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An evaluation of the feasibility, acceptability, and effectiveness of Kica, a mobile application based on the WHO Caregiver Skills Training

Randomised controlled trial of Kica, a mobile application based on the WHO Caregiver Skills Training

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17143198
Enrollment
120
Registered
2024-11-12
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Autism spectrum disorder Mental and Behavioural Disorders

Interventions

The researchers are inviting participation from two pools of participants: caregivers who have previously received in-person CST (referred to as “experienced caregivers”) and caregivers who have not p
naïve parents, n = 30) on a 1:1 allocation ratio using stratified randomization by age (below 60 months and 60 months and above) and autism severity (ADOS-2 Comparative Severity Score: minimal/low and
Salomone et al., 2019). Kica-CST aims to support caregivers of children with Autism Spectrum Disorder in acquiring knowledge and strategies to promote caregiver-child interactions. It consists of six

Sponsors

University of Milano-Bicocca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged between 18 and 72 months old and their parent(s)/guardian(s) or other caregivers 2. Recruited from Child Neuropsychiatry Services of the Italian National Health System 3. Child local Clinical diagnosis of autism meeting the diagnostic cutoff on the ADOS-2

Exclusion criteria

Exclusion criteria: 1. Severe sensory disabilities (blindness, deafness) of the child, for whom intervention strategies are not adequate 2. Level of fluency in Italian language in parents insufficient to understand short written texts and audiovisual material

Design outcomes

Primary

MeasureTime frame
1. Parent skills supportive of interaction measured using the Caregiver items (three items: scaffolding, following in, caregiver’s affect) of the JERI at baseline and post-intervention 2. The amount of child communication acts that are initiations of communication during free-play caregiver/child interaction measured using the Child Initiations item of the Dyadic Communication Measure for Autism (DCMA) at baseline and post-intervention 3. Flow of the interaction measured using the Interaction Items (i.e., fluency and connectedness, shared routines and rituals) of the Joint Engagement Rating Inventory (JERI) at baseline and post-intervention

Secondary

MeasureTime frame
1. The use of parental strategies during free-play caregiver/child interaction measured using the WHO CST Adult-Child Interaction Fidelity Rating at baseline and post-intervention 2. The use of parental strategies during free-play caregiver/child interaction measured using the Naturalistic Developmental Behavioral Interventions-Fidelity (NDBI-Fi) at baseline and post-intervention 3. Parental interpretation of communicative signals measured using the Perceived Maternal Parenting Self-Efficacy (PMP S-E) at baseline and post-intervention 4. Parental self-efficacy measured using the Brief Parental Self-Efficacy Scale (BPSES) at baseline and post-intervention 5. Parental self-efficacy measured using the Me as a Parent Scale Short Form (MaaPs-SF) at baseline and post-intervention 6. Parental mental well-being measured using the Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) at baseline and post-intervention 7. Parental depression, anxiety and stress measured using the Depression Anxiety Stress Scales (DASS-21) at baseline and post-intervention 8. Parental knowledge of intervention strategies and skills to apply them in a naturalistic context measured using the Participant Knowledge and Skills Test at baseline and post-intervention 9. Child joint engagement measured using the Child’s Joint Engagement item of the Joint Engagement Rating Inventory (JERI) at baseline and post-intervention 10. Child availability to interact measured using the Child Availability to Interaction items (unengaged; object engagement; stereotyped, restricted, repetitive behavior; attention to caregiver; initiation of communication; expressive language level and use) of the JERI at baseline and post-intervention 11. Child gestures measured using the Total Gestures raw counts on the Italian version of the MacArthur-Bates Communicative Development Inventories (CDI) at baseline and post-intervention 12. Child expressive vocabulary measured using the Total Expressive Words raw counts on the

Countries

Italy

Contacts

Public ContactErica Salomone
erica.salomone@unimib.it+39 (0)2 6448 3816

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026