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Trial record 29 of 66 for:    strength | ( Map: India )

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
Sponsor:
Collaborators:
Harvard Medical School
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Sangath

Brief Summary:
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 difficulties and associated impact. Participants will receive either a brief problem-solving intervention delivered by lay counsellors (intervention), or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health difficulties 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 difficulties 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
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)
Masking Description:

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.

Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
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.

Experimental: Intervention
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.





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Idiographic problems [ Time Frame: 12 weeks post-randomization ]
    The adolescent-reported YTP severity score at 12 weeks will be a secondary outcome.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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).



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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility criteria:

For adolescent participants:

  • Enrolled as a student in Grades 9-12 (corresponding to 13-20 years of age)
  • Experiencing elevated mental health symptoms, based on response in the borderline or abnormal range (scores of 19 or higher for boys and 20 or higher for girls) on the self-reported SDQ Total Difficulties scale
  • Experiencing significant distress and/or functional impairment, based on response in the abnormal range (scores of 2 or higher) on the self-reported SDQ Impact Supplement
  • Experiencing difficulties for >1 month, based on response to the self-reported Chronicity item from the SDQ Impact Supplement
  • For adolescents under 18 years of age, able to provide informed assent to participate and supported by parental consent
  • For adolescents over 18 years of age, able to provide informed consent to participate

For parent participants:

  • A primary parental caregiver or guardian for the index adolescent
  • Able to provide informed consent to participate, and if adolescent age 18+ years, parental involvement is supported by the index adolescent
  • Proficient in spoken English or Hindi

Exclusion criteria:

For adolescent participants:

  • Requiring urgent medical attention (defined as needing emergency treatment or in-patient admission)
  • Unable to communicate clearly (due to a speech or hearing disability or inability to comprehend one of the program's languages)
  • Already receiving intervention for mental health problems
  • Received PRIDE intervention in past six months during pilot study
  • Not providing assent
  • Adolescent whose parents are not providing consent

For parent participants:

  • Unable to communicate clearly (due to a speech or hearing disability or inability to comprehend one of the program's languages)
  • Intoxicated at the point of consent or assessment

Information from the National Library of Medicine

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


Locations
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India
Sangath
New Delhi, Delhi, India, 110016
Sponsors and Collaborators
Sangath
Harvard Medical School
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Vikram Patel, PhD Harvard Medical School
  Study Documents (Full-Text)

Documents provided by Sangath:
Statistical Analysis Plan  [PDF] May 7, 2019


Publications:
Lazarus RS, Folkman S. Stress, appraisal, and coping. New York, Springer Pub. Co.; 1984.
Stewart-Brown S. The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS): Performance in Different Cultural and Geographical Groups. In: Keyes CLM, editor. Mental Well-Being: International Contributions to the Study of Positive Mental Health. Dordrecht: Springer Netherlands; 2013. p. 133-50

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sangath
ClinicalTrials.gov Identifier: NCT03630471     History of Changes
Other Study ID Numbers: SANPRIDE_002
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised Individual Participant Data along with data dictionaries will be shared with other researchers after 12 months of completion of the trial. Data pertaining to the interventions received and outcomes at primary and secondary end point will be shared upon reasonable requests made to the PI and in accordance with the guidelines of sponsors, collaborators and funder of the study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 12 months after completion of trial.
Access Criteria: Access to data will be granted to researchers after review of requests by PI and in accordance with the guidelines of sponsors, collaborators and funder of the study.
URL: http://datacompass.lshtm.ac.uk/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sangath:
Adolescents
Additional relevant MeSH terms:
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Substance-Related Disorders
Personality Disorders
Mental Disorders
Chemically-Induced Disorders