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Evaluating an early, novel online intervention ('Family Focus') with and without coaching for primary carers of children with developmental regression

A pragmatic parallel-group randomised controlled trial to evaluate the effectiveness of coaching with an online intervention, compared to the online intervention alone, for families of children who have experienced developmental regression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25513446
Enrollment
56
Registered
2025-05-20
Start date
2026-02-06
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Health and wellbeing of parents (or other primary carers) of children with developmental regression Mental and Behavioural Disorders

Interventions

There are two components being tested: 1. The Family Focus program (online intervention) 2. Coaching delivered via videoconferencing Parent participants will be randomly assigned to one of two groups

Sponsors

Monash University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Parents: 1. With children aged between 1-15 years with suspected or confirmed loss of skills in one or more developmental domains (language, cognitive, social-emotional, motor) within the 18 months before their first visit to the Developmental Regression clinic 2. Live in Victoria, Australia 3. Are comfortable in reading English at a Grade 7 level 4. Have access to an internet-enabled device 5. Have an active email account

Exclusion criteria

Exclusion criteria: Parents whose children have: 1. A history of skill loss that cannot be verified through developmental surveillance records, clinical assessments, or video or audio recordings 2. Developmental regression took place in the context of significant environmental adversity (e.g. maltreatment, domestic violence, housing instability) 3. A condition that requires urgent medical intervention and stabilisation

Design outcomes

Primary

MeasureTime frame
Parent stress, measured using the Stress subscale of the Depression Anxiety Stress Scales (DASS-21), at post-intervention and 6-month follow-up.

Secondary

MeasureTime frame
1. Parent anxiety and depressive symptoms, measured using the Depression and Anxiety subscales of the DASS-21, at post-intervention and 6-month follow-up 2. Family empowerment, measured using the Family Empowerment Scale, at post-intervention and 6-month follow-up 3. Family quality of life, measured using the Beach Center Family Quality of Life Scale, at post-intervention and 6-month follow-up 4. Parent engagement in health-promoting activities, measured using the Health Promoting Activity Scale, at post-intervention and 6-month follow-up 5. Child global health outcomes, measured using the Clinical Global Impression-Severity (CGI-S) and CGI-Improvement (CGI-I) scales, at post-intervention and 6-month follow-up 6. Program uptake and engagement will be examined using metrics including the number of modules/podcasts viewed, the number of tipsheet downloads, the number of goals identified and worked toward, and parental ratings of module usefulness and satisfaction at post-intervention 7. Coaching uptake and engagement will be examined using metrics including the number of coaching sessions completed, the percentage of coaching sessions elected by participants out of the maximum of 12, and parental ratings of coaching sessions at post-intervention.

Countries

Australia

Contacts

Public ContactWan;Monica Sim;Leo

;

wan.sim@monash.edu;monica.leo@monashhealth.org+61 3 857 23947;+61 3 857 23947

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026