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Parent-Child RelationsNCT04904861

Group Videoconferencing Intervention to Improve Maternal Sensitivity

A study testing Videoconference intervention group in people with Parent-Child Relations and Parenting, run by Pontificia Universidad Catolica de Chile at 2 sites in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Early childhood development is highly dependent on the sensitive care provided by their caregivers . Interventions focused on supporting parents to improve their sensitivity have been shown to be effective . Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Parent-Child Relations, Parenting
What is being tested?
Videoconference intervention group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesChile
Study dates
30 Jul 2021to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mother of a baby between 4 months and a year
  • Attended at one of the participating primary care health centers
  • Older than 18 years-old
  • Handling Spanish fluently
  • Have an electronic device that allows videoconferencing (computer, tablet or smart cell phone)

Who cannot join

  • Mother with severe intellectual deficit or psychotic symptoms
  • Participate in another early intervention at the health care center

Trial locations and contacts

2 sites in 1 country.

Chile2 sites

  • CESFAM Juan Pablo Segundo ANCORA UC Christus

    Santiago, 7610682

  • CESFAM Madre Teresa Calcuta ANCORA UC Christus

    Santiago, 7610682

Other trials in Chile

About this study

Official title: Group Videoconferencing Intervention to Improve Maternal Sensitivity in Mother-infant Dyads in Primary Care in Chile : Randomized Controlled Feasibility Trial

Background: Early childhood development is highly dependent on the sensitive care provided by their caregivers . Interventions focused on supporting parents to improve their sensitivity have been shown to be effective . The COVID-19 pandemic has had a great impact on mental health , with pregnant women and mothers of children under one year of age being an especially vulnerable group . On the other hand, access to mental health interventions in person is restricted by confinement measures , especially group interventions, so it is relevant to have remote interventions that support this group of mothers.

Objectives: to evaluate the feasibility and acceptability of a group videoconferencing intervention to improve maternal sensitivity aimed at mother / infant dyads attended in Primary Health Care in Chile Methodology: a randomized pilot feasibility study will be carried out with a mixed design with quantitative and qualitative evaluations. A face-to-face group intervention with proven effectiveness will be adapted to videoconferencing format , then 50 dyads will be randomized in a 3: 2 ratio to receive the videoconferencing intervention ( n=30) or the delivery of educational brochures (n=20) . The feasibility and acceptability will be evaluated assessing the participation, adherence and satisfaction in a quantitative way, in addition the qualitative evaluation will be carried out through interviews and focus groups. Changes in clinical outcomes will also be evaluated: maternal sensitivity, depressive symptoms, postnatal maternal attachment and infant socio-emotional development. This pilot study will allow the identification of the key parameters for the implementation and evaluation of the intervention, which will allow the design of an effectiveness study in the future.

Being tested
Videoconference intervention group, Control group
Keywords
maternal sensitivity, videoconferencing, group intervention, primary care, telehealth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Videoconference intervention groupBehavioural

    A short face-to-face dyadic group workshop focused on increasing maternal sensitivity was adapted to be carried out virtually by videoconference. The intervention considers 4 sessions, with a weekly frequency, with a minimum of 3 and a maximum of 6 dyads per group led by a monitor (psychologist). The activities are protocolized in a manual and are designed to be carried out by the mother with the baby under one year of age. .

  • Control groupOther

    Psycho-educational intervention : They will receive brochures with information on parenting (once a week for 4 weeks) in addition to the usual care in their primary care center

Study groups in NCT04904861
Study groupRoleWhat they receive
Videoconference Intervention groupExperimentalBrief group videoconferencing attachment-based intervention (sessions once a week for 4 weeks)
Receives: Behavioral: Videoconference intervention group
Control groupActive comparatorPsycho-educational intervention : They will receive brochures with information on parenting (once a week for 4 weeks)
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the intervention: eligibility rates

    percentage of eligible population that is recruitable: meets inclusion and not exclusion criteria

    Measured: Through study completion, approximately 18 months

  2. Feasibility of the intervention: attrition rates

    Attrition and follow-up rates by treatment condition.

    Measured: Through study completion, approximately 18 months

  3. Feasibility of the intervention: recruitment rates

    percentage that meets entry criteria and agrees to participate

    Measured: Through study completion, approximately 18 months

  4. Acceptability of the intervention : participation rates

    Proportion of performed sessions versus planned sessions.

