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NCT Number: NCT04131179

Multicenter Study to Evaluate the Clinical and Cost Effectiveness of a Youth Culturally Adapted Therapy (YCMAP)

To evaluate the clinical and cost-effectiveness of a youth culturally adapted manual assisted therapy (YCMAP) in Pakistani Adolescents with a history of self-harm

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Key information

Conditions

Self Harm Behavior Behavioral Symptoms Self-Injurious Behavior

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karachi Site, Karachi, Sindh, Pakistan

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About this study

Globally suicide is the second leading cause of death in young people 15-29 years of age. A recent review indicated that the reported suicide rates in South Asia are high compared to the global average. These figures are likely to be an under estimate since suicide data from many Low and Middle Income Countries (LMICs) is lacking. There is little official data on suicide from Pakistan, where suicide and self-harm remains as criminal act and socially, religiously condemned. However, there is accumulating evidence that both self-harm and suicide rates have been increasing in Pakistan.

This is the first RCT of a psychological intervention for self-harm in children and young people in Pakistan. It follows from the work of "Multicentre RCT to evaluate the clinical and cost effectiveness of culturally adapted manual assisted psychological intervention"(CMAP) trial currently taking place in adults who have self-harmed in Pakistan, by evaluating whether a similar intervention, adapted for children and adolescents, could be clinically and cost effective.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients age 12-18 years presenting to the participating GPs, emergency departments or admitted after an episode of self-harm to the participating hospitals or self-referrals.
  • History of recent self-harm. Recent self-harm is defined as self-harm occurring within the last 3 months (from the initial identification of a potential participant).
  • Participants living within the catchment area of the participating practices and hospitals.
  • Not needing inpatient psychiatric treatment.

Exclusion criteria

  • Severe mental illness (such as Psychotic disorder) as Self-harm commonly co- occurs with other mental health difficulties.
  • Conditions limiting engagement with assessment or intervention, including developmental and communication disorders, intellectual disabilities and autistic spectrum disorders.
  • Temporary resident unlikely to be available for follow up.

Treatment and study plan

Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP)

Behavioral

Y-CMAP is a manual assisted brief psychological intervention based on the principles of Cognitive Behaviour Therapy (CBT), including 8-10 sessions delivered over three months.

This intervention includes evaluation of the self-harm attempt, psycho education, crisis skills, problem solving and simple cognitive techniques to manage emotions, negative thinking,relapse prevention strategies and training on anger management and assertiveness.

Other names: Psychosocial Intervention

Primary outcomes

  1. Suicide Attempt Self Injury Interview SASII

    Time frame: Change in scores from baseline to 12th months

    Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII). Higher number on repetition indicates worse outcome and vice versa

Secondary outcomes

  1. Beck Scale for Suicidal ideation (BSI)

    Time frame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.

    Suicidal ideation will be assessed with the Beck Scale for Suicide Ideation (BSS; Beck & Steer, 1991), a 19-item self-report questionnaire, measuring the intensity and frequency of suicidal thoughts within the past week. Minimum total score is 0 and maximum total score can be 38. Higher scores indicate worse outcome.

  2. Beck Hopelessness Scale

    Time frame: [Time Frame: Baseline,3rd,6th,9th and 12th months]

    This is a 20 items scale measuring hopelessness. Higher scores on the scale indicate greater severity of hopelessness. Minimum total score on this scale can be 0 and maximum total score can be 20, with higher levels of hopelessness indicated by higher scores on the scale.

  3. Psychological Distress Scale

    Time frame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.

    It's a 10 item scale measuring emotional states with a 5 level response scale. The maximum score is 50 indicating severe distress, and the minimum score is 10 indicating no distress.

  4. EuroQol-5 Dimensions (EQ5-D)

    Time frame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.

    A standardised instrument to measure health status and associated population utility weights. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression).

  5. Client Satisfaction Questionnaire (CSQ).

    Time frame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.

    The participants will rate their satisfaction with treatment by using the CSQ. The total score ranges from 8 to 32. Higher scores indicate higher level of satisfaction.

  6. Client Services Receipt Inventory CSRI

    Time frame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.

    We will collect information on the use of health services (including the informal sector such as faith healers/Imams)

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

  • University of Manchester

Registry information

Official study title

Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP) in Adolescents Pakistani Patients With a History of Self Harm

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Oct 18, 2019
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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