Stage-Matched Psychosocial Intervention for Parent Caregivers of Children With Leukemia in Pakistan

NCT07563335 | Enrolling By Invitation DMC

• 2 other identifiers: 2026-StageMatched-01ZZUIRB2025-02
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop, implement, and evaluate a stage-matched psychosocial intervention to enhance the psychological adaptation of parent caregivers of children with leukemia in Pakistan. The intervention is based on the Transactional Family Adaptation Model and Double ABC-X Model of family stress. It will be tailored to meet the specific emotional and behavioral needs of caregivers at different stages of their child's treatment journey. The study consists of four stages: (1) needs assessment, (2) intervention design, (3) intervention refinement, and (4) a pilot randomized controlled trial. The intervention will be tested at two tertiary care hospitals in Pakistan, with an expected sample size of 88 parent caregivers. Outcomes will assess feasibility, acceptability, and preliminary efficacy in improving psychological adaptation, reducing distress, and enhancing coping skills among caregivers.

Conditions

Childhood Leukemia

Keywords

"Parent caregivers"; "Psychological Adaptation"; "Childhood leukemia"

Outcome Measures

Primary Outcomes (3)

• Psychological Adaptation

  The primary outcome measure will assess the psychological adaptation of parent caregivers of children with leukemia. It will be measured using validated scales such as the Psychological Adaptation Scale (PAS), which evaluates the caregiver's emotional response to their child's illness, their coping strategies, and overall psychological adjustment.The scale contains 20 items and 4 dimensions, namely coping ability, self-reliance, social ability and psychological growth. The scale uses the Likert 5-point scoring method, 1 represents strongly disagree and 5 represents strongly agree. The higher the score, the better the psychological adaptation of the caregiver.

  Baseline, Mid-Intervention (Week 6), Post-Intervention (Week 12)

• Distress

  The level of emotional distress (including depression, anxiety, and stress) will be assessed using the DASS-21 (Depression, Anxiety, Stress Scale). The scale will measure the severity of distress experienced by parent caregivers during the intervention period.This scale consists 21 items, with 7 items per for each of the three scales. For reporting the score of the three scales Depression ( Normal 0-9, Mild 5-6, Moderate 7-10, Sever 11-13 and Extremely severe 14+), Anxiety ( Normal 0-3, Mild 4-5, Moderate 6-7, Sever 8-9 and Extremely severe 10+) and Stress ( Normal 0-7, Mild 8-9, Moderate 10-12, Sever 13-16 and Extremely severe 17+).Higher scores on the DASS-21 indicate worse outcomes (i.e., higher levels of distress, including depression, anxiety, and stress).

  Baseline, Mid-Intervention (Week 6), Post-Intervention (Week 12)

• Caregiver Burden

  The Caregiver Burden Scale will be used to assess the burden felt by caregivers in terms of time, physical, emotional, and financial strain due to caregiving responsibilities.It contained 22 items assessing experience of burden. The total score is 88 and for reporting the scale is: No or minimal burden ( 0-20) , Mild to moderate burden (21-40), Moderate to severe burden ( 41-60) and severe burden (61-88). Higher scores on the Caregiver Burden Scale indicate worse outcomes (i.e., higher levels of burden or strain experienced by the caregiver).

  Baseline, Mid-Intervention (Week 6), Post-Intervention (Week 12)

Study Arms (2)

Stage-Matched Psychosocial Intervention

EXPERIMENTAL

Parent caregivers in this arm will receive the stage-matched psychosocial intervention in addition to routine medical care over 12 weeks.

Behavioral: Stage-Matched Psychosocial Intervention; Other: Routine Medical Care

Routine Medical Care

NO INTERVENTION

Parent caregivers in this arm will receive routine medical care only.

Interventions

Stage-Matched Psychosocial Intervention BEHAVIORAL

This is a culturally adapted, theory-informed psychosocial intervention aimed at improving psychological adaptation and reducing distress among parent caregivers of children with leukemia. The intervention is stage-matched to the caregiver's phase in the child's treatment process and will include psychoeducation, emotional validation, problem-solving skills, and dyadic communication support.

Stage-Matched Psychosocial Intervention

Routine Medical Care OTHER

This arm consists of standard medical care provided to caregivers of children diagnosed with leukemia, without any additional psychosocial support intervention. The aim is to compare the outcomes of the intervention group with those receiving routine care.

Stage-Matched Psychosocial Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent caregiver (biological parent, step-parent, or legal guardian) primarily responsible for the daily care of a child diagnosed with leukemia.
• Child is receiving care at one of the participating pediatric oncology study facilities in Pakistan.
• Caregiver is aged 18 years or older.
• Caregiver is able to provide written informed consent.
• Caregiver is willing to participate in the 12-week study and complete study assessments.
• Caregiver is able to communicate in Urdu or another language used for study procedures at the participating site.

You may not qualify if:

• Parent caregiver plans to relocate outside the study area during the study period.
• Parent caregiver is not the primary caregiver of the child with leukemia.
• Parent caregiver is unable to provide informed consent.
• Parent caregiver has a severe cognitive, psychiatric, or medical condition that would prevent participation in the intervention or completion of study assessments, as judged by the study team.
• Parent caregiver is currently participating in another structured psychosocial intervention study that could interfere with this trial.

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (1)

Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, 25100, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Scholar

Model Details: This is a two-arm pilot cluster-randomized parallel-assignment study. Two pediatric oncology facilities in Pakistan will be assigned to either the stage-matched psychosocial intervention plus routine medical care or routine medical care alone. Cluster randomization at the facility level is used to reduce contamination between participants within the same setting and to support consistent delivery of the intervention by trained staff. Parent caregivers will be assessed at baseline, mid-intervention, and post-intervention over a 12-week study period.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 4, 2026
• Study Start: June 10, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)