A parenting course to reduce behavioural difficulties and improve the quality of life for families of those diagnosed with fetal alcohol spectrum disorders

Parenting course for parents of children with fetal alcohol spectrum disorders (FASD) versus waitlist: a randomised controlled feasibility study of the SPECIFiC (Salford Parents and carers’ Education Course for Improvements in Fasd outcomes In Children) Programme

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14483801

Enrollment

120

Registered

2022-09-27

Start date

2022-10-01

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Stress reduction in families diagnosed with fetal alcohol spectrum disorder Mental and Behavioural Disorders

Interventions

Families will be randomised 1:1 into the intervention or control arm. The intervention arm is SPECIFIC, a seven-week course where families meet online each week for 2.5 hours per week. Families will b

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For the index child: 1. Aged 5 to 12 years old (school years 1 to 7) 2. Diagnosis in line with internationally agreed criteria for FASD 3. Diagnosed within the previous 3 years For parents: 1. Able to commit to the whole seven sessions 2. Willing to wait for intervention if required

Exclusion criteria

Exclusion criteria: For parents: 1. Ever previously undergone specialist parenting training for FASD 2. Presence of acute safeguarding issues or concerns

Design outcomes

Primary

Measure	Time frame
Primary outcomes for this feasibility study: 1. Percentage of eligible parents invited who agree to participate measured using Clinic Registers at -4 and 0 weeks 2. Percentage of those participating who complete the study measured using intervention register at 0, 8 and 16 weeks Primary efficacy outcome (proof-of-concept): 1. Parent stress measured using the Parenting Stress Index 4th edition Short Form (PSI-4-SF) at 0, 8 and 16 weeks	—

Measure

Time frame

Primary outcomes for this feasibility study: 1. Percentage of eligible parents invited who agree to participate measured using Clinic Registers at -4 and 0 weeks 2. Percentage of those participating who complete the study measured using intervention register at 0, 8 and 16 weeks Primary efficacy outcome (proof-of-concept): 1. Parent stress measured using the Parenting Stress Index 4th edition Short Form (PSI-4-SF) at 0, 8 and 16 weeks

—

Secondary

Measure	Time frame
1. Children's behavioural difficulties measured using SDQ Strengths and Difficulties Questionnaire at 0, 8 and 16 weeks 2. Children's behavioural difficulties measured using ECBI Eyberg Child Behaviour Inventor at 0, 8 and 16 weeks 3. Parents’ psychological wellbeing measured using CORE-OM The Clinical Outcomes in Routine Evaluation–Outcome Measure at 0, 8 and 16 weeks 4. Parenting self-efficacy measured using TOPSE Tool to measure Parenting Self-Efficacy at 0, 8 and 16 weeks 5. Parent's health-related quality of life measured using EQ-5D-5L Tool at 0, 8 and 16 weeks 6. Parent and Child health and social care service use measured using CSRI Client Service Receipt Inventory at 0, 8 and 16 weeks 7. Parent satisfaction ratings measured using the Session Evaluation Form at each session, i.e. at 1, 2, 3, 4, 5, 6 and 7 weeks 8. Parent knowledge measured using FASD Knowledge Questionnaire at 0, 8 and 16 weeks 8. Acceptability (qualitative) measured using qualitative interviews at 16 weeks (subsample)	—

Measure

Time frame

1. Children's behavioural difficulties measured using SDQ Strengths and Difficulties Questionnaire at 0, 8 and 16 weeks 2. Children's behavioural difficulties measured using ECBI Eyberg Child Behaviour Inventor at 0, 8 and 16 weeks 3. Parents’ psychological wellbeing measured using CORE-OM The Clinical Outcomes in Routine Evaluation–Outcome Measure at 0, 8 and 16 weeks 4. Parenting self-efficacy measured using TOPSE Tool to measure Parenting Self-Efficacy at 0, 8 and 16 weeks 5. Parent's health-related quality of life measured using EQ-5D-5L Tool at 0, 8 and 16 weeks 6. Parent and Child health and social care service use measured using CSRI Client Service Receipt Inventory at 0, 8 and 16 weeks 7. Parent satisfaction ratings measured using the Session Evaluation Form at each session, i.e. at 1, 2, 3, 4, 5, 6 and 7 weeks 8. Parent knowledge measured using FASD Knowledge Questionnaire at 0, 8 and 16 weeks 8. Acceptability (qualitative) measured using qualitative interviews at 16 weeks (subsample)

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 16, 2026