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Is the infant massage intervention “Shantala Babymassage Individueel” effective for vulnerable families in early life?

The effectiveness of the Infant Massage Intervention “Shantala Babymassage Individueel” for vulnerable families in early life

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16929184
Enrollment
300
Registered
2022-03-29
Start date
2021-08-01
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This is an evaluation study of an intervention used in Preventive Child Healthcare in the Netherlands to enhance sensitive parenting and to reduce stress in parents at risk of low sensitive parenting behavior. Not Applicable

Interventions

Current interventions as of 03/02/2023: The intervention Individual Shantala Infant Massage is offered as part of standard care by some Preventive Child Healthcare (PCH) organizations
families with low socio-economic status (SES), family systems under pressure, maternal stress and/or excessive infant crying. The intervention aims at enhancing sensitive parenting and reducing the st

Sponsors

TNO (Netherlands Organization for Applied Scientific Research)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Parents or primary caregivers of a baby with an age up to (about) 3 months at the time of enrollment. 2. Included via one of the participating Preventive Child Healthcare organizations/locations 3. Participating in Individual Shantala Infant Massage intervention, offered by the PCH organization (intervention group only)

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 03/02/2023: Unable to complete questionnaires in Dutch or English (alone or with help) Previous participant exclusion criteria: Unable to understand the Dutch language.

Design outcomes

Primary

MeasureTime frame
Time points: T0 = Age baby between six weeks and (about) three months. (Prior to the intervention for the intervention group) T1 = Approximately four weeks after T0. (After the intervention ends for the intervention group) T2 = age baby five months 1. Physiological maternal stress is measured via hair cortisol. Hair samples are collected at T2. 2. Experienced maternal stress is measured using the Perceived stress scale (PSS-10, Cohen 1983) and the Postpartum Specific Anxiety Scale-Real Short Form (PSAS-RSF, Davies et al., 2021) at T0, T1, and T2. 3. Maternal sensitivity / mother-infant interaction (responsiveness, feelings about newborn, and cry perception): is measured using the Non-responsiveness scale of the Maternal Responsiveness Scale (MRQ, Leerkes & Qu, 2017), the Mother to Infant Bonding Scale (MIBS, Taylor, 2005) and the Cry Perception scale (Lester et al. 1992) at T0, T1, and T2. 4. Growth of the baby: data on length and weight assessed at multiple timepoints from birth to six months as part of standard care, are retrieved from PCH files after T2. 5. Development of the baby: Van Wiechen study scores (Jacobusse et al., 2008) assessed as part of standard PCH care at multiple timepoints, from birth to six months, are retrieved from PCH files after T2.

Secondary

MeasureTime frame
Time points: T0 = Age baby between six weeks and (about) three months. (Prior to the intervention for the intervention group) T1 = Approximately four weeks after T0. (After the intervention ends for the intervention group) T2 = age baby five months 1. Parenting confidence of the parent is measured using the Karitane Parenting Confidence Scale KPCS (Crcnec et al., 2008) at T0, T1 and T2 2. Information on (parental concerns with regard to) crying, feeding, sleeping and related outcomes measured using Likert scales at T0, T1 and T2. 3. To evaluate the process of the intervention, data is collected in several ways: 3.1 An evaluation questionnaire is filled out by participants in the intervention group at T1 3.2 Semi-structured logbooks are completed by professionals after each intervention session 3.3 (Focus group) interviews with participants and professionals at the end of the study

Countries

Netherlands

Contacts

Public ContactDafna Windhorst
dafna.windhorst@tno.nl+316-29647252

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026