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
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...
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| Format: | Article |
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BMC
2019-09-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3573-3 |
| _version_ | 1818495994076069888 |
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| author | Rachana Parikh Daniel Michelson Kanika Malik Sachin Shinde Helen A. Weiss Adriaan Hoogendoorn Jeroen Ruwaard Madhuri Krishna Rhea Sharma Bhargav Bhat Rooplata Sahu Sonal Mathur Paulomi Sudhir Michael King Pim Cuijpers Bruce F. Chorpita Christopher G. Fairburn Vikram Patel |
| author_facet | Rachana Parikh Daniel Michelson Kanika Malik Sachin Shinde Helen A. Weiss Adriaan Hoogendoorn Jeroen Ruwaard Madhuri Krishna Rhea Sharma Bhargav Bhat Rooplata Sahu Sonal Mathur Paulomi Sudhir Michael King Pim Cuijpers Bruce F. Chorpita Christopher G. Fairburn Vikram Patel |
| author_sort | Rachana Parikh |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-12-10T18:27:36Z |
| format | Article |
| id | doaj.art-6e953c894b2e4d0db12fb42064f791e1 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-10T18:27:36Z |
| publishDate | 2019-09-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-6e953c894b2e4d0db12fb42064f791e12022-12-22T01:38:02ZengBMCTrials1745-62152019-09-0120111810.1186/s13063-019-3573-3The 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 trialRachana Parikh0Daniel Michelson1Kanika Malik2Sachin Shinde3Helen A. Weiss4Adriaan Hoogendoorn5Jeroen Ruwaard6Madhuri Krishna7Rhea Sharma8Bhargav Bhat9Rooplata Sahu10Sonal Mathur11Paulomi Sudhir12Michael King13Pim Cuijpers14Bruce F. Chorpita15Christopher G. Fairburn16Vikram Patel17SangathSchool of Psychology, University of SussexSangathSangathMRC Tropical Epidemiology Group, London School of Hygiene & Tropical MedicineAmsterdam UMC, Amsterdam Public Health research institute, Vrije UniversitietAmsterdam UMC, Amsterdam Public Health research institute, Vrije UniversitietSangathSangathSangathSangathSangathDepartment of Clinical Psychology, National Institute of Mental Health and NeurosciencesDivision of Psychiatry, Faculty of Brain Sciences, University College LondonDepartment of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health research institute, Vrije Universiteit AmsterdamDepartment of Psychology, University of California, Los AngelesUniversity Department of Psychiatry, Warneford Hospital, OxfordSangathAbstract 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).http://link.springer.com/article/10.1186/s13063-019-3573-3Mental healthProblem-solvingPsychological interventionStepped-wedge trialAdolescentsSchools |
| spellingShingle | Rachana Parikh Daniel Michelson Kanika Malik Sachin Shinde Helen A. Weiss Adriaan Hoogendoorn Jeroen Ruwaard Madhuri Krishna Rhea Sharma Bhargav Bhat Rooplata Sahu Sonal Mathur Paulomi Sudhir Michael King Pim Cuijpers Bruce F. Chorpita Christopher G. Fairburn Vikram Patel 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 Mental health Problem-solving Psychological intervention Stepped-wedge trial Adolescents Schools |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Mental health Problem-solving Psychological intervention Stepped-wedge trial Adolescents Schools |
| url | http://link.springer.com/article/10.1186/s13063-019-3573-3 |
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