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 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 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 COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study – study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Secondary Outcome ◽  
Study Success ◽  
Randomized Controlled ◽  
Supported Education

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.

Living in Uncertain Times: Pre-existing Mental Health Symptoms, Intolerance of Uncertainty and Perceived COVID-19 Threat as Predictors of Psychological Distress During the Pandemic

2021 ◽  
Author(s):  
Kathryn M Bell ◽  
Diane Holmberg
Keyword(s):  
Mental Health ◽  
Psychological Distress ◽  
Mental Health Problems ◽  
Intolerance Of Uncertainty ◽  
Health Problems ◽  
Trauma Symptoms ◽  
Mental Health Symptoms ◽  
Distress Intolerance ◽  
Health Symptoms ◽  
Threat Levels

Amidst the ongoing COVID-19 pandemic, people are facing heightened uncertainty about the future and increasing rates of psychological distress. Intolerance of uncertainty (IU) and perceived COVID-19 threat may be contributing to mental health problems. This study investigated changes in mental health problems prior to and during the first two pandemic waves in the U.S., and the extent to which IU and perceived COVID-19 threat predicted these problems. MTurk participants (n=192; 50% women) were recruited from a pre-pandemic study in December 2019/January 2020 for a follow-up study on COVID-19 experiences, across five timepoints between April and August 2020. IU, perceived COVID-19 threat, and mental health problems (i.e., worry, COVID-19 fear, and trauma symptoms) were assessed. On average, mental health problems were not elevated, relative to pre-pandemic levels, and remained stable across time. Heightened IU and perceived COVID-19 threat were associated with more mental health problems. Surprisingly, objective measures of COVID-19 threat (e.g., state case rates) showed no associations with IU, and were slightly negatively correlated with psychological distress and perceived threat. Pre-existing mental health symptoms, IU and perceived COVID-19 threat may foster vulnerability to mental health problems during the pandemic, more so than objective threat levels.

Use of the Creating Opportunities for Parent Empowerment Program to Decrease Mental Health Problems in Ugandan Children Surviving Severe Malaria: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Paul Bangirana ◽  
Annet Birabwa ◽  
Mary Nyakato ◽  
Ann J. Nakitende ◽  
Maria Kroupina ◽  
...  
Keyword(s):  
Mental Health ◽  
Severe Malaria ◽  
Behavioral Problems ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Control Groups ◽  
Caregiver Depression ◽  
Randomized Controlled

Abstract Background: Severe malaria is associated with long-term mental health problems in Ugandan children. This study investigated the effect of a behavioral intervention for caregivers of children admitted with severe malaria, on the children’s mental health outcomes six months after discharge.Methods: This randomized controlled trial was conducted at Naguru Hospital in Kampala, Uganda from January 2018 to July 2019. Caregiver and child dyads were randomly assigned to either a psychoeducation arm providing information about hospital procedures during admission (control group) or a behavioral arm providing information about the child’s possible emotions and behavior during and after admission and providing age appropriate games for the caregiver and child (intervention group). Pre- and post-intervention assessments for caregiver anxiety and depression (Hopkins Symptom Checklist) and child mental health problems (Strength and Difficulties Questionnaire and the Child Behavioral Checklist) were done during admission and six months after discharge respectively. T-tests, analysis of covariance and Chi-Square were used to compare outcomes between the two treatment arms.Results: There were 120 caregiver-child dyads recruited at baseline with children aged 1.45 years to 4.89 years (mean age 2.85 years, SD = 1.01). The intervention and control groups had similar sociodemographic, clinical and behavioral characteristics at baseline. Caregiver depression at baseline, mother’s education and female sex of the child were associated with behavioral problems in the child at baseline (p<0.05). At six months follow-up, there was no difference in the frequency of behavioral problems between the groups (6.8% vs 10% in intervention vs. control groups, respectively, p = 0.72). Caregiver depression and anxiety scores between the treatment arms did not differ at six months follow-up. Conclusion: This behavioral intervention for caregivers and their children admitted with severe malaria had no effect on the child’s mental health outcomes at six months. Further studies need to develop interventions for mental health problems after severe malaria in children with longer follow-up time.ClinicalTrials.gov Identifier: NCT03432039

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

scholarly journals Protocol for an app-based affective control training for adolescents: proof-of-principle double-blind randomized controlled trial

2019 ◽  
Vol 4 ◽  
pp. 91
Author(s):  
Susanne Schweizer ◽  
Jovita T. Leung ◽  
Rogier Kievit ◽  
Maarten Speekenbrink ◽  
William Trender ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Matching Task ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Impact ◽  
Proof Of Principle

Background: 75% of all mental health problems have their onset before the end of adolescence. Therefore, adolescence may be a particularly sensitive time period for preventing mental health problems. Affective control, the capacity to engage with goal relevant and inhibit distracting information in affective contexts, has been proposed as a potential target for prevention. In this study, we will explore the impact of improving adolescents’ affective control capacity on their mental health. Methods: The proof-of-principle double-blind randomized controlled trial will compare the effectiveness of an app-based affective control training (AC-Training) to a placebo training (P-Training) app. In total, 200 (~50% females) adolescents (11-19 years) will train for 14 days on their training app. The AC-Training will include three different n-back tasks: visuospatial, auditory and dual (i.e., including both modalities). These tasks require participants to flexibly engage and disengage with affective and neutral stimuli (i.e., faces and words). The P-Training will present participants with a perceptual matching task. The three versions of the P-Training tasks vary in the stimuli included (i.e., shapes, words and faces). The two training groups will be compared on gains in affective control, mental health, emotion regulation and self-regulation, immediately after training, one month and one year after training. Discussion: If, as predicted, the proposed study finds that AC-Training successfully improves affective control in adolescents, there would be significant potential benefits to adolescent mental health. As a free app, the training would also be scalable and easy to disseminate across a wide range of settings. Trial registration: The trial was registered on December 10th 2018 with the International Standard Randomised Controlled Trial Number (Registration number: ISRCTN17213032).

scholarly journals Protocol for an app-based affective control training for adolescents: proof-of-principle double-blind randomized controlled trial

2019 ◽  
Vol 4 ◽  
pp. 91 ◽  
Author(s):  
Susanne Schweizer ◽  
Jovita T. Leung ◽  
Rogier Kievit ◽  
Maarten Speekenbrink ◽  
William Trender ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Matching Task ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Impact ◽  
Proof Of Principle

Background: 75% of all mental health problems have their onset before the end of adolescence. Therefore, adolescence may be a particularly sensitive time period for preventing mental health problems. Affective control, the capacity to engage with goal relevant and inhibit distracting information in affective contexts, has been proposed as a potential target for prevention. In this study, we will explore the impact of improving adolescents’ affective control capacity on their mental health. Methods: The proof-of-principle double-blind randomized controlled trial will compare the effectiveness of an app-based affective control training (AffeCT) to a placebo training (P-Training) app. In total, 200 (~50% females) adolescents (11-19 years) will train for 14 days on their training app. The AffeCT will include three different n-back tasks: visuospatial, auditory and dual (i.e., including both modalities). These tasks require participants to flexibly engage and disengage with affective and neutral stimuli (i.e., faces and words). The P-Training will present participants with a perceptual matching task. The three versions of the P-Training tasks vary in the stimuli included (i.e., shapes, words and faces). The two training groups will be compared on gains in affective control, mental health, emotion regulation and self-regulation, immediately after training, one month and one year after training. Discussion: If, as predicted, the proposed study finds that AffeCT successfully improves affective control in adolescents, there would be significant potential benefits to adolescent mental health. As a free app, the training would also be scalable and easy to disseminate across a wide range of settings. Trial registration: The trial was registered on December 10th 2018 with the International Standard Randomised Controlled Trial Number (Registration number: ISRCTN17213032).

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