scholarly journals The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled treatment trial with an embedded stepped-wedge cluster randomized controlled recruitment trial

2018 ◽  
Author(s):  
Rachana Parikh ◽  
Rooplata Sahu ◽  
Christopher G Fairburn ◽  
Bruce Chorpita ◽  
Pim Cuijpers ◽  
...  
Keyword(s):  
Mental Health ◽  
Problem Solving ◽  
Controlled Trial ◽  
Adolescent Mental Health ◽  
New Delhi ◽  
Stepped Wedge ◽  
Mental Health Symptoms ◽  
Health Symptoms ◽  
Randomized Controlled ◽  
School Based

Abstract Background Conduct, anxiety and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention to improve mental health symptoms and recovery rates for school-going adolescents in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial. Methods We will conduct a two-arm individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health symptoms and associated impact. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention), or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported impact of mental health difficulties, perceived stress, mental wellbeing and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. Parallel process evaluation, including estimations of the costs of delivering the interventions, will be conducted. An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added impact of a classroom-based sensitization intervention over school-level recruitment sensitization activities on the primary outcome of referral rate (number of referred students as a proportion of the total sampling frame in each arm). Secondary outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms across the arms. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unbinding. Discussion Both trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for adolescents. Trial registration: Both trials are registered prospectively with the National Institute of Health registry (www.clinicaltrials.gov, registration numbers NCT03633916 and NCT03630471) Keywords: mental health, problem-solving, psychological treatment, stepped-wedge trial, adolescents, schools, randomized controlled trial, low- and middle-income countries, India.

scholarly journals The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled treatment trial with an embedded stepped-wedge cluster randomized controlled recruitment trial

2019 ◽  
Author(s):  
Rachana Parikh ◽  
Daniel Michelson ◽  
Kanika Malik ◽  
Sachin Shinde ◽  
Helen A. Weiss ◽  
...  
Keyword(s):  
Mental Health ◽  
Problem Solving ◽  
Mental Health Problems ◽  
Adolescent Mental Health ◽  
Health Problems ◽  
New Delhi ◽  
Mental Health Symptoms ◽  
Health Symptoms ◽  
Randomized Controlled ◽  
School Based

Abstract Background Conduct, anxiety and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial. Methods We will conduct a two-arm individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health symptoms and associated impact. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention), or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported impact of mental health difficulties, perceived stress, mental wellbeing and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. We will also complete a parallel process evaluation, including estimations of the costs of delivering the interventions. An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added impact of a classroom-based sensitization intervention over school-level recruitment sensitization activities on the primary outcome of referral rate into the host trial (i.e. the proportion of adolescents referred as a function of the total sampling frame in each condition of the embedded recruitment trial). Other outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms among referred adolescents in each condition. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unblinding. Discussion Both trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for common adolescent mental health problems.

scholarly journals The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Rachana Parikh ◽  
Daniel Michelson ◽  
Kanika Malik ◽  
Sachin Shinde ◽  
Helen A. Weiss ◽  
...  
Keyword(s):  
Mental Health ◽  
Problem Solving ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Adolescent Mental Health ◽  
Health Problems ◽  
Mental Health Symptoms ◽  
Health Symptoms ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial. Methods/design We will conduct a two-arm, individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9–12 with persistent, elevated mental health symptoms and associated distress/impairment. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention) or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported distress/impairment, perceived stress, mental wellbeing, and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. We will also complete a parallel process evaluation, including estimations of the costs of delivering the interventions. An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added effect of a classroom-based sensitization intervention over and above school-level sensitization activities on the primary outcome of referral rate into the host trial. Other outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms among referred adolescents in each condition. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unblinding. Discussion Both trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for common adolescent mental health problems. Trial registration Both trials are registered prospectively with the National Institute of Health registry (www.clinicaltrials.gov), registration numbers NCT03633916 and NCT03630471, registered on 16th August, 2018 and 14th August, 2018 respectively).

scholarly journals An Integrative Adapt Therapy for common mental health symptoms and adaptive stress amongst Rohingya, Chin, and Kachin refugees living in Malaysia: A randomized controlled trial

PLoS Medicine ◽  
2020 ◽  
Vol 17 (3) ◽  
pp. e1003073 ◽  
Author(s):  
Alvin Kuowei Tay ◽  
Hau Khat Mung ◽  
Mohammad Abdul Awal Miah ◽  
Susheela Balasundaram ◽  
Peter Ventevogel ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Mental Health Symptoms ◽  
Health Symptoms ◽  
Randomized Controlled

Impact of Meditation on Mental Health Outcomes of Female Trauma Survivors of Interpersonal Violence With Co-Occurring Disorders: A Randomized Controlled Trial

2015 ◽  
Vol 32 (14) ◽  
pp. 2139-2165 ◽  
Author(s):  
Mo Yee Lee ◽  
Amy Zaharlick ◽  
Deborah Akers
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Interpersonal Violence ◽  
Controlled Trial ◽  
Trauma Survivors ◽  
Meditation Practice ◽  
Trauma Symptoms ◽  
Mental Health Symptoms ◽  
Health Symptoms ◽  
Randomized Controlled

This study was a randomized controlled trial that examined the impact of meditation practice on the mental health outcomes of female trauma survivors of interpersonal violence who have co-occurring disorders. Sixty-three female trauma survivors were randomly assigned to the meditation condition and the control condition. Treatment conditions consisted of a 6-week meditation curriculum that was influenced by Tibetan meditation tradition and focused on breathing, loving kindness, and compassion meditation. Clients in the meditation condition made significant changes in mental health symptoms ( t = 5.252, df = 31, p = .000) and trauma symptoms ( t = 6.009, df = 31, p = .000) from pre-treatment to post-treatment, whereas non-significant changes were observed among the control condition clients. There were significant group differences between clients in the meditation condition and in the control condition on their mental health symptoms, F(1, 54) = 13.438, p = .001, and trauma symptoms, F(1, 54) = 13.395, p = .001, with a generally large effect size of eta squared .127 and .146, respectively. In addition, significantly more clients in the meditation condition achieved reliable change in mental health symptoms (35.5% vs. 8.3%) and trauma symptoms (42.3% vs. 4.8%) than clients in the control condition. Significance of the study is discussed with respect to the empirical evidence of meditation practice as a complementary behavioral intervention for treating female trauma survivors of interpersonal violence who have co-occurring disorders.

scholarly journals Integrating mental health and disaster preparedness in intervention: a randomized controlled trial with earthquake and flood-affected communities in Haiti

2019 ◽  
Vol 50 (2) ◽  
pp. 342-352 ◽  
Author(s):  
Leah Emily James ◽  
Courtney Welton-Mitchell ◽  
John Roger Noel ◽  
Alexander Scott James
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Natural Hazards ◽  
Disaster Preparedness ◽  
Health Workers ◽  
Controlled Trial ◽  
Mental Health Symptoms ◽  
Community Based ◽  
Health Symptoms ◽  
Randomized Controlled

AbstractBackgroundGiven the frequency of natural hazards in Haiti, disaster risk reduction is crucial. However, evidence suggests that many people exposed to prior disasters do not engage in disaster preparedness, even when they receive training and have adequate resources. This may be partially explained by a link between mental health symptoms and preparedness; however, these components are typically not integrated in intervention.MethodsThe current study assesses effectiveness of an integrated mental health and disaster preparedness intervention. This group-based model was tested in three earthquake-exposed and flood-prone communities (N = 480), across three time points, using a randomized controlled trial design. The 3-day community-based intervention was culturally-adapted, facilitated by trained Haitian lay mental health workers, and focused on enhancing disaster preparedness, reducing mental health symptoms, and fostering community cohesion.ResultsConsistent with hypotheses, the intervention increased disaster preparedness, reduced symptoms associated with depression, post-traumatic stress disorder, anxiety, and functional impairment, and increased peer-based help-giving and help-seeking. Mediation models indicated support for the underlying theoretical model, such that the effect of the intervention on preparedness was mediated by mental health, and that effects on mental health were likewise mediated by preparedness.ConclusionsThe community-based mental health-integrated disaster preparedness intervention is effective in improving mental health and preparedness among community members in Haiti vulnerable to natural hazards. This brief intervention has the potential to be scaled up for use with other communities vulnerable to earthquakes, seasonal flooding, and other natural hazards.

scholarly journals Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India

2021 ◽  
Vol 6 (6) ◽  
pp. e003902
Author(s):  
Rachana Parikh ◽  
Adriaan Hoogendoorn ◽  
Daniel Michelson ◽  
Jeroen Ruwaard ◽  
Rhea Sharma ◽  
...  
Keyword(s):  
Mental Health ◽  
Low Income ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
New Delhi ◽  
Stepped Wedge ◽  
Whole School ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionWe evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems.MethodsWe conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents.ResultsBetween 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001).ConclusionA single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India.Trial registration numberNCT03633916.

scholarly journals Efficacy of a Web-Enabled, School-Based, Preventative Intervention to Reduce Bullying and Improve Mental Health in Children and Adolescents: Study Protocol for a Cluster Randomized Controlled Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Covadonga M. Díaz-Caneja ◽  
Javier Martín-Babarro ◽  
Renzo Abregú-Crespo ◽  
Miguel Á. Huete-Diego ◽  
Marta Giménez-Dasí ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Bullying Victimization ◽  
Randomized Controlled ◽  
School Based ◽  
Cluster Randomized

Introduction: Bullying is a major preventable risk factor for mental disorders. Available evidence suggests school-based interventions reduce bullying prevalence rates. This study aims to test the efficacy of a web-enabled, school-based, multicomponent anti-bullying intervention to prevent school bullying and to assess its effects on mental health and quality of life.Methods and analysis: Cluster randomized controlled trial conducted in 20 publicly funded primary and secondary schools in Madrid, Spain. Schools are randomly allocated to either the intervention arm (n = 10) or conventional practices arm (n = 10). The web-enabled intervention (LINKlusive) lasts ~12 weeks and consists of three main components: (i) an online training program for teachers and parents, (ii) a web-guided educational program for students, focusing on promoting respect for diversity, empathy, and social skill development, and (iii) a web-guided, teacher-delivered, targeted intervention program for bullying situations identified based on peer-support strategies and individual intervention for those involved (i.e., bullying victims and perpetrators). The primary objective is to compare differences between peer-reported bullying victimization in the intervention and control arms at the end of the intervention. Secondary outcome measures are additional measures of bullying victimization and perpetration, mental health symptoms, self-esteem, and quality of life. A follow-up assessment is conducted 1 year after the end of the intervention. Treatment effects will be tested using multilevel mixed models, adjusting for school-, classroom-, and student-related covariates. Considering the increased bullying rates in children with special educational needs, a specific subgroup analysis will test the efficacy of the intervention on bullying prevalence, mental health, and quality of life in this particularly vulnerable population.Ethics and Dissemination: The Deontology Commission of the School of Psychology, Universidad Complutense in Madrid, Spain reviewed the study protocol and granted ethical approval on 21st January 2019. The results of the trial will be disseminated in relevant peer-reviewed journals and at conferences in the field.Trial Registration Number: ISRCTN15719015.

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