Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001220853p
Ethics application status
Submitted, not yet approved
Date submitted
2/08/2021
Date registered
13/09/2021
Date last updated
13/09/2021
Date data sharing statement initially provided
13/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of engaging fathers and daughters on girls' participation in basketball: A preliminary evaluation of the 'Daughters and Dads basketball' program
Scientific title
Process evaluation of the 'Daughters and Dads basketball’ program: a sport-specific variant of the ‘Daughters and Dads Active and Empowered program’: an investigation of recruitment, fidelity, compliance, attendance and satisfaction for girls aged 7-12 years and their fathers
Secondary ID [1] 304302 0
n/a
Universal Trial Number (UTN)
n/a
Trial acronym
n/a
Linked study record
This record is a sub-study of RCT ACTRN12617001450303 and Trial Id: ACTRN12616001270404

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 322037 0
Sedentary behaviour 322038 0
Condition category
Condition code
Public Health 319768 319768 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fathers will attend one 90 minute Dads-only education session covering all key content which includes program rationale, the unique influence of fathers, engaging daughters in basketball and pinkification. For Dads-only, the education session focuses on proven parenting key topic areas to improve their daughters’ skill proficiency in basketball, basketball enjoyment and participation and social-emotional wellbeing.This will be delivered by trained facilitator using powerpoint which includes interactive activities, short videos, gifs, imagery and text.

One week later, Fathers and daughters will attend 8 x 90 minute weekly face-face sessions, with the total duration being 9 weeks.

* Each of the 8 weekly daughters and dads session will be broken up into 2 components:
(i) a 30-minute education session with fathers and daughters together
(ii) a 60-minute practical session where fathers and daughters participate together,

The daughters and dads’ education sessions focus on understanding the game of basketball, and developing girls’ basketball skills and key social and emotional skills including resilience, persistence, positivity and bravery. Content will be sport specific e.g., ‘Learning the Game of basketball – Part 1’, ‘Female Basketball Superstars'.

The practical sessions focus on 3 key areas - rough and tumble play and handles, basketball skill development, and modified basketball games

* The sessions will be group-based (~12 father/daughter dyads per program), delivered by university-trained facilitators (qualified teachers) at local schools

*All fathers and daughters will be provided with program resources including a t-shirt, and a Home activity handbook containing tasks for fathers and daughters to complete together at home (e.g., ‘Activators’ and ‘Skills Practice’). Participants will be advised to complete activities at least one ‘Activator’ and one ‘Skills Practice’ activity per week equating to a minimum approximate time investment of approximately 10 minutes per week. The program resources/activity handbook is designed specifically for this study.

Adherence to the intervention will be monitored by:
- Attendance records at the sessions
- Activities completed in the Handbook

For those fathers who sign up for the program in our local area (e.g., Newcastle, Maitland and Central Coast), their daughters will be invited to complete additional pre- and post-program measures, including basketball proficiency skills tests and a face-to-face interview administered questionnaire. We will recruit 30 daughters who have enrolled and consented to participate in this component of the study.
Intervention code [1] 320645 0
Lifestyle
Intervention code [2] 321562 0
Behaviour
Comparator / control treatment
The program will be evaluated using a non-randomized, prospective design without a control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327625 0
PRIMARY OUTCOME #1
1. Fidelity of the program delivery by facilitators during the fathers-only workshops and the daughters & dads sessions (including both education and practical components (e.g. rough and tumble play and handles, basketball skills and modified basketball games)). This will be measured by weekly post session reflections completed by the facilitators, which is validated by an independent observation by a member of the research team of at least two sessions per program. The reflection completed by facilitators and independent observation of sessions for validation is designed specifically for this study.
Timepoint [1] 327625 0
9-weeks post baseline (primary endpoint)
Primary outcome [2] 327626 0
PRIMARY OUTCOME #2
2. Attendance – as measured by percentage of Daughters & Dads Basketball sessions attended, Assessed using workshop attendance checklists at the fathers-only workshop and the father-and-daughter sessions on average across the eight weeks.
Timepoint [2] 327626 0
9-weeks post baseline (primary endpoint)
Primary outcome [3] 327627 0
PRIMARY OUTCOME #3
3. Compliance – as measured by the number of home tasks completed by Dads and their daughter. The activity handbooks will be collected after the final session by the University of Newcastle research team and the number of activities completed will be recorded.
Timepoint [3] 327627 0
9-weeks post baseline (primary endpoint)
Secondary outcome [1] 395981 0
PRIMARY OUTCOME #4
4. Satisfaction – Items measured via questionnaire using a 5-point Likert scale.
Timepoint [1] 395981 0
9-weeks post baseline (primary endpoint)
Secondary outcome [2] 395982 0
PRIMARY OUTCOME #5
5. Recruitment – achievement of recruitment targets for participants. Assessed by audit of study enrolment logs.
Timepoint [2] 395982 0
Baseline
Secondary outcome [3] 395983 0
Retention in basketball (completed by fathers)- assessed at 12-months post program using items developed for this study.
Timepoint [3] 395983 0
12-months post baseline
Secondary outcome [4] 395984 0
Daughters’ enjoyment in basketball - Adapted version of the Physical Activity Children’s Enjoyment Scale (via 16 items on a 5-point Likert Scale ranging from 1 = “disagree a lot” to 5 = “agree a lot” e.g., When I am at basketball training I enjoy it) (Moore et al., 2009). (completed by fathers and a sub-sample of 30 daughters)
Timepoint [4] 395984 0
Baseline, 9-weeks post baseline, 12-months post baseline (fathers only)
Secondary outcome [5] 395985 0
Intention to continue playing basketball - Intention to continue in basketball will be assessed using items developed for this study (“e.g., I'm interested in playing basketball after the program finishes in the backyard with my Dad”). (completed by fathers and a sub-sample of 30 daughters)
Timepoint [5] 395985 0
9-weeks post baseline
Secondary outcome [6] 395986 0
Test of basketball skill proficiency – Stationary bounce - Test of Gross Motor Development III (TGMD-3) (Ulrich, 2016). (completed by a sub-sample of 30 daughters)
Timepoint [6] 395986 0
Baseline, 9-weeks post baseline
Secondary outcome [7] 398919 0
Test of basketball skill proficiency – adapted free throw accuracy and success test based on the measure developed by Arias, 2012. (completed by a sub-sample of 30 daughters)
Timepoint [7] 398919 0
Baseline, 9-weeks post baseline
Secondary outcome [8] 398920 0
Test of basketball skill proficiency – Hot Spot 1 Minute Challenge - test developed by Basketball New South Wales (completed by a sub-sample of 30 daughters).
Timepoint [8] 398920 0
Baseline, 9-weeks post baseline
Secondary outcome [9] 398921 0
Test of basketball skill proficiency – adapted lay-up accuracy and success test based on the measure developed by Arias, 2012. (completed by a sub-sample of 30 daughters).
Timepoint [9] 398921 0
Baseline, 9-weeks post baseline
Secondary outcome [10] 400490 0
Test of basketball skill proficiency – Free throw qualitative assessment completed via video analysis using a marking criteria developed for this study (completed by a sub-sample of 30 daughters)
Timepoint [10] 400490 0
Baseline, 9-weeks post baseline
Secondary outcome [11] 400491 0
Test of basketball skill proficiency – Lay-up qualitative assessment completed via video analysis using a marking criteria developed for this study (completed by a sub-sample of 30 daughters)
Timepoint [11] 400491 0
Baseline, 9-weeks post baseline

