Investigating the effect of post-traumatic stress disorder on episodic memory of orphans

Last registered on January 09, 2024

Pre-Trial

Trial Information

General Information

Title
Investigating the effect of post-traumatic stress disorder on episodic memory of orphans
RCT ID
AEARCTR-0012799
Initial registration date
January 06, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
January 09, 2024, 11:50 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
Foundation university

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2023-12-22
End date
2023-12-31
Secondary IDs
Prior work
This trial is based on or builds upon one or more prior RCTs.
Abstract
study conducted was temporal study. The scientific method conducted throughout the study followed a double blinded experiment approach to eliminate biasness. Fifty participants were recruited from orphanages and schools in Rawalpindi, out of which 25 were children with parents that formed a control group and 25 were orphans that formed an experimenting group. To assess the intervention two blocks designed will be created in which participants will experience positive and negative interventions on Psychopy. The present study was approved by the ethics committee of Foundation University School of Science and Technology, Islamabad, Pakistan. All participants were fully informed regarding the study protocol and provided written informed consent.Inclusion criteria
A purposive sampling approach will be used to recruit participants from different orphanages. All potential participants are to be screened for eligibility by structural interview. After formal written consent is given by the caretakers, they will be randomized. Individual Capacity to provide inform consent is obtained informally from the orphanage staff. After consent is received, eligible participants are enrolled, and the assessment is completed. Eligibility criteria involves orphan children with PTSD aged 8 to 15 with basic knowledge of education.
Exclusion criteria
Individuals who refuse to participate and who are not educated were excluded from eligibility criteria.
External Link(s)

Registration Citation

Citation
Ahmed, Afeera. 2024. "Investigating the effect of post-traumatic stress disorder on episodic memory of orphans." AEA RCT Registry. January 09. https://doi.org/10.1257/rct.12799-1.0
Experimental Details

Interventions

Intervention(s)
• In the intervention is given in which exposure to a traumatic event is carried out to measure the memory through tasks in post-test. Through which it can be concluded episodic memory can be affected after the intervention and a well-defined difference between pretest and post-test is established.
Positive Intervention:
Will be related to trauma focused cognitive behavioral therapy. This includes different tasks that are being performed in the presence of the therapist. The positive intervention used is a positive video of a few seconds which will be shown to participants right after they are done with the tasks.
Negative Intervention:
The negative intervention that is used in this study is trauma exposure. The children will be exposed to many traumatic events. After they get triggered, the tasks will be performed again and then the results will tell the effect of negative and positive intervention on episodic memory of children with Post traumatic stress disorder.
Intervention Start Date
2023-12-22
Intervention End Date
2023-12-31

Primary Outcomes

Primary Outcomes (end points)
The study concluded that the negative intervention improved the performance of the orphan and normal children. In contrast, positive intervention reduced the performance of the orphan and normal children. There exists a significant difference between the Ptsd symptoms between normal and orphaned children.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The compensatory group had children with both parents. Initially, the experiment was performed on compensatory group by PTSD scale, Stroop Test, and task completion. After the initial screening negative intervention was presented to the compensatory group. Subsequently, a second screening procedure was performed, and positive intervention was given, followed by a final screening procedure. The results of screening were compared with each other to deduce the effect of positive and negative interventions.
The same process was carried out for the experimenting group that had orphan children.
The study concludes that there are notable disparities in cognitive performance and psychiatric symptoms, including indications of post-traumatic stress disorder (PTSD), between normal and orphan children in both compensatory and experimental groups. The orphan children's consistent high scores for PTSD symptoms in pre-, post-, and follow-up tests point to a greater and more persistent incidence of trauma-related symptoms in this population. Furthermore, the noteworthy variations in the Stroop test, Association task, and Storytelling task performances suggest that orphan children face cognitive difficulties, namely in areas pertaining to cognitive flexibility, attention, associative memory, and verbal memory abilities. The Matching exercise did not show any significant differences, which may indicate that certain areas of cognitive functioning are not as damaged or sensitive to the stress that orphan children suffer.
Experimental Design Details
Randomization Method
Block Randomization (Block size of 2) is performed using a computer-generated randomization list. 2 blocks were randomized simultaneously. Participants of control group and compensatory groups will be selected which includes orphan children from different orphanages and non-orphans from different schools.
Randomization Unit
School and orphanage
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
50
Sample size: planned number of observations
50 total from different school and orphanage
Sample size (or number of clusters) by treatment arms
25 normal children
25 orphan
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials