Effectiveness of a Problem-solving Intervention for Common Adolescent Mental Health Problems in India (PRIDE)
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|ClinicalTrials.gov Identifier: NCT03630471|
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : August 15, 2018
The objective of this study is to evaluate the effectiveness of a low-intensity, lay counsellor-delivered, problem-solving intervention for adolescents with common mental health problems attending Government-run secondary schools in New Delhi, India.
The primary hypothesis is that the PRIDE intervention will be superior to an Enhanced Usual Care (EUC) control condition in reducing the severity of participating adolescents' self-reported mental health symptoms and idiographic problems at six weeks post-randomization.
The secondary hypotheses are that the intervention will be superior to the control condition with respect to:
- reduced self-reported adolescent mental health symptoms and idiographic problems at 12 weeks post-randomization
- reduced parent-reported adolescent mental health symptoms at six and 12 weeks post-randomization
- reduced self- and parent-reported distress/functional impairment for adolescents at six and 12 weeks post-randomization
- reduced self-reported perceived stress for adolescents at six and 12 weeks post-randomization
- improved self-reported adolescent wellbeing at six and 12 weeks post-randomization
- improved remission rates derived from predetermined cut-offs for self-reported adolescent mental health symptoms and associated distress/functional impairment at six and 12 weeks post-randomization
A process evaluation will be nested in the trial to provide findings that will assist in the interpretation of the trial results and to inform potential implementation of the PRIDE intervention on a wider scale.
|Condition or disease||Intervention/treatment||Phase|
|Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)||Behavioral: PRIDE 'Step 1' problem-solving intervention Behavioral: Enhanced usual care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A two-arm, individually randomized controlled trial with equal allocation of participants between arms.|
|Masking:||Double (Investigator, Outcomes Assessor)|
The randomization list will be generated by an independent statistician. The randomization code will be concealed using sequentially numbered opaque sealed envelopes to maximize allocation concealment.
Baseline assessments will be carried out by field researchers prior to randomization. The six- and 12-week outcome assessments will be carried out by a team of field researchers who will be blind to allocation status.
|Official Title:||The Effectiveness of a Low-intensity, Lay Counsellor-delivered, Problem-solving Intervention for Common Mental Health Problems in School-going Adolescents in New Delhi, India: the PRIDE Study Protocol for a Randomized Controlled Trial|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||April 30, 2019|
Active Comparator: Enhanced usual care
Enhanced usual care (problem-solving booklets only).
Behavioral: Enhanced usual care
There is no established mental health service provision in the collaborating schools. The control arm participants will receive an enhancement of this 'usual care' (essentially, no care) by having access to the same illustrated booklets used in the Intervention arm, albeit without any counsellor contact.
PRIDE 'Step 1' problem-solving intervention.
Behavioral: PRIDE 'Step 1' problem-solving intervention
The PRIDE problem-solving intervention is one component of the PRIDE stepped care treatment architecture which comprises two sequential treatments of incremental intensity. 'Step 1' is a brief, first-line treatment. It is grounded in stress-coping theory, with a technical focus on practical problem-solving to modify developmentally salient stressors.
Step 1 has been designed as a 'low-intensity' intervention requiring fewer resources than conventional psychological treatments. This is achieved through a relatively brief delivery schedule (5 x 30-minute sessions spread over 3 weeks) and limited requirement for specialists. The delivery agents are lay counsellors receiving a combination of specialist and peer supervision. The counsellors offer guidance sessions to support the learning and implementation of problem-solving and complementary coping skills. Illustrated booklets are used to support learning of problem-solving concepts and skills practice at home.
- Change in Mental health symptoms [ Time Frame: Baseline, 6 weeks and 12-weeks post-randomization ]The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-report measure of youth mental health difficulties (Goodman et al., 2000). A Total Difficulties score is derived by summing items from four problem subscales (Emotional, Conduct, Hyperactivity/inattention, and Peer problems). The measure is the most widely used clinical and research instrument in the field of child and adolescent mental health globally. The Hindi version will be used in complementary forms for self-report by adolescents and parents. The adolescent-reported Total Difficulties score will be a co-primary outcome, while the parent-reported Total Difficulties score will be a secondary outcome.
- Change in Idiographic problems [ Time Frame: Baseline, 6 weeks and 12-weeks post-randomization ]The Youth Top Problems (YTP) is a brief, idiographic measure which identifies, prioritizes and scores respondents' three main problems (Weisz et al., 2011). Each nominated problem is scored from 0 ('not a problem') to 10 ('huge problem'). A mean severity score is calculated by summing individual problem scores and then dividing by the number of nominated problems. The YTP will be used in the current trial to assess problems that other scales might address generally or otherwise miss; identify specific priorities of the participant within a larger array of problems; and provide a sensitive method for tracking individual progress against prioritized 'top' problems.
- Impact of mental health difficulties [ Time Frame: Baseline, six and 12 weeks post-randomization ]The SDQ Impact Supplement measures distress and functional impairment associated with index mental health difficulties identified on the main SDQ scale.
- Perceived stress [ Time Frame: Baseline, six and 12 weeks post-randomization ]The Perceived Stress Scale-4-item version (PSS-4) will be used to measure the perception of stress, reflecting the degree to which situations are appraised as stressful during the preceding month (Cohen et al., 1983). This measure was chosen because of its relevance as a presumed mechanism of change within the problem-solving intervention, consistent with stress-coping theory (Lazarus & Folkman, 1984). It has been translated into Hindi and used in a number of surveys and as an outcome measure in trials around the world (Lee, 2012).
- Mental wellbeing [ Time Frame: Baseline, six and 12 weeks post-randomization ]The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) will be used to measure mental wellbeing (Stewart-Brown et al., 2009), which has been closely linked with social factors such as peer bullying and perception of school connectedness (Patalay & Fitzsimons; 2016). It may therefore be especially amenable to problem-solving around common life difficulties encountered by school-going adolescents. The SWEMWBS is widely used internationally, (Stewart-Brown, 2012) and a Hindi version is available.
- Remission [ Time Frame: Six and 12 weeks post-randomization ]This will be defined as falling below baseline eligibility cut-offs on both the SDQ Total Difficulties scale and Impact Supplement (i.e. Total Difficulties score in normal range and Impact score in the normal or borderline range).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630471
|Contact: Sachin Shinde, PhD||+91 firstname.lastname@example.org|
|Principal Investigator:||Vikram Patel, MRCPsych PhD||Harvard Medical School|