Child AbuseNCT03625206
Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity
A study testing Cognitive bias modification training in people with Child Abuse and Child Neglect, run by Institute of Psychiatry, London at 2 sites in 2 countries.
Trial summary
Adolescents who have experienced adversity (childhood maltreatment and other forms of broader victimisation experiences) will be randomly allocated to receive a 5-session cognitive bias modification training (with attention and interpretation bias modification modules) or a control condition. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Child Abuse, Child Neglect, Victimization
- What is being tested?
- Cognitive bias modification training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Apr 2018to 17 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents aged 12-18 years
- Adolescents who have experienced adversity (abuse, neglect) or broader victimisation experiences (conventional crime)
Who cannot join
- Adolescents who have difficulty reading or understanding what is being read to them
- Adolescents who are currently at-risk for self-harm
- Adolescents who are currently experiencing psychotic symptoms
- Adolescents who are currently experiencing high-level trauma symptoms
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Adolescents who have experienced adversity (childhood maltreatment and other forms of broader victimisation experiences) will be randomly allocated to receive a 5-session cognitive bias modification training (with attention and interpretation bias modification modules) or a control condition. Outcome measures include measures of cognitive biases and symptoms of psychopathology; in addition, in a subset of adolescents, brain activity data will be acquired. All adolescents will complete a feedback form, upon which acceptability of the intervention will be assessed.
Read the detailed description
Up to 80 adolescents aged 12-18 years who have experienced adversity (childhood maltreatment and other forms of broader victimisation experiences) from India and Nepal will be randomly allocated to receive a 5-session cognitive bias modification training (with attention and interpretation bias modification modules) or a control condition over a 2-week period.
Pre and post-assessment measures include measures of attention and interpretation biases and symptoms of internalising and externalising psychopathology. In addition, in a subset of adolescents, brain activity data acquired using EEG will be acquired either during resting or viewing emotional face stimuli. Data from these measures will be used to generate effect sizes of changes for each group as well as being used in a limited number of significance-testing analysis. All adolescents will complete a feedback form, upon which acceptability of the intervention will be assessed.
- Conditions
- Child Abuse, Child Neglect, Victimization
- Being tested
- Cognitive bias modification training, Control training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive bias modification trainingBehavioural
These training sessions aim to modify a selective attention bias towards threat and a tendency to interpret ambiguous situations in threatening ways
Control trainingBehavioural
These exercises are matched to the task demands of the modules of cognitive bias modification training
| Study group | Role | What they receive |
|---|---|---|
| Cognitive bias modification training | Experimental | Participants will receive 5 training sessions, each session including attention bias modification and interpretation bias modification training modules Receives: Behavioral: Cognitive bias modification training |
| Control training | Placebo comparator | Participants will receive 5 sessions that involve exercises that are matched to the task demands of the attention bias modification and interpretation bias modification training modules Receives: Behavioral: Control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention biases for threatening stimuli
The investigators will use an experimental measure (a visual search task) that uses reaction times (RTs) to different experimental conditions to index the degree to which attention is captured by a threatening over a non-threatening stimulus.
Measured: Immediately after the intervention (post-intervention)
Interpretation biases for threatening explanations
The investigators will use an experimental measure (an ambiguous scenarios task) that uses ratings to different experimental trials to index the degree to which individuals endorse threatening over benign interpretations
Measured: Immediately after the intervention (post-intervention)
Secondary outcomes (3)
Symptoms of emotional, behavioural and social problems
5 subscales of the Strength and Difficulties questionnaire
Measured: Immediately after the intervention (post-intervention)
Acceptability of intervention
The investigators have developed a 19-item self-report feedback, comprising quantitative ratings and qualitative responses. Across eleven items, young people rate on a 4-point Likert scale whether they found the training useful, satisfying, engaging, realistic, whether it impacted anxiety, mood, coping strategies, and other difficulties , and whether they would feel motivated to complete the sessions, including without a researcher present. Higher scores reflect greater endorsement. Each of these items will be reported separately rather than used to create composite scores. There are also 8 open ended questions for young people to leave their feedback on aspects they found helpful, unhelpful, liked, disliked, improvements they would want, and other general comments.
Measured: Immediately after the intervention (post-intervention)
Event related potentials to emotional face presentations during Electroencephalogram (EEG) experiment
P1, N1, P2, N2, P3 event-related potentials during face presentation
Measured: Immediately after the intervention (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start17 Apr 2018
- Primary completion17 May 2020
- Study completion17 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry, London
- Sponsor type
- University, hospital or other
- Collaborators
- Banaras Hindu University, Tribhuvan University, Nepal
- Responsible party
- Principal investigator, Jennifer Lau, Institute of Psychiatry, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625206
- Sponsor's protocol ID
- PAHBABR
- Status last verified
- Aug 2020
- First submitted
- 4 Jul 2018
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be anonymised such that each participant will be associated with a unique identification (ID) number. These will be uploaded to data repository sites once data collection, analysis and dissemination is completed
Publications
Dhakal S, Gupta S, Sharma NP, Upadhyay A, Oliver A, Sumich A, Kumari V, Niraula S, Pandey R, Lau JYF. Can we challenge attention and interpretation threat biases in rescued child labourers with a history of physical abuse using a computerised cognitive training task? Data on feasibility, acceptability and target engagement. Behav Res Ther. 2023 Mar;162:104267. doi: 10.1016/j.brat.2023.104267. Epub 2023 Jan 29.
PubMed 36780810
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity
- ClinicalTrials.gov ID
- NCT03625206
- Acronym / sponsor ID
- PAHBABR
- Conditions
- Child Abuse, Child Neglect, Victimization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institute of Psychiatry, LondonUniversity, hospital or other
- Collaborators
- Banaras Hindu University, Tribhuvan University, Nepal
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 17 May 2020 (actual)
- Study completion
- 17 May 2020 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescents who have experienced adversity (childhood maltreatment and other forms of broader victimisation experiences) will be randomly allocated to receive a 5-session cognitive bias modification training (with attention and interpretation bias modification modules) or a control condition. Outcome measures include measures of cognitive biases and symptoms of psychopathology; in addition, in a subset of adolescents, brain activity data will be acquired. All adolescents will complete a feedback form, upon which acceptability of the intervention will be assessed.
Detailed description
Up to 80 adolescents aged 12-18 years who have experienced adversity (childhood maltreatment and other forms of broader victimisation experiences) from India and Nepal will be randomly allocated to receive a 5-session cognitive bias modification training (with attention and interpretation bias modification modules) or a control condition over a 2-week period.
Pre and post-assessment measures include measures of attention and interpretation biases and symptoms of internalising and externalising psychopathology. In addition, in a subset of adolescents, brain activity data acquired using EEG will be acquired either during resting or viewing emotional face stimuli. Data from these measures will be used to generate effect sizes of changes for each group as well as being used in a limited number of significance-testing analysis. All adolescents will complete a feedback form, upon which acceptability of the intervention will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive bias modification training | Experimental | Behavioral: Cognitive bias modification trainingParticipants will receive 5 training sessions, each session including attention bias modification and interpretation bias modification training modules |
| Control training | Placebo comparator | Behavioral: Control trainingParticipants will receive 5 sessions that involve exercises that are matched to the task demands of the attention bias modification and interpretation bias modification training modules |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents aged 12-18 years
- Adolescents who have experienced adversity (abuse, neglect) or broader victimisation experiences (conventional crime)
Key exclusion criteria (4 listed)
- Adolescents who have difficulty reading or understanding what is being read to them
- Adolescents who are currently at-risk for self-harm
- Adolescents who are currently experiencing psychotic symptoms
- Adolescents who are currently experiencing high-level trauma symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive bias modification trainingThese training sessions aim to modify a selective attention bias towards threat and a tendency to interpret ambiguous situations in threatening ways | Behavioural | Cognitive bias modification training |
| Control trainingThese exercises are matched to the task demands of the modules of cognitive bias modification training | Behavioural | Control training |
Primary outcome
Attention biases for threatening stimuli
Time frame: Immediately after the intervention (post-intervention)
The investigators will use an experimental measure (a visual search task) that uses reaction times (RTs) to different experimental conditions to index the degree to which attention is captured by a threatening over a non-threatening stimulus.
Interpretation biases for threatening explanations
Time frame: Immediately after the intervention (post-intervention)
The investigators will use an experimental measure (an ambiguous scenarios task) that uses ratings to different experimental trials to index the degree to which individuals endorse threatening over benign interpretations
3 secondary outcomes
Symptoms of emotional, behavioural and social problems
Time frame: Immediately after the intervention (post-intervention)
Acceptability of intervention
Time frame: Immediately after the intervention (post-intervention)
Event related potentials to emotional face presentations during Electroencephalogram (EEG) experiment
Time frame: Immediately after the intervention (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Derived from this study: PubMed 36780810Dhakal S, Gupta S, Sharma NP, Upadhyay A, Oliver A, Sumich A, Kumari V, Niraula S, Pandey R, Lau JYF. Can we challenge attention and interpretation threat biases in rescued child labourers with a history of physical abuse using a computerised cognitive training task? Data on feasibility, acceptability and target engagement. Behav Res Ther. 2023 Mar;162:104267. doi: 10.1016/j.brat.2023.104267. Epub 2023 Jan 29.
- Individual participant dataSharing planned: Yes. All data will be anonymised such that each participant will be associated with a unique identification (ID) number. These will be uploaded to data repository sites once data collection, analysis and dissemination is completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive bias modification training in people with Child Abuse and Child Neglect, run by Institute of Psychiatry, London at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention biases for threatening stimuli (time frame: Immediately after the intervention (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03625206, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.