Condition category
Mental and Behavioural Disorders
Date applied
29/04/2020
Date assigned
06/05/2020
Last edited
06/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Parents who have adolescents with intellectual disability often have additional needs and higher levels of stress. Despite this, there are no current parenting programmes specifically designed for this population. The aim of this study is to test whether a Parents Plus programme designed for these parents improves their adolescents’ behavioural and emotional difficulties, improves their parenting and family adjustment and increases their parenting confidence and satisfaction. The researchers also hope to test whether it helps parents achieve the goals they have for themselves and their adolescent.

Who can participate?
Parents who have an adolescent with an intellectual disability who are linked in with participating Irish disability services

What does the study involve?
The study involves completing questionnaires on three different occasions and taking part in an eