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Table 2 Participant timeline (SPIRIT figure): schedule of enrolment, interventions and assessments

From: The Early Positive Approaches to Support (E-PAtS) study: study protocol for a feasibility cluster randomised controlled trial of a group programme (E-PAtS) for family caregivers of young children with intellectual disability

   

Study period

 

Target of outcome (F = family caregiver, C = child)

Screening

Baseline

Randomisation

Follow-up

Timepoint

  

Up to 8 weeks prior to randomisation

Up to 5 weeks prior to intervention

3 months post-randomisation

3–9 months post-randomisation

12 months post-randomisation

Enrolment:

       

 Consent for eligibility

F

X

     

 Eligibility screen

F

X

     

 Vineland Adaptive Behaviour Scales (VABS) (3rd) [18]. FULL

C

X

     

 Brief Family Distress Scale

F

X

     

 Informed consent

F

 

X

    

 Contacts data

F

      

 Randomisation allocation

N/A

  

X

   

Assessments:

       

 Demographic data

F

      

 Warwick-Edinburgh Mental Well-Being Scale [23]

F

 

X

 

X

 

X

 Hospital Anxiety and Depression scale [24]

F

 

X

 

X

 

X

 EQ-5D-5L [25]

F

 

X

 

X

 

X

 Brief COPE [26]

F

 

X

 

X

 

X

 Child Behaviour Checklist (CBCL) [27]

C

 

X

 

X

 

X

 Paediatric Quality of Life InventoryTM Version 4.0 Generic Core Scales [28]

C

 

X

 

X

 

X

 Happiness of relationship scale [29]

F

 

X

 

X

 

X

 Family APGAR scale [30]

F

 

X

 

X

 

X

 Strengths and Difficulties Questionnaire [31]

F

 

X

 

X

 

X

 Sibling Relationship Questionnaire (revised) (where relevant) [32]

C

 

X

 

X

 

X

 Family Support Scale [33]

F

 

X

 

X

 

X

 Five Minute Speech Sample [34]

F and C

 

X

 

X

 

X

 Parenting Sense of Competence Scale (7 items) [35]

F

 

X

 

X

 

X

 Positive Gains Scale [36]

F

 

X

 

X

 

X

 Disagreement over issues related to child [29], co-parenting [37]

F

 

X

 

X

 

X

 Child-parent relationship scale [38]

F and C

 

X

 

X

 

X

 Parent activities/involvement index

F and C

 

X

 

X

 

X

 Group Cohesion Scale (8 items) [39]

F

   

X

  

 Client Service Receipt Inventory [40]

F & C

 

X

 

X

 

X

 Vineland Adaptive Behaviour Scales (VABS) (3rd) [18]. Brief.

C

     

X

 Participant views on use of routine collected data in future trial

F

     

X

 Process evaluation-participant interviews

F

    

X

 

 Process evaluation—facilitator interviews

N/A

    

X

 

 Process evaluation—service provider organisation interviews

N/A

    

X

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