Optimising outcomes for families with children with a Fetal Alcohol Spectrum Disorder diagnosis or 'At Risk' designation: A mixed-methods randomised trial of Parents under Pressure and the Alert® Program

Not Applicable

• Conditions: Fetal Alcohol Spectrum Disorder; Prenatal Alcohol Exposure; Mental Health - Other mental health disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12623000196640
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-23
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Children who have been assessed and received either a diagnosis of FASD with or without 3 sentinel facial features or an 'At Risk' designation within 18-months prior to referral will be eligible for the trial. This will be based on the Australian Guide to FASD.

Children must be enrolled in preparatory to Grade 3 at school and/or must reach age 5 years by June 30 of enrolling year through to maximum age 8.5 years. Children may be residing with a biological parent, kinship carer, foster carer, or carer designated by a governmental authority (e.g., Child Safety). Families must reside within 80 kilometres of Griffith University Logan campus to be eligible for recruitment. If literacy is an issue, measures and forms can be read to potential participants.

At least one caregiver per child is required to participate. Caregiver(s) must be aged 18 years and over, with no limits on the upper age range. Caregivers may be biological parents, kinship carers, foster carers, adoptive parents, or any other caregiver designated by governmental entities (e.g., Child Protection authorities).

Exclusion Criteria

Children and/or caregivers will be ineligible for the trial if: (1) Either the child or participating caregiver have been diagnosed with Intellectual Disability as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5 or DSM-5-TR) or ICD-10/11 (Severe or Profound) will be ineligible for the trial; (2) Either the child or participating caregiver has insufficient fluency in English for conversational use; or (3) Either the child or family have previously participated in the Parents under Pressure or Alert® program or are currently receiving either of these interventions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified