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Trial record 9 of 238 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

Brief Summary:

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
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
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
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.

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 (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.





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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).



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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Eligibility Criteria

For adolescent participants:

  • Enrolled as a student in Grades 9-12
  • Aged 13-20 years
  • Experiencing elevated mental health symptoms, based on response in the borderline or abnormal range (>19 for boys and >20 for girls) on the self-reported Total Difficulties scale of the Strengths and Difficulties Questionnaire
  • Experiencing significant distress and/or functional impairment, based on response in the abnormal range (>2) on the self-reported Impact Supplement of the SDQ
  • Experiencing difficulties for >1 month, based on response to the self-reported Chronicity item of the Impact supplement of the SDQ
  • 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 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 treatment for mental health problems
  • Received PRIDE intervention in past six months during clinical case series study;
  • V) Not providing assent
  • Adolescent whose parents are not providing consent

For Parents:

  • 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


Contacts
Contact: Sachin Shinde, PhD +91 9552291256 discovery.sachin@gmail.com

Sponsors and Collaborators
Sangath
Harvard Medical School
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Vikram Patel, MRCPsych PhD Harvard Medical School

Publications:

Responsible Party: Vikram Patel, Professor, Harvard T.H. Chan School of Public Health, USA, 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: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vikram Patel, Sangath:
Adolescents

Additional relevant MeSH terms:
Substance-Related Disorders
Personality Disorders
Chemically-Induced Disorders
Mental Disorders