Dataset Information

Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study.

ABSTRACT:

Background

Treatment fidelity (TF) refers to methodological strategies used to monitor and enhance the reliability and validity of interventions. We evaluated TF in a pragmatic RCT of music therapy (MT) for premature infants and their parents.

Methods

Two hundred thirteen families from seven neonatal intensive care units (NICUs) were randomized to receive standard care, or standard care plus MT during hospitalization, and/or during a 6-month period post-discharge. Eleven music therapists delivered the intervention. Audio and video recordings from sessions representing approximately 10% of each therapists' participants were evaluated by two external raters and the corresponding therapist using TF questionnaires designed for the study (treatment delivery (TD)). Parents evaluated their experience with MT at the 6-month assessment with a corresponding questionnaire (treatment receipt (TR)). All items as well as composite scores (mean scores across items) were Likert scales from 0 (completely disagree) to 6 (completely agree). A threshold for satisfactory TF scores (≥4) was used in the additional analysis of dichotomized items.

Results

Internal consistency evaluated with Cronbach's alpha was good for all TF questionnaires (α ≥ 0.70), except the external rater NICU questionnaire where it was slightly lower (α 0.66). Interrater reliability measured by intraclass correlation coefficient (ICC) was moderate (NICU 0.43 (CI 0.27, 0.58), post-discharge 0.57 (CI 0.39, 0.73)). Gwet's AC for the dichotomized items varied between 0.32 (CI 0.10, 0.54) and 0.72 (CI 0.55, 0.89). Seventy-two NICU and 40 follow-up sessions with 39 participants were evaluated. Therapists' mean (SD) TD composite score was 4.88 (0.92) in the NICU phase and 4.95 (1.05) in the post-discharge phase. TR was evaluated by 138 parents. The mean (SD) score across intervention conditions was 5.66 (0.50).

Conclusions

TF questionnaires developed to assess MT in neonatal care showed good internal consistency and moderate interrater reliability. TF scores indicated that therapists across countries successfully implemented MT in accordance with the protocol. The high treatment receipt scores indicate that parents received the intervention as intended. Future research in this area should aim to improve the interrater reliability of TF measures by additional training of raters and improved operational definitions of items.

Trial registration

Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers - "LongSTEP".

Clinicaltrials

gov Identifier: NCT03564184. Registered on June 20, 2018.

SUBMITTER: Gaden TS

PROVIDER: S-EPMC9983212 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study.

Gaden Tora Söderström TS Gold Christian C Assmus Jörg J Kvestad Ingrid I Stordal Andreas Størksen AS Bieleninik Łucja Ł Ghetti Claire C

Trials 20230303 1

<h4>Background</h4>Treatment fidelity (TF) refers to methodological strategies used to monitor and enhance the reliability and validity of interventions. We evaluated TF in a pragmatic RCT of music therapy (MT) for premature infants and their parents.<h4>Methods</h4>Two hundred thirteen families from seven neonatal intensive care units (NICUs) were randomized to receive standard care, or standard care plus MT during hospitalization, and/or during a 6-month period post-discharge. Eleven music the ...[more]

