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 : Completed
First Posted : August 14, 2018
Last Update Posted : May 21, 2019
|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)|
|Actual Enrollment :||250 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|
|Actual Study Start Date :||August 20, 2018|
|Actual Primary Completion Date :||January 20, 2019|
|Actual Study Completion Date :||February 28, 2019|
Active Comparator: Control
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 (up to 5 x 20-30-minute sessions spread over approximately 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.
- Mental health symptoms [ Time Frame: 6 weeks ]The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-report measure of youth mental health symptoms (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 SDQ Total Difficulties score (at 6-week end-point) will be a co-primary outcome, while the corresponding caregiver-reported SDQ Total Difficulties score will be an exploratory outcome.
- Idiographic problems [ Time Frame: 6 weeks ]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 to assess problems that other scales might address generally or otherwise miss; while providing a sensitive measure of specific priorities of the participant within a larger array of problems.
- Mental health symptoms [ Time Frame: 12 weeks post-randomization ]The adolescent-reported SDQ Total Difficulties score at 12 weeks will be a secondary outcome, while the corresponding caregiver-reported SDQ Total Difficulties score will be an exploratory outcome.
- Idiographic problems [ Time Frame: 12 weeks post-randomization ]The adolescent-reported YTP severity score at 12 weeks will be a secondary outcome.
- Impact of mental health problems [ Time Frame: 12 weeks post-randomization ]The SDQ Impact Supplement measures distress and functional impairment associated with index mental health problems identified on the main SDQ scale. The adolescent-reported SDQ Impact Supplement score will be a secondary outcome, while the corresponding caregiver-reported SDQ Impact Supplement score will be an exploratory outcome.
- Internalising symptoms [ Time Frame: 12 weeks post-randomization ]Adolescent-reported internalising symptoms will be assessed as a secondary outcome using the combined peer and emotional problem sub-scales of the SDQ. The corresponding caregiver-reported SDQ Internalising score will be an exploratory outcome.
- Externalising symptoms [ Time Frame: 12 weeks post-randomization ]Adolescent-reported externalising symptoms will be assessed as a secondary outcome using the combined conduct and hyperactivity problem sub-scales of the SDQ. The corresponding caregiver-reported SDQ Externalising score will be an exploratory outcome.
- Prosocial behaviour [ Time Frame: 12 weeks post-randomization ]Adolescent-reported prosocial behaviour will be assessed as an exploratory outcome using the prosocial sub-scale of the SDQ.
- Perceived stress [ Time Frame: 12 weeks post-randomization ]The adolescent-reported Perceived Stress Scale-4-item version (PSS-4) will be used as a secondary outcome measure to assess 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: 12 weeks post-randomization ]The adolescent-reported Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) will be used as a secondary measure to assess 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, 2013) and a Hindi version is available.
- Clinical remission [ Time Frame: 12 weeks post-randomization ]This secondary outcome will be defined as falling below baseline eligibility cut-offs on both the SDQ Total Difficulties scale and Impact Supplement (i.e. SDQ 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
|New Delhi, Delhi, India, 110016|
|Principal Investigator:||Vikram Patel, PhD||Harvard Medical School|