Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity

Child Abuse Clinical Trial

Official title:

Cognitive Bias Modification Training in Adolescents Who Have Experienced Adversity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625206
• Other study ID #: PAHBABR
• Status: Completed
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: May 17, 2020

Study information

• Verified date: August 2020
• Source: Institute of Psychiatry, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 17, 2020
• Est. primary completion date: May 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Abuse
• Child Neglect
• Victimization

Intervention

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
• Control training
These exercises are matched to the task demands of the modules of cognitive bias modification training

Locations

Country	Name	City	State
India	Psychology Department	Varanasi
Nepal	Psychology Department, Tribuwan University	Kathmandu

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Psychiatry, London	Banaras Hindu University, Tribhuvan University, Nepal

Countries where clinical trial is conducted

India,  Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Symptoms of emotional, behavioural and social problems	5 subscales of the Strength and Difficulties questionnaire	Immediately after the intervention (post-intervention)
Secondary	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)
Secondary	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)