Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity

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.

Study Overview

• Status: Completed
• Conditions: Child Abuse; Child Neglect; Victimization
• Intervention / Treatment: Behavioral: Cognitive bias modification training; Behavioral: Control training

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Varanasi, India
    • Psychology Department
• Nepal
  • Kathmandu, Nepal
    • Psychology Department, Tribuwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adolescents aged 12-18 years
• Adolescents who have experienced adversity (abuse, neglect) or broader victimisation experiences (conventional crime)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive bias modification training; Participants will receive 5 training sessions, each session including attention bias modification and interpretation bias modification training modules	Behavioral: Cognitive bias modification training; These training sessions aim to modify a selective attention bias towards threat and a tendency to interpret ambiguous situations in threatening ways
Placebo Comparator: Control training; 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	Behavioral: Control training; These exercises are matched to the task demands of the modules of cognitive bias modification training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Immediately after the intervention (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of emotional, behavioural and social problems	5 subscales of the Strength and Difficulties questionnaire	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.	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	Immediately after the intervention (post-intervention)

Collaborators and Investigators

• Sponsor: Institute of Psychiatry, London
• Collaborators: Banaras Hindu University; Tribhuvan University, Nepal

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Actual): May 17, 2020
• Study Completion (Actual): May 17, 2020

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PAHBABR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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
• IPD Sharing Time Frame: Only once data collection, analysis and dissemination is completed
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No