Cultural Adaptation and Feasibility Evaluation of Listen Protect Connect, A School-based Program of Psychological First Aid for School Students in Pakistan: A Cluster Randomized Control Trial

Last registered on May 26, 2022

Pre-Trial

Trial Information

General Information

Title
Cultural Adaptation and Feasibility Evaluation of Listen Protect Connect, A School-based Program of Psychological First Aid for School Students in Pakistan: A Cluster Randomized Control Trial
RCT ID
AEARCTR-0009496
Initial registration date
May 25, 2022

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
May 26, 2022, 11:45 AM EDT

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

Locations

Primary Investigator

Affiliation
Foundation University Islamabad

Other Primary Investigator(s)

Additional Trial Information

Status
In development
Start date
2022-05-30
End date
2023-02-06
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
School students are commonly exposed to traumatic and unforeseen tragic events which impact as many as 80% of the children worldwide. The reported prevalence rates of children's mental health problems in Pakistan are much higher (35%) than the global prevalence estimates of 10–20%. Considering the increasing prevalence of psychological disorders due to traumatic events among school students, this study proposes the implementation and adaptation of Listen Protect Connect (LPC) which is a school-based program of Psychological First Aid for primary and secondary school students. LPC program targets school students who have experienced any type of trauma. The distinguishing feature of this program is that it can be implemented by non-mental health professionals after they have received proper training from a mental health professional. The current study aims to translate and culturally adapt the LPC program and to carry out a feasibility evaluation of the program. Furthermore, this study will also evaluate the acceptability of the adapted version of the LPC program among schools in Pakistan by conducting a randomized controlled trial (RCT). The proposed study will use a cluster, double-blind, parallel two arm trial design. A sample of 64 students will be chosen from 8 schools located in Rawalpindi and Islamabad districts (8 students from each school, 4 in each arm). The schools will be randomized into intervention and control arms (1:1 allocation in each arm). The program will be implemented to the students allocated in the intervention group through the teachers (non-mental health professionals) who will receive proper training prior to the implementation. The teachers in the control arm will receive no training. The feasibility evaluation will demonstrate the significance of delivering the LPC program in schools in Pakistan. The primary outcome measures (exposure to trauma and psychological distress) will be evaluated through the Life Events Checklist (LEC) and Kessler Psychological Distress Scale (K6). Other scales will be used to assess the secondary outcomes of the study. The study results will demonstrate that embedding the LPC program within schools will be effective in fostering a continuum of improving the psychosocial health of students who are dealing with trauma in Pakistan.
External Link(s)

Registration Citation

Citation
Tariq, Anam. 2022. "Cultural Adaptation and Feasibility Evaluation of Listen Protect Connect, A School-based Program of Psychological First Aid for School Students in Pakistan: A Cluster Randomized Control Trial." AEA RCT Registry. May 26. https://doi.org/10.1257/rct.9496
Experimental Details

Interventions

Intervention(s)
Listen Protect Connect is a program of PFA which specifically targets school students who are at risk of developing mental disorders as a result of a traumatic event. This is 5 step program that requires proper 1-2 hours of training before implementation and it can be delivered by non-mental health professionals. LPC is a family or series of PFA strategies focusing on children, parents, families, and community members. LPC uses parents, teachers, primary care, and “neighbor-to-neighbor” providers to give basic psychological support Listen, Protect, Connect—Model & Teach,” (hereafter, LPC—Model & Teach) is a five-step crisis response strategy designed to reduce the initial distress of students or adults and to help students return to school, stay in school and resume their learning.8 It is not a single session recital of events, but a model that can guide the interactions of students and educators over time through the process of their recovery. Students may need to tell their stories many times in different settings (individually, in a small group, or after significant events that remind them of loss, the trauma, or the anniversary of the tragedy) or not tell their story at all depending on factors regarding the event and the characteristics of the student. Teachers, counselors, and other adults can use their discretion to apply these guiding principles in a flexible manner.
Intervention Start Date
2022-08-01
Intervention End Date
2022-08-29

Primary Outcomes

Primary Outcomes (end points)
The primary variables of the study are:
1. Exposure to Traumatic Event/s
2. Psychological distress
Primary Outcomes (explanation)
1. Exposure to Trauma:
To confirm exposure to trauma, students will be asked to report the types of trauma/s they have experienced, witnessed, or learned about through the Life Events Checklist (LEC). This self-report measure has adequate reliability and validity. Students will report their traumatic experiences on a 5-point scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = not sure, and 5 = does not apply)

2. Psychological Distress:
The interventionist will conduct a brief screening of non-specific distress using the six-item K6 screener (Furukawa et al. 2003) to measure psychological distress among students. Through this brief scale, interventionists will identify cognitive, physiological, and psychological reactions to trauma, and will engage in open discussion with the students about their fears and worries. Through assessment and honest discussion, the interventionist “protects” students by identifying potentially high-risk children who score high on the K6 screener or reveal maladaptive reactions to trauma.

Secondary Outcomes

Secondary Outcomes (end points)
The secondary outcomes of the study will be:
1. PTSD
2. Depression
3. Perceived Social Support
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Study design: Pre and Post Follow-up/Baseline design.
Trial design: A Parallel two-arm, Double-blind, feasibility cluster randomized controlled trial
Experimental Design Details
Not available
Randomization Method
Randomization is done in office by random number generator.
Randomization Unit
School
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
8 Schools from two cities in Pakistan.
Sample size: planned number of observations
64 School Students
Sample size (or number of clusters) by treatment arms
From each school, 8 students will be chosen and will be divided into 2 groups/arms (1:1 allocation in each arm):
Intervention group/arm= 32 students (4 students from each school)
Compensatory/control group/arm= 32 students (4 students from each school)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials

Documents

Document Name
Abstract of the Study
Document Type
proposal
Document Description
File
Abstract of the Study

MD5: b5a813d84dbe286be374dc8d9aad287e

SHA1: f2d28b26a0a7d63c21a4b4908454e91a324f5c59

Uploaded At: May 25, 2022

IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number