Aim
The aim of the befriending intervention is to promote mental wellbeing and reduce depressive symptoms by assisting participants to mobilize social support from family, friends and significant others.
The objectives of this trial are:
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To proactively engage with students to hear their concerns in a non-judgmental manner and empathize with them.
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To reassure students and get them back to work/ find a job and normal patterns of life, as early as possible
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To create a database of students who have either lost their jobs or are in search of jobs and link them to the job market.
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To facilitate active linkage with various formal and informal resources to reduce their distress
Design
Cluster Randomised controlled trial
Outcomes
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Mental wellbeing measured by World Health Organization-Five Well-being Index (WHO-5) [21, 22]
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Depressive symptoms measured by the Patient Health Questionnaire (PHQ-9) [23].
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Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS-12) [24]
Study location
For feasibility reasons, recruitment will be restricted to 6 geographical zones of India. These divisions are selected in consultation with Director of National Institute for Rural Development and Panchayat Raj (NIRDPR), training head, and her team. This clustering was done to capture the sociocultural and economic variations in settings and population and to address the needs specific to each zone. Table 1 lists the states that fall under each zone.
Table 1
List of states that fall under each zone.
Geographical zones
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States in the zone
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1. Northern zone
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Delhi, Himachal Pradesh, Jammu & Kashmir, Punjab, Uttarakhand, Uttar Pradesh
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2. North-East zone
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Assam, Arunachal Pradesh, Manipur, Meghalaya, Mizoram, Nagaland, Sikkim, Tripura
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3. Central zone
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Madhya Pradesh, Chattisgarh
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4. Eastern zone
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Bihar, Jharkhand, Odisha, West Bengal
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5. Western zone
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Goa, Gujarat, Maharashtra
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6. Southern zone
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Andhra Pradesh, Karnataka, Kerala, Puducherry, Tamil Nadu, Telangana
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Recruitment of clusters (PIAs)
Two project implementing agencies (PIA) will be recruited from each of the six zones (12 PIAs in total). For a PIA to be included in this study, it should be in one of the six zones and should be an active, currently operational PIA with a full-time staff. A computer-generated randomisation procedure will be used by the NIRDPR to select the PIAs in the six zones. The NIRDPR will contact only those agencies meeting the inclusion criteria, and invite them to be a part of the study. Six of the selected PIAs will be allocated to the intervention arm and 6 PIAs will be allocated to the control arm. Information on the number of full-time staff, contact details of passed out students will be collected by the State monitoring agencies.
Duration
The total duration of the trial is four weeks. The trial will run parallelly across all six zones. The expected duration of involvement of each participant is 1 month.
Recruitment of participants within PIAs
We will recruit 120 passed out youth from each participating PIA (total= 1440). All participants from one PIA will be either in the intervention arm or control arm. The participants are aged between 18-35, all genders, and up skilled in different domains. Participants will be invited to take part in baseline assessment and intervention programs.
Inclusion criteria
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Alumni students of the DDU-GKY program, who are either working or are in search of a job
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Own a smartphone
Exclusion criteria
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Do not possess a smartphone
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Unable to operate a smartphone
Randomisation and blinding
Following the completion of the baseline assessment for all participants, the eligible participants will be randomised at 1:1 ratio to one of the two arms (intervention or control) by the trial manager based on the PIA to which they belong. Computer-generated random number list will be created by a computer technician and odd numbers on the list will be allocated to the intervention arm and the even numbers will be allocated to the control arm.
Design measures to avoid bias
The allocation codes will be concealed by the use of a computer-generated random number list. The principal investigator, the trial team, trial manager or staff members will be blind to the allocation codes during the trial. The control arm will also receive general enquiry phone calls that will further help in masking the allocation. To avoid contamination, we will physically separate the intervention team and the control team, and blind the telephone support person (staff) about which arm they belong to. We believe the lockdown and work from home will assist in masking. Separate staff will make the phone calls in the intervention and control arms.
Assessments and procedures
Baseline assessments will be administered to all participants through an online survey by the research team. Questionnaires include PHQ-9, MSPSS, WHO-5 and socio-demographics. These questionnaires will be translated into the local languages and back-translated for accuracy. Detailed instructions and sufficient explanations will be provided on the initial page of the online survey.
The PHQ-9 questionnaire will be used to measure depression, with scores of 1-4, 5-9, 10-14, 15-19, 20-27 indicating minimal, mild, moderate, moderately severe and severe depressive symptoms. WHO-5 questionnaire will be used to measure wellbeing and the total row score (ranging from 0 to 25) is multiplied by 4 to provide the final score. 0 represents the worst possible wellbeing and 100 represents the best possible wellbeing. The MSPSS will be used to measure perceived social support from three sources: family, friends, and a significant other. This measure contains 12 questions which are rated on a 7-point scale as ‘very strongly disagree’, ‘strongly disagree’, ‘mildly disagree’, ‘neutral’, ‘mildly agree’, ‘strongly agree’, and ‘very strongly agree’.
Post-intervention follow-up assessment will be carried out through telephone for both control and intervention arm. This will use the same baseline survey assessment tools and will be performed online.
Training of the staff
The chief Executive officer and the chief operating officer/ State program manager from the six selected PIAs (12 in total) will be trained by the expert resource persons on content, process and strategies of the intervention manual. Training of trainers will be given to 36 facilitators, 6 members each from 6 intervention PIAs and the State Rural Livelihood Mission (SRLM) from the selected States. A virtual master class will be held to train these facilitators on providing the intervention (telephonic befriending). This training will last for approximately six hours and will include a session on question and answers. Following this training, the training video, protocol booklet, and frequently asked Q&As will be shared with the facilitators. Additionally, an online support centre will be set-up for continuous support to the trainers.
The trained facilitators will train 6 PIA staff (two from each agency) and each trained PIA staff will train an average of 6 other staff members. Staff who are a part of the DDU-GKY project for one year or longer will be trained to deliver the intervention. Staff who are a part of the intervention team will only receive this training on the intervention module. These trained staff members will reach out to 720 DDU-GKY alumni through this intervention.
Each befriender will be allocated between 10 to 15 students in their PIA. A 6-hour virtual training is designed for the staff, covering the components to be delivered during each session. An intervention manual for the training has been developed, which was also translated into the local language. After the training has been completed, the trained staff will be provided with the intervention manual, online video of the training session with subtitles, audio clips of sample interview content and a module on frequently asked questions. The intervention manual includes guidelines on developing a relationship with the client, introduction and orientation of participant to befriending, management of participant distress, confidentiality and safety issues for both staff and participants.
Separate staff members will be involved in the intervention arm and control arm. No specific training will be given for the staff making the telephonic calls in the control arm. They will provide general information about the precautions that need to be taken to protect themselves from the infection, and inquire about how the family is coping with the lockdown related issues.
Intervention
The two arms of the trial are:
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Telephone befriending intervention arm (n= 720)
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General enquiry phone call arm (control) (n=720)
Intervention arm: Telephone befriending intervention
This involves participants receiving befriending from trained DDU-GKY staff, through one-to-one phone calls which they will receive in their homes, at a time convenient to them. The telephonic befriending intervention will be conducted in three phases: (i) Proactive engagement and crisis intervention, (ii) Problem-solving oriented support therapy and (iii) Assertive linkage with community resources (see table 1). The three phases will spread across four phone calls for 30 minutes to 1-hour duration. Participants will be contacted by their telephone support person, and an introductory session will be arranged over the phone at each participants’ convenient time to establish a rapport.
Table 2
Three phases of the structured befriending intervention
Phase
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Objectives
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Interventions
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Phase 1: Proactive engagement and crisis intervention
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— To provide emotional support
— To provide strategies to alleviate distress and crisis
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In this session the befriender will:
— Establish a positive and supportive relationship with the participant,
— Provide emotional support
— Psycho-education about COVID-19 including precautionary measures,
— Enquire about general health and biological functioning.
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Phase 2: Problem-solving oriented supportive therapy
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— To provide strategies to solve client’s problems
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This includes five general stages:
— Problem orientation: Helping participant to identify the most distressing problem
— Problem definition and formulation: defining the problem based on its impact on day to day functioning
— Generation of alternatives: Helping the participant to identify alternative options
— Assist the decision-making
— Propose strategies to implement
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Phase 3: Assertive linkage with community resources
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— To utilize community resources for the well-being
— To solve a crisis like job loss, financial insecurity, etc.
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In this session, the befriender will:
— Provide practical support and information;
— Emphasize on social support and will provide strategies to improve it,
— Reassurance to the participant before termination of the session.
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During the telephone calls, a semi-structured questionnaire will be used to gather information on the stressors and risk factors in the context of this pandemic outbreak. Telephonic conversations will be recorded with the consent of the participants and later transcribed by the research team. The specific domains that will be assessed include the situational stressors in the context of COVID-19 outbreak and the different support mechanisms available to manage the difficulties. The staff will be trained to encourage the participant to speak about their issues and difficulties in the present context and empathetically listen to their worries.
Control arm: General enquiry phone calls
Participants randomised to the control arm will not be receiving any intervention. However, they will participate in a baseline and follow up assessment using the same instruments. They will receive 4 general enquiry phone calls lasting 5 to 30 minutes. It will be a general inquiry about the precautions that need to be taken to protect themselves from the infection, and how the family is coping with the lockdown related issues. The main focus will be given on psycho-education based inquiries on COVID-19.
Data entry and data management
The online data collection tool was developed and was linked to the dedicated server kept in the research centre. The participant will enter the data directly to the online mobile portal which will upload the data directly onto the research server. The stored data set and codes will be protected using a password by the trial manager, who is independent of the trial team. The centrally stored data will be cleaned and analysed by the research team under the supervision of the trial manager and the trial manager will verify the results independently to ensure the accuracy of the results. Data will be re-identified to ensure the confidentiality of information. Major findings of the study will be reported in scientific journals and will be presented in conferences and workshops. Interested researchers can contact the Principal Investigator for further research collaborations.
Sample size and statistical analysis
A target sample size of 1440 participants (720 in each arm) with less than 5% loss to follow up after one moth of intervention estimated to have 80% power. All participants will be included in the analysis according to their allocated group at randomisation. Statistical tests will use a p-value less than 0.05 for significance. All statistical analysis procedures will be done using STATA 14 and R version 3.6.3. Baseline summary statistics (mean, standard deviation, percentage) will be calculated based on groups. Chi-square tests, T-tests will be performed to test the significance of the study variables. The odds ratio of the outcome variables for the post-assessment will be calculated using logistic regression modelling and 95% confidence intervals. We will analyse descriptive summaries of socio-demographic aspects and the scores of WHO-5, PHQ- 9 and MSPSS as the baseline and after one month.