PMID: 36869392

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Project description:BackgroundIn Neonatal Intensive Care Units (NICUs) premature infants are exposed to various acoustic, environmental and emotional stressors which have a negative impact on their development and the mental health of their parents. Family-centred music therapy bears the potential to positively influence these stressors. The few existing studies indicate that interactive live-improvised music therapy interventions both reduce parental stress factors and support preterm infants' development.MethodsThe present randomized controlled longitudinal study (RCT) with very low and extremely low birth weight infants (born <30+0 weeks of gestation) and their parents analyzed the influence of music therapy on both the physiological development of premature infants and parental stress factors. In addition, possible interrelations between infant development and parental stress were explored. 65 parent-infant-pairs were enrolled in the study. The treatment group received music therapy twice a week from the 21st day of life till discharge from hospital. The control group received treatment as usual.ResultsCompared to the control group, infants in the treatment group showed a 11.1 days shortening of caffeine therapy, 12.1 days shortening of nasogastric/ orogastric tube feed and 15.5 days shortening of hospitalization, on average. While these differences were not statistically significant, a factor-analytical compound measure of all three therapy durations was. From pre-to-post-intervention, parents showed a significant reduction in stress factors. However, there were no differences between control and treatment group. A regression analysis showed links between parental stress factors and physiological development of the infants.ConclusionThis pilot study suggests that a live-improvised interactive music therapy intervention for extremely and very preterm infants and their parents may have a beneficial effect on the therapy duration needed for premature infants before discharge from hospital is possible. The study identified components of the original physiological variables of the infants as appropriate endpoints and suggested a slight change in study design to capture possible effects of music therapy on infants' development as well. Further studies should assess both short-term and long-term effects on premature infants as well as on maternal and paternal health outcomes, to determine whether a family-centered music therapy, actually experienced as an added value to developmental care, should be part of routine care at the NICU.

Project description:ImportanceParent-infant bonding contributes to long-term infant health but may be disrupted by preterm birth.ObjectiveTo determine if parent-led, infant-directed singing, supported by a music therapist and initiated in the neonatal intensive care unit (NICU), improves parent-infant bonding at 6 and 12 months.Design, setting, and participantsThis randomized clinical trial was conducted in level III and IV NICUs in 5 countries between 2018 and 2022. Eligible participants were preterm infants (under 35 weeks' gestation) and their parents. Follow-up was conducted across 12 months (as part of the LongSTEP study) at home or in clinics. Final follow-up was conducted at 12 months' infant-corrected age. Data were analyzed from August 2022 to November 2022.InterventionParticipants randomized to music therapy (MT) plus standard care or standard care alone during NICU admission, or to MT plus standard care or standard care alone postdischarge, using computer-generated randomization (ratio 1:1, block sizes of 2 or 4 varying randomly), stratified by site (51 allocated to MT NICU, 53 to MT postdischarge, 52 to both, and 50 to neither). MT consisted of parent-led, infant-directed singing tailored to infant responses and supported by a music therapist 3 times per week throughout hospitalization or 7 sessions across 6 months' postdischarge.Main outcome and measurePrimary outcome was mother-infant bonding at 6 months' corrected age, measured by the Postpartum Bonding Questionnaire (PBQ), with follow-up at 12 months' corrected age, and analyzed intention-to-treat as group differences.ResultsOf 206 enrolled infants with 206 mothers (mean [SD] age, 33 [6] years) and 194 fathers (mean [SD] age, 36 [6] years) randomized at discharge, 196 (95.1%) completed assessments at 6 months and were analyzed. Estimated group effects for PBQ at 6 months' corrected age were 0.55 (95% CI, -2.20 to 3.30; P = .70) for MT in the NICU, 1.02 (95% CI, -1.72 to 3.76; P = .47) for MT postdischarge, and -0.20 (95% CI, -4.03 to 3.63; P = .92) for the interaction (12 months: MT in NICU, 0.17; 95% CI, -2.71 to 3.05; P = .91; MT postdischarge, 1.78; 95% CI, -1.13 to 4.70; P = .24; interaction, -1.68; 95% CI, -5.77 to 2.41; P = .42). There were no clinically important between-group differences for secondary variables.Conclusions and relevanceIn this randomized clinical trial, parent-led, infant-directed singing did not have clinically important effects on mother-infant bonding, but was safe and well-accepted.Trial registrationClinicalTrials.gov Identifier: NCT03564184.

