Systemic Autism-related Family Enabling (SAFE) study

A multi-centred, randomised, controlled feasibility study comparing the SAFE intervention with support as usual for families of children with autism spectrum disorder. Systemic Autism-related Family Enabling (SAFE) study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83964946

Enrollment

Registered

2017-11-20

Start date

2018-01-01

Completion date

Unknown

Last updated

2021-01-25

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

Conditions

Specialty: Mental health, Primary sub-specialty: Developmental disorders - Autism

Interventions

The SAFE intervention is an intensive programme of systemic family therapy designed to treat Autism Spectrum Disorder (ASD) and mental health related difficulties encountered by families of children w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Family includes child with ASD, aged 3-16 years 2. Diagnosis of ASD, severity level 1 or 2 3. Diagnosed within 12 months of consenting to the study 4. If other diagnoses are present, ASD must be primary diagnosis 5. Family are willing to comply with study requirements

Exclusion criteria

Exclusion criteria: 1. Children with ASD severity level 3 2. Children with ASD and intellectual impairment 3. Serious concomitant illness in child or family, or other circumstances such that they are unable to comply with study requirements 4. Families who may be a risk to safety of research staff 5. Insufficient English language, or capacity for parent/child to consent/assent to the study

Design outcomes

Primary

Measure	Time frame
Global family function is measured using the SCORE 15 questionnaire at baseline and 32 week follow up.	—

Secondary

Measure	Time frame
1. Child behaviour is measured using the Child Behaviour Checklist (CBCL) questionnaire at baseline and 32 week follow up 2. Child-parent attachment is measured using the Coding of Attachment-Related Parenting for use with children with Autism (CARP-A) assessment at baseline and 32 week follow up 3. Anxiety & depression is measured using the Patient Health Questionnaire (PHQ-SADS) at baseline and 32 week follow up 4. Reflective Functioning is measured using the reflective functioning questionnaire (RFQ) at baseline and 32 week follow up 5. Caregiving Helplessness is measured using the Caregiving Helplessness Questionnaire (CGHQ) at baseline and32 week follow up 6. Economic outcomes (EQ-5D-5L, CHU-9D, and resource use questionnaires) are measured at baseline and 32 week follow up	—

Measure

Time frame

1. Child behaviour is measured using the Child Behaviour Checklist (CBCL) questionnaire at baseline and 32 week follow up 2. Child-parent attachment is measured using the Coding of Attachment-Related Parenting for use with children with Autism (CARP-A) assessment at baseline and 32 week follow up 3. Anxiety & depression is measured using the Patient Health Questionnaire (PHQ-SADS) at baseline and 32 week follow up 4. Reflective Functioning is measured using the reflective functioning questionnaire (RFQ) at baseline and 32 week follow up 5. Caregiving Helplessness is measured using the Caregiving Helplessness Questionnaire (CGHQ) at baseline and32 week follow up 6. Economic outcomes (EQ-5D-5L, CHU-9D, and resource use questionnaires) are measured at baseline and 32 week follow up

—

Countries

United Kingdom

Contacts

Public ContactSarah Campbell

Outcome results

None listed

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