Parent Social Buffering and Dyadic Music Intervention to Decrease Distress in Infants and Young Children during Hematopoietic Stem Cell Transplant and their Parents

Investigating Music Interventions for Reducing Stress in Young Children Undergoing a Procedure to Replace Damaged Cells

S
Sheri Robb

Primary Investigator

Enrolling By Invitation
3 years or below
All
Phase N/A
11 participants needed
1 Location

Brief description of study

The goal of the proposed study is to adapt an existing music-based intervention (Active Music Engagement; AME) using the ORBIT model, for infants and young children (3 years of age and under) undergoing stem cell transplant and their parents. Previous studies suggest that AME produces positive psychosocial outcomes for children 3-8 years of age with cancer and their parents, including decreased distress and increased positive coping in children, and lower endorsement of traumatic stress symptoms for parents. Systematic adaptation is required to ensure the intervention is developmentally appropriate and feasible during stem cell transplant. Adaptation will be informed using data from a two phased study. The first phase will describe patterns of parent buffering behaviors (responsiveness, positive regard, animation, dyadic mutuality), parent distress (emotional distress; traumatic stress symptoms), and child distress (emotional distress) at 4 key timepoints guided by previous research. In the second phase, we will adapt AME to support parent buffering based on existing research, relevant theoretical constructs, and patterns identified in phase 1.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

Following consent, the PI will arrange a time for parents to complete baseline (T1) measures during a routine clinic visit, within 30 days of their scheduled HSCT admission. After admission, there will be four scheduled sessions (T2-T5) that will include a dyadic play observation (5 minutes) and collection of parent-report distress measures for self and IYC (~20 minutes). Timing for T2-T5 is based on critical timepoints identified in previous research.  We will video-record observational sessions for analysis and parent interviews (completed within 2 weeks of discharge).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cancer, Hematopoietic stem-cell transplantation, HSCT
  • Age: 3 years or below
  • Gender: All

Eligibility Criteria (All Aims):

IYC and parents are eligible if: 

(a) the IYC is < 3 years of age at the time of their scheduled HSCT (allogeneic or autologous); 

(b) one parent (or caregiver) who is > 18 years of age) can be present for study sessions; 

(c) parent is able to complete study measures in English.

This study investigates how music can help reduce stress in young children undergoing stem cell transplants and their parents. The purpose is to adapt a music-based intervention called Active Music Engagement (AME) for children under 3 years old and their parents. This adaptation aims to decrease distress and improve coping strategies. The study will be conducted in two phases: first, observing parent and child behaviors and distress levels, and second, adapting the music intervention based on these observations.

During the study, parents and children will participate in scheduled sessions that include observing play and completing questionnaires about stress. These sessions help researchers understand how music affects stress and coping. Parents will also have interviews and video recordings will be used to analyze interactions. This process will help ensure the intervention is suitable for young children and effective in reducing distress.

  • Who can participate: Infants and young children under 3 years old undergoing scheduled stem cell transplants and their parents can participate. One parent or caregiver over 18 must be present and able to complete study measures in English.
  • Study details: The study aims to adapt a music intervention to reduce stress during procedures to replace damaged cells. Participants will take part in sessions where they observe play and complete stress questionnaires. They will also have interviews and video recordings to analyze interactions.
Updated on 23 Sep 2025. Study ID: NURS-IIR-MUSIC, 25655
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only