Effectiveness of a Problem-solving Intervention for Common Adolescent Mental Health Problems in India

NCT03630471 | Completed DMC

• 1 other identifier: SANPRIDE_002
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)

Keywords

Adolescents

Outcome Measures

Primary Outcomes (2)

• Mental health symptoms

  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.

  6 weeks

• Idiographic problems

  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.

  6 weeks

Secondary Outcomes (9)

• Mental health symptoms

  12 weeks post-randomization

• Idiographic problems

  12 weeks post-randomization

• Impact of mental health problems

  12 weeks post-randomization

• Internalising symptoms

  12 weeks post-randomization

• Externalising symptoms

  12 weeks post-randomization

Study Arms (2)

Control

ACTIVE COMPARATOR

Enhanced usual care (problem-solving booklets only).

Behavioral: Enhanced usual care

Intervention

EXPERIMENTAL

PRIDE 'Step 1' problem-solving intervention.

Behavioral: PRIDE 'Step 1' problem-solving intervention

Interventions

PRIDE 'Step 1' problem-solving intervention BEHAVIORAL

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.

Intervention

Enhanced usual care BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sangath: lead
• Harvard Medical School (HMS and HSDM): collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Sangath

New Delhi, National Capital Territory of Delhi, 110016, India

Location

Related Publications (12)

• Goodman R, Ford T, Simmons H, Gatward R, Meltzer H. Using the Strengths and Difficulties Questionnaire (SDQ) to screen for child psychiatric disorders in a community sample. Br J Psychiatry. 2000 Dec;177:534-9. doi: 10.1192/bjp.177.6.534.

  PMID: 11102329 BACKGROUND

• Weisz JR, Chorpita BF, Frye A, Ng MY, Lau N, Bearman SK, Ugueto AM, Langer DA, Hoagwood KE; Research Network on Youth Mental Health. Youth Top Problems: using idiographic, consumer-guided assessment to identify treatment needs and to track change during psychotherapy. J Consult Clin Psychol. 2011 Jun;79(3):369-80. doi: 10.1037/a0023307.

  PMID: 21500888 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Lee EH. Review of the psychometric evidence of the perceived stress scale. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):121-7. doi: 10.1016/j.anr.2012.08.004. Epub 2012 Sep 18.

  PMID: 25031113 BACKGROUND

• Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15.

  PMID: 19228398 BACKGROUND

• Patalay P, Fitzsimons E. Correlates of Mental Illness and Wellbeing in Children: Are They the Same? Results From the UK Millennium Cohort Study. J Am Acad Child Adolesc Psychiatry. 2016 Sep;55(9):771-83. doi: 10.1016/j.jaac.2016.05.019. Epub 2016 Jun 28.

  PMID: 27566118 BACKGROUND

• Lazarus RS, Folkman S. Stress, appraisal, and coping. New York, Springer Pub. Co.; 1984.

  BACKGROUND

• 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

  BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

  PMID: 10245370 BACKGROUND

• Malik K, Michelson D, Doyle AM, Weiss HA, Greco G, Sahu R, E J J, Mathur S, Sudhir P, King M, Cuijpers P, Chorpita B, Fairburn CG, Patel V. Effectiveness and costs associated with a lay counselor-delivered, brief problem-solving mental health intervention for adolescents in urban, low-income schools in India: 12-month outcomes of a randomized controlled trial. PLoS Med. 2021 Sep 28;18(9):e1003778. doi: 10.1371/journal.pmed.1003778. eCollection 2021 Sep.

  PMID: 34582460 DERIVED

• Michelson D, Malik K, Parikh R, Weiss HA, Doyle AM, Bhat B, Sahu R, Chilhate B, Mathur S, Krishna M, Sharma R, Sudhir P, King M, Cuijpers P, Chorpita B, Fairburn CG, Patel V. Effectiveness of a brief lay counsellor-delivered, problem-solving intervention for adolescent mental health problems in urban, low-income schools in India: a randomised controlled trial. Lancet Child Adolesc Health. 2020 Aug;4(8):571-582. doi: 10.1016/S2352-4642(20)30173-5. Epub 2020 Jun 23.

  PMID: 32585185 DERIVED

• Parikh R, Michelson D, Malik K, Shinde S, Weiss HA, Hoogendoorn A, Ruwaard J, Krishna M, Sharma R, Bhat B, Sahu R, Mathur S, Sudhir P, King M, Cuijpers P, Chorpita BF, Fairburn CG, Patel V. 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 Sep 18;20(1):568. doi: 10.1186/s13063-019-3573-3.

  PMID: 31533783 DERIVED

MeSH Terms

Conditions

Depression; Psychotic Disorders; Personality Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Vikram Patel, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm, individually randomized controlled trial with equal allocation of participants between arms.

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 14, 2018
• Study Start: August 20, 2018
• Primary Completion: January 20, 2019
• Study Completion: February 28, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

IN (1)