Eligibility
Key inclusion criteria
Men can participate if they:
- Are a father or father-figure of a daughter

Aside from being aged 7-12 years, there are no additional eligibility criteria for daughters
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men with notable pre-existing health conditions (e.g., history of cardiovascular disease, recent chest pains while exercising) that do not have a doctor's clearance prior to enrolment will not be eligible,

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analyses (percentage and frequency counts) will be conducted to assess fidelity, compliance, recruitment, attendance, retention, and program satisfaction. For secondary outcomes, paired t-test will be used to compare mean scores at pre-intervention and post-intervention, and effect sizes calculated using Cohen d. Only participants who consent to be involved in research will be included in analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/10/2021
Actual
Date of last participant enrolment
Anticipated
18/10/2021
Actual
Date of last data collection
Anticipated
11/10/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308677 0
Government body
Name [1] 308677 0
NSW Office of Sport
Country [1] 308677 0
Australia
Funding source category [2] 308678 0
Charities/Societies/Foundations
Name [2] 308678 0
Basketball NSW
Country [2] 308678 0
Australia
Primary sponsor type
Individual
Name
Professor Philip Morgan
Address
Priority Research Centre for Physical Activity and Nutrition
School of Education
College of Human and Social Futures
University Drive
University of Newcastle
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 309556 0
None
Name [1] 309556 0
Address [1] 309556 0
Country [1] 309556 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308599 0
University of Newcastle's Human Research Ethics Committee
Ethics committee address [1] 308599 0
University of Newcastle Human Research Ethics Committee
University of Newcastle,
University Drive, Callaghan
NSW, 2308
Ethics committee country [1] 308599 0
Australia
Date submitted for ethics approval [1] 308599 0
20/08/2021
Approval date [1] 308599 0
Ethics approval number [1] 308599 0

Summary
Brief summary
The Daughters and Dads basketball Program is a sport-specific variant of the highly successful ‘Daughters And Dads Active and Empowered program’. Specifically, the program aims to engage fathers in positive lifestyle role modelling and effective parenting strategies to improve their daughters’ skill proficiency in basketball, basketball enjoyment and participation, and social-emotional wellbeing.

The purpose of this pre-post trial is to expand the evidence-base for Daughters and Dads Basketball from intervention testing to intervention replication (i.e., the first phase of translation research) using a quasi-experimental research design.

The present study will investigate whether:
a) Recruitment targets are achieved and program fidelity, compliance, satisfaction, and attendance is maintained,
b) The impact of Daughters & Dads Basketball on daughters’:
- Sport-specific skill proficiency (e.g., Basketball skills)
- Enjoyment in the sport (e.g., Basketball )
- Intention to continue playing the sport
- Long-term engagement in the sport
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 111282 0
Prof Philip Morgan
Address 111282 0
Priority Research Centre for Physical Activity and Nutrition
School of Education
College of Human and Social Futures
University Drive
University of Newcastle
Callaghan NSW 2308
Country 111282 0
Australia
Phone 111282 0
+61249217265
Fax 111282 0
Email 111282 0
[email protected]
Contact person for public queries
Name 111283 0
Prof Philip Morgan
Address 111283 0
Priority Research Centre for Physical Activity and Nutrition
School of Education
College of Human and Social Futures
University Drive
University of Newcastle
Callaghan NSW 2308
Country 111283 0
Australia
Phone 111283 0
+61249217265
Fax 111283 0
Email 111283 0
[email protected]
Contact person for scientific queries
Name 111284 0
Prof Philip Morgan
Address 111284 0
Priority Research Centre for Physical Activity and Nutrition
School of Education
College of Human and Social Futures
University Drive
University of Newcastle
Callaghan NSW 2308
Country 111284 0
Australia
Phone 111284 0
+61249217265
Fax 111284 0
Email 111284 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified individual participant data will not be available for this study


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.