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Pilot randomized controlled trial of the “WHO Parent Skills Training Programme for Caregivers of a Child with a Developmental Disorder”: Italian trial

Pilot randomized controlled trial of the “WHO Parent Skills Training Programme for Caregivers of a Child with a Developmental Disorder”: Italian trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11702408
Enrollment
72
Registered
2022-11-01
Start date
2016-09-01
Completion date
Unknown
Last updated
2022-11-14

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

Following baseline ascertainment, participants, identified by sequentially assigned identification numbers, were randomly assigned by an independent statistician to either CST (n = 43) or eTAU (n = 43
2022. Licence: CC BY-NC-SA 3.0 IGO.] The 12-sessions CST intervention program includes 3 home visits and 9 group sessions training caregivers via adult-learning techniques (Salomone et
the third home visit delivers coaching and support for independent practice and occurs after the last group session. The group sessions cover the following topics: getting and keeping c

Sponsors

University of Turin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged between 24 and 59 months old and their parent(s)/guardian(s) or other caregivers 2. Recruited from Child Neuropsychiatry Services of the Italian National Health System 3. Clinical diagnosis of autism confirmed by research evaluation

Exclusion criteria

Exclusion criteria: For the parent: 1. Level of Italian speaking insufficient to fully participate in the intervention 2. Any record of a serious psychiatric disorder in the local clinical notes in the parent (such as to prevent the use of the intervention)

Design outcomes

Primary

MeasureTime frame
1. Child autism symptom severity measured using the Brief Observation of Social Communication Change (BOSCC) total score at baseline and 3 months post-intervention 2. Child joint engagement measured using the Child Joint Engagement item of the Joint Engagement Rating Inventory (JERI) at baseline and 3 months post-intervention 3. Child availability to interact measured using the Child Availability to Interact (three items: reversed scored unengaged, attention to the caregiver, initiation of communication) of the JERI at baseline and 3 months post-intervention 4. Flow of the interaction measured using the Fluency and connectedness item of the JERI at baseline and 3 months post-intervention 5. Parent skills supportive of interaction measured using the Parent Support of Interaction (three items: scaffolding, following in, effective communication) of the JERI at baseline and 3 months post-intervention

Secondary

MeasureTime frame
1. Child expressive vocabulary measured using the Total Expressive Words raw counts on the Italian version of the MacArthur-Bates Communicative Development Inventories (MCDI) at baseline and 3 months post-intervention 2. Child receptive vocabulary measured using the Total Receptive Words raw counts on the Italian version of the MCDI at baseline and 3 months post-intervention 3. Child gestures measured using the Total Gestures raw counts on the Italian version of the MCDI at baseline and 3 months post-intervention 4. Child adaptive behaviour measured using the Adaptive Behavior Composite of the Vineland II (VABS) age-normed Standard Scores at baseline and 3 months post-intervention 5. Parenting satisfaction and self-efficacy measured using the Total Score of the Parenting Sense of Competence Scale (PSOC) at baseline and 3 months post-intervention 6. Parenting self-efficacy specific to the child with neurodevelopmental disorder measured using the Caregiver Self-efficacy Questionnaire (CSQ) total score at baseline and 3 months post-intervention 7. Parental stress specific to autism measured using the Autism Parent Stress Index (APSI) total score at baseline and 3 months post-intervention

Countries

Italy

Outcome results

None listed

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