    Measured: Through study completion, approximately 18 months

  5. Acceptability of the intervention : Satisfaction with the intervention

    Credibility/Expectancy Questionnaire (CEQ).Scores range from 0 to 100 with higher scores indicating higher acceptability of the intervention.

    Measured: Through study completion, approximately 18 months

  6. Acceptability of the intervention (qualitative assessment)

    Semi-structured interviews with monitors of the intervention (two psychologists) and focus groups with participating mothers (7 in total) with the aim of collecting information about the experience and identifying possible improvements

    Measured: Through study completion, approximately 18 months

Secondary outcomes (4)

  1. Change in Maternal sensitivity

    Adult Sensitivity Scale (E.S.A.) rubric with 19 indicators, each indicator is scored between 1 and 3, and a higher score indicates higher sensitivity

    Measured: Through study completion, approximately 18 months

  2. Change in Maternal Depressive Symptoms

    Edinburgh Postnatal Depression Scale (EPDS). Scores range from 0 to 30, with higher scores meaning higher depressive symptomatology.

    Measured: Through study completion, approximately 18 months

  3. Change in Children Socio Emotional Development

    Ages and Stages Questionnaire (ASQ-SE). Scores range from 0 to 75 with higher scores meaning lower socio-emotional development

    Measured: Through study completion, approximately 18 months

  4. Change in postnatal maternal bonding

    Maternal postnatal attachment scale (MPAS) : is a 19-item, self-report measure have 19 items, ranging from 1 (low bonding) to 5 (high bonding),

    Measured: Evaluation at study entry (T0) and at the end of the intervention (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start30 Jul 2021
  3. Primary completion30 Dec 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04904861
Sponsor's protocol ID
INTERDISCIPLINA II20029
Status last verified
Dec 2022
First submitted
17 May 2021
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Davenport MH, Meyer S, Meah VL, Strynadka MC, Khurana R. Moms Are Not OK: COVID-19 and Maternal Mental Health. Front Glob Womens Health. 2020 Jun 19;1:1. doi: 10.3389/fgwh.2020.00001. eCollection 2020.

    PubMed 34816146

  • Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Baron E, Grantham-McGregor S; Lancet Early Childhood Development Series Steering Committee. Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 7;389(10064):77-90. doi: 10.1016/S0140-6736(16)31389-7. Epub 2016 Oct 4.

    PubMed 27717614

  • Britto PR, Lye SJ, Proulx K, Yousafzai AK, Matthews SG, Vaivada T, Perez-Escamilla R, Rao N, Ip P, Fernald LCH, MacMillan H, Hanson M, Wachs TD, Yao H, Yoshikawa H, Cerezo A, Leckman JF, Bhutta ZA; Early Childhood Development Interventions Review Group, for the Lancet Early Childhood Development Series Steering Committee. Nurturing care: promoting early childhood development. Lancet. 2017 Jan 7;389(10064):91-102. doi: 10.1016/S0140-6736(16)31390-3. Epub 2016 Oct 4.

    PubMed 27717615

  • Torales J, O'Higgins M, Castaldelli-Maia JM, Ventriglio A. The outbreak of COVID-19 coronavirus and its impact on global mental health. Int J Soc Psychiatry. 2020 Jun;66(4):317-320. doi: 10.1177/0020764020915212. Epub 2020 Mar 31.

    PubMed 32233719

  • Ohannessian R, Duong TA, Odone A. Global Telemedicine Implementation and Integration Within Health Systems to Fight the COVID-19 Pandemic: A Call to Action. JMIR Public Health Surveill. 2020 Apr 2;6(2):e18810. doi: 10.2196/18810.

    PubMed 32238336

  • Binda V, Olhaberry M, Castanon C, Abarca C, Caamano C. A Group Videoconferencing Intervention (C@nnected) to Improve Maternal Sensitivity: Protocol for a Randomized Feasibility Trial. JMIR Res Protoc. 2022 Aug 15;11(8):e35881. doi: 10.2196/35881.

    PubMed 35969451

Questions about this trial

What is this clinical trial studying?

A study testing Videoconference intervention group in people with Parent-Child Relations and Parenting, run by Pontificia Universidad Catolica de Chile at 2 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the intervention: eligibility rates (time frame: Through study completion, approximately 18 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04904861, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

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