Project description:BackgroundTreatment fidelity, defined as ensuring that the recipient receives the intended intervention, is a critical component for accurate estimation of treatment efficacy. Ensuring fidelity and protocol adherence in behavioral trials requires careful planning during the design phase and implementation during the trial. The Tinnitus Retraining Therapy Trial (TRTT) randomized individuals with severe tinnitus to tinnitus retraining therapy (TRT, comprised of tinnitus-specific educational counseling (TC) and sound therapy (ST) using conventional sound generators (SGs)); Partial TRT (TC and placebo SGs); or standard of care (SOC), using a patient-centered care approach. Study audiologists administered both types of counseling in the TRTT, creating a challenge for managing protocol adherence.MethodsWe developed methods to enhance treatment fidelity including training, competency assessment, scripts, visual aids, and fidelity monitoring. Protocol monitors identified critical topics and content to be addressed for each type of counseling session, prepared corresponding scripts, and developed training aids and treatment-specific checklists covering those topics. Study audiologists' competency assessment required submission and review by the protocol monitors of an audiotape of one TC and one SOC counseling session. Treatment-specific aids included scripts, a 3-D model of the ear, handouts, and for TC, an illustrated flip-chart with talking points that followed the scripted content. During the trial, audiologists completed treatment-specific checklists during each counseling session, indicating topics covered/discussed and submitted audiotapes of counseling sessions. Protocol monitors reviewed audiotapes using corresponding treatment-specific checklists. Results for individual checklist items were tabulated and proportions calculated.ResultsTwenty-five audiologists were certified for TC and/or SOC counseling and 24 completed at least one counseling session. Adherence to each of 33 critical items on the TC checklist as assessed by the protocol monitor ranged from 70 to 100% across 37 counseling sessions (median 97%), with no difference between adherence for TRT (median, 97%) and partial TRT (median, 100%). Adherence to each of 44 critical items on the SOC checklist across 30 SOC counseling sessions ranged from 42 to 100% (median, 87.5%).ConclusionThe TRTT used multiple methods to address treatment fidelity. The close adherence to each treatment type was critical for evaluating the efficacy of the study interventions in this randomized trial.Trial registrationclinicaltrials.gov NCT01177137 . Registered on 5 August 2010.

Project description:Preterm delivery is a stressful event for mothers, posing them at risk for post-traumatic stress reactions. This study examined the degree of depressive symptoms and post-traumatic stress in mothers of preterm infants born before 32 gestational weeks depending on whether the infant received music therapy in the neonatal intensive care unit (NICU) or not. We included 33 mothers of preterm infants enrolled in a previously described prospective randomized controlled trial, of whom 18 received music therapy (mean mothers' age 34.1 ± 4.6 years) and 15 did not (mean mothers' age 29.6 ± 4.2). The degree of depressive symptoms, anxiety and acute stress reactions of these mothers were measured by using the German version of the Center for Epidemiologic Studies Depression Scale (CES-D) and Impact of Events Scale-Revised (IES-R) one week after birth (T1) and at infants' hospital discharge (T2). 605 music therapy sessions with a mean duration of 24.2 ± 8.6 min (range 10 to 50 min) were conducted two times a week from the second week of life (T1) until discharge (T2) to the infants from the intervention group. The infants from the control group received standard medical care without music therapy. The mean total CES-D score decreased from T1 (mean 34.7, 95% Confidence Interval (CI) 31.1-38.1) until T2 in all mothers (mean 16.3, 95% CI 12.6-20.1). Mothers whose infants received music therapy showed stronger declines of depressive and stress symptoms (with music therapy: CES-D mean difference of total score 25.7, 95% CI 20.0-31.3, IES-R mean difference of total score 1.7, 95% CI 0.9-2.5, IES-R mean difference of subcategory hyperarousal 10.2, 95% CI 6.2-14.3; without music therapy: CES-D mean difference of total score 9.5, 95% CI 3.8-15.3, IES-R mean difference of total score 0.1, 95% CI -1.0-1.2, IES-R mean difference of subcategory hyperarousal 1.6, 95% CI -4.7-7.9). Effect sizes were strong for CES-D, IES-R, and the hyperarousal subcategory, moderate for intrusion, and low for avoidance. These findings show that mothers of preterm infants are highly susceptible to supportive non-medical interventions such as music therapy to reduce psychological symptoms and distress during their infants' NICU stay.

Dataset Information

Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study.

Background

Methods

Results

Conclusions

Trial registration

Clinicaltrials

Publications

Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study.

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