REaCH; a “Befriending” intervention, was provided to the pass out students of Deen Dayal Upadhyaya Grameen Kaushalya Yojana (DDU-GKY) centre of Rajagiri College of Social Sciences (RCSS), in Kerala, India. DDU-GKY is an initiative of the Ministry of rural development (MoRD), Government of India (GOI), which was launched in 2014 (http://ddugky.gov.in). The objective of this initiative is to add diversity to the incomes of the rural poor families and to cater to the career aspirations of rural youth. The focus of this project is rural youth aged 15 to 35 years from poor families. DDU-GKY has its branches in 28 States of India. Currently, there are 1,575 projects being implemented by over 771 partnering institutions. The aim of the intervention is to provide additional social support through the development of a non-judgmental, affirming, emotion-focused relationship over time that is provided free of cost by the DDU-GKY staff.
The REaCH intervention was designed to reduce depression and promote wellbeing through mobilization of social support from significant others, family and friends. It aims to deliver a three phase intervention to pass out students of DDU-GKY centre of RCSS and to evaluate its effectiveness in modulating the depression and wellbeing. It also aims to estimate the importance of social support in mediating the positive and negative outcomes of health crises. Detailed study protocol is submitted for publication separately (Reference Number: TRLS-D-20-01106).
We conducted an exploratory trial of REaCH intervention, between 29th July, 2020 and 26th August, 2020. The trial randomized participants to a structured befriending intervention or a general enquiry phone call based on computer generated random numbers. There will be two data collection points; before treatment and one-month post baseline. REaCH intervention was motivated by the success of an empathetic engagement of the DDU-GKY staff of RCSS with their alumni in the context of lockdown due to Covid-19 pandemic. The purpose was to understand the varied concerns of students during COVID-19 lockdown. The feedback from the participants suggested that most of them were in need of some kind of support to cope up with the situation. Quantitative and Qualitative data collected from the students further informed the intervention components. We undertook further pilot work to align their needs and intervention components, to develop processes and to find the operational challenges.
The participants of this two armed pilot intervention study were recruited from Rajagiri DDUGKY centre. Broad inclusion criteria were used in the participant recruitment, i.e., the pass out students, who were already placed in some jobs or in search of jobs; currently working or not working were included in the study. The recruitment of participants happened with the baseline assessment using google forms. The follow-up assessment was done using the same instruments to evaluate the effectiveness of the telephonic befriending intervention program. Out of 1036 potential participants from the centre, 538 participants were excluded due to reasons such as not meeting the inclusion criteria or were not interested to participate in the study. Out of 498 students enrolled, 251 were randomized to the intervention group for the structured befriending intervention and general enquiry telephone call was provided for the rest. 439 (43%) respondents were included for the final analysis. Recruitment and intervention was conducted over a span of one month, where the end date of the pilot study was one month after the first session of the intervention (See Fig 1)
Training of the staff
An important feature of this study was task-sharing and task-shifting through rigorous training and systematic supervision. Intervention team consisted of staff who were part of DDUGKY Project for a minimum of one year. Prelude to the intervention, the REaCH intervention team staff received one day (6 hours) training. The training consisted of the content and process of intervention. In addition to the training, an intervention manual, video of the training material, audio clips of sample interviews and a module on frequently asked questions were provided to the REaCH intervention team. The intervention manual has guidelines on developing relationships with clients, introduction and orientation to befriending, management of participant distress, confidentiality and safety issues for both staff and participants. Training and discussions between the project team and the staff members were facilitated through online platforms.
Two-layer supervision was introduced to ensure fidelity to the protocol: In the first level, the staff was supervised by two non-medical mental health professionals (Psychiatric social worker and a Clinical psychologist) working in the agency. In the second level, the mental health supervision was performed through a Psychiatrist, two Psychiatric social workers and two Clinical psychologists from RCSS. Regular supervisory meetings were conducted once in a week to collect the feedback from the intervention providers.
Participants were randomly assigned in 1:1 ratio, via computer generated random number list for the structured telephone befriending intervention or general enquiry telephone calls. The odd numbers were allotted to the intervention arm and even numbers to the control arm. The principal investigator, trial team, trial manager and the staff members were blinded to the allocation codes during the trial. The recruitment was done by a computer technician. Randomization list was password protected and had not been shared with anyone involved in the study. Use of computer based data allocation helped in masking the outcomes from the intervention providers. The group allocation of the participants was masked by introducing general enquiry telephone calls with the control group. To eliminate contamination, we separated the structured intervention team and general enquiry team physically and concealed the group to which they belonged and the type of instruction they received. Lock down related social distancing and work from home mode of functioning of the staff made this masking easy. A committee of professionals and a team of researchers provided additional oversight to the trial.
Intervention arm: Structured Befriending Intervention
Semi-structured Intervention manual was used to allow sufficient flexibility to suit the needs of each participant. REaCH intervention consisted of three phases. In Phase 1, participants were assessed for various psycho-somatic and social indicators of distress such as sleep, appetite, interpersonal relationships, adjustments and work life to determine the level of disturbance. First level intervention consisted of proactive engagement and crisis intervention which focused on psycho-education, self-absorbing activity engagements and symptom based intervention. In phase 2, Brief problem-solving support oriented therapy was provided with specific focus on their current felt needs and problems. Prioritized needs were targeted through mobilization of untapped resources. Phase 3 focused on: assertive linkage with available community resources and introduce preventive strategies; linking them with employment opportunities and community resources; also to sensitize about mental health needs and psychological capacity building to deal with future challenges. These three phases of intervention were spread across four sessions of 30 min to 1-hour duration.
Control arm: General enquiry phone calls
Participants randomised to the control arm were not given any intervention. They received 4 general enquiry phone calls lasting 5 to 30 minutes. General inquiry dealt with precautions that need to be taken to protect themselves from the pandemic, and the ways of coping with the lockdown related issues. Main focus of the phone call was on psycho-education based inquiries on COVID-19. No specific training was given for the staff making the telephonic calls in the control arm.
Assessments and Procedures
For assessments, an online questionnaire of quantitative tools was prepared using Google forms, with a consent form appended to it. Participants accessed the survey links through online communication platforms like Email or WhatsApp. After accepting the informed consent sheet, the participants were auto directed to the demographic information questionnaire and other standardised tools in a sequential manner. Questionnaire included Patient Health Questionnaire (PHQ-9) , Multidimensional scale of perceived social support (MSPSS) , WHO- wellbeing index 5  and sociodemographics. These questionnaires were translated into the local languages and reverse-translated for accuracy. Detailed instructions and sufficient explanations were provided in the initial page of the online survey.
The demographic variables were age, gender, marital status, occupation, education level and colour of ration card. Presence of Depression was measured using the PHQ-9, with scores of 1-4, 5-9, 10-14, 15-19, 20-27 indicating minimal, mild, moderate, severe and extreme depressive symptoms. Wellbeing was measured using WHO-5. 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 best possible wellbeing. The MSPSS measured perceived social support from three sources: family, friends, and a significant other. This measure contains 12 questions which were rated in a 7-point scale as “Very Strongly disagree”, “Strongly disagree”, “Mildly disagree”, “Neutral”, “Mildly agree”, “Strongly agree”, “Very strongly agree”. The MSPSS yielded high internal consistency (α= 0.88), stability (yielded α= 0.85 after 3 months from first administration) and moderate construct validity as the SS scores were negatively correlated to anxiety (r= −0.18; p < 0.01) and depression scores . All the measures used were cross culturally validated for sensitivity and reliability [14-17]. Post-intervention follow-up assessment was carried out through an online platform link for both control and intervention arm. This used the same baseline survey assessment tools and was performed online.
A target sample size of 490 participants (245 in each group) was estimated to provide 85% power and to generate a two-sided p value of 0·05 (alpha=5%). Our study included 251 participants in the intervention and 248 participants in the control after randomization. At follow up, 251 from intervention and 188 from control, completed post assessment. All participants were included in the analysis according to their allocated group at randomisation. Statistical tests used a p value less than 0.05 for significance. All statistical analysis procedures were done using STATA 14 and R version 3.6.3. Baseline summary statistics (mean, standard deviation, percentage) were calculated based on groups. Chi-square tests, T-tests were performed to test the significance between the study variables. Odds ratio of the outcome variables for the post-assessment were calculated using logistic regression modelling and 95% confidence intervals were presented. We analysed descriptive summaries of socio-demographic aspects and the scores of Wellbeing -5, PHQ- 9 and MSPSS as the baseline and after a month.
No additional human resource expense was incurred for the study, as we have utilized the services of the existing staff of the project. The intervention development services and training of the staff was done voluntarily. The only additional cost was, the telephone and internet charges which was negligible as most of the staff have been subscribed to the unlimited outgoing call plan. The intervention manual and frequently asked questions were e-content, so printing and stationery costs were also minimal. Our account statement showed that only less than INR 20 (it is around one fourth of a US dollar) was spent on each student for the intervention.