NCT07468994

Brief Summary

This study evaluates the effectiveness of the MindUP mindfulness-based program in reducing depression, anxiety, and stress among orphan adolescents in Pakistan. Adolescents living in orphan care institutions often experience significant psychological distress due to early life adversity, loss of parental support, and institutional living conditions. A school-based quasi-experimental design was used to examine whether participation in the MindUP program improves mental health outcomes among orphan adolescents. Participants were adolescents residing in orphanages in Pakistan who were assigned to either an intervention group receiving the MindUP program or a comparison group receiving routine institutional activities. The MindUP intervention consisted of structured mindfulness and social-emotional learning sessions designed to enhance emotional regulation, attention, and psychological well-being. The program was delivered over several weeks by trained facilitators. Psychological outcomes including depression, anxiety, and stress were measured using standardized self-report scales before and after the intervention. The study aims to determine whether the MindUP program is effective in improving mental health among orphan adolescents in low-resource institutional settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 9, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

MindUPMindfulness InterventionOrphan AdolescentsMental HealthPakistanSchool based intervention

Outcome Measures

Primary Outcomes (1)

  • Change in Depression Symptoms (DASS-21 Depression Subscale)

    Depression symptoms were measured using the Depression subscale of the Depression Anxiety Stress Scales (DASS-21). Higher scores indicate greater levels of depressive symptoms. Changes from baseline to post-intervention were assessed to evaluate the effectiveness of the MindUP program.

    Baseline to Post-Intervention (15 weeks)

Secondary Outcomes (2)

  • Change in Stress Levels (DASS-21 Stress Subscale)

    Baseline to Post-Intervention (15 weeks)

  • Change in Anxiety Symptoms (DASS-21 Anxiety Subscale)

    Baseline to Post-Intervention (15 weeks)

Study Arms (2)

MindUP Intervention Group

EXPERIMENTAL

Participants in this group received the MindUP mindfulness-based intervention program designed to improve emotional regulation, attention, and psychological well-being. The program consisted of structured sessions focusing on mindfulness practices, social-emotional learning, and awareness exercises delivered over several weeks.

Behavioral: MindUP Program

Control Group

NO INTERVENTION

Participants in this group continued their routine institutional activities and did not receive the MindUP intervention during the study period. Psychological outcomes were assessed at the same time points as the intervention group.

Interventions

MindUP ProgramBEHAVIORAL

MindUP is a mindfulness-based social and emotional learning program that teaches participants skills related to mindful awareness, emotional regulation, attention, and stress management through structured exercises and activities.

MindUP Intervention Group

Eligibility Criteria

Age11 Years - 16 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male adolescents aged 11-16 years.
  • Residing in an orphan care institution.
  • Currently enrolled in school (grades 7-8).
  • Able to understand and participate in the MindUP program sessions.
  • Provided assent to participate and permission obtained from the institutional authorities/guardians.

You may not qualify if:

  • Adolescents currently receiving psychological or psychiatric treatment.
  • Adolescents with severe cognitive or developmental disorders that would interfere with participation in the intervention.
  • Adolescents who did not complete baseline assessments or were absent for most intervention sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aghosh Alkhidmat Foundation College Murree

Islamabad, Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Officials

  • Rubina Hanif, PhD

    Quaid-i-Azam University, Islamabad.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to two parallel groups: an intervention group receiving the MindUP mindfulness-based program and a comparison group receiving routine institutional activities. Outcomes were measured at baseline and post-intervention to assess changes in depression, anxiety, and stress.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Scholar, Department of Psychology

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 13, 2026

Study Start

June 8, 2024

Primary Completion

September 21, 2024

Study Completion

September 28, 2024

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations