Universally Delivered Interventions for Young People
ConditionDistress, Emotional
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-15
SponsorPakistan Institute of Living and Learning
About this trial
Mental health problems are amongst the major contributors to disease burden globally.
According to a recent study, 34% of young people worldwide (aged 10-19) suffer from depression and more than half of this population belongs to Southeast Asia such as Pakistan, India, and China.
Existing evidence shows that the access to mental health services in LMICs is limited and even fewer child psychiatric services are available.
One approach to overcome barriers such as limited availability of trained mental health professionals and risk of stigma may involve the use of simple, brief, scalable interventions based on basic psychological principles rather than treatment of psychopathology.
This study adapts and evaluates two brief interventions called behavioral activation single session intervention (BA-SSI) and 4-session Mindset intervention (MI) for teenage depression and anxiety in Pakistan, where access to mental health care is constrained by societal stigma and a shortage of clinicians.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Youth is between the age 12-15 years (inclusive) at the time of study enrollment.
Youth has one parent or legal guardian to give consent.
Youth speaks Urdu well enough to complete the paper based intervention.
Disqualifiers
Intellectual disability, as this may undermine comprehension of intervention material.
Adolescent with history of hospitalization or those who received inpatient treatment for a mental health problem within the past two months as the intervention being tested and this study is not designed for adolescent with acute medical and/or psychiatric treatment needs (if identified with any acute medical and/or psychiatric problem, they would be referred to appropriate health services through parents).
the school authority agrees to participate;
the schools shall be non-specialist public schools;
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral Activation - single session intervention (BA-SSI)
BehavioralSingle session intervention
4-session Mindset intervention
BehavioralThis is comprised of 4 sessions.
Treatment groups
564 Participants
are divided into 3 treatment groupsGroup A: Behavioral Activation - single session intervention (BA-SSI)Experimental treatment 1 intervention
Group B: 4-session Mindset interventionActive comparator 1 intervention
Group C: Waiting list control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility of recruitment
This will be monitored through a research trial log. This log will include information about number of schools approached, number of schools eligible to participate, number of schools consented to participate, number of YP approached, number of eligible YP and number of those who consented to participate
Time frame
Total recruitment period is 3 months. Change in numbers will be recorded from first month of recruitment to 3rd month of recruitment2
Feasibility of intervention
Session attendance for each participant in active study arms for each session will be recorded and maintained in participant intervention log.
Time frame
Retention of participants in the Intervention at the completion of one month intervention period.3
Depression
The Patient Health Questionnaire -8 will be used to assess the symptoms of depression. PHQ-8 scores are highly correlated with PHQ-9 scores, and the same cutoffs can be used to assess depression severity
Time frame
Change in scores from baseline to 3-month follow up.Secondary outcomes
1
The Revised Child Anxiety and Depression Scale
It is a 47-item, youth self-report questionnaire with subscales including: separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Items are rated on a 4-point Likert-scale from 0 ("never") to 3 ("always").
Time frame
Change in scores from baseline to 3-month follow up2
Growth Mindset scale
The mindset scale is comprised of 3 items regarding participants' views about the mindset such as intelligence, personality etc. There is not cutoff score. Higher total summed scores indicate stronger fixed mindsets, and lower scores, stronger growth mindsets.
Time frame
Change in scores from baseline to 3-month follow up3
Beck's hopelessness Scale short version
A 4-item short version of the Hopelessness Scale includes all the affective, cognitive and motivational components of hopelessness.
Time frame
Change in scores from baseline to 3-month follow up4
EuroQol Quality of Life scale
This scale provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. higher score indicare greater disability. there is no cutoff score.
Time frame
Change in scores from baseline to 3-month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pakistan Institute of Living and Learning
Lead sponsor
Fatima Jinnah Women University
Collaborator
Source ClinicalTrials.gov
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