands

Sponsor information

Organisation

VU University

Sponsor details

De Boelelaan 1105
Amsterdam
1081 HV
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

's HeerenLoo

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Antonia Wilhelmina Fonds

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

VU Amsterdam

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Anke Klein (a.m.klein@uva.nl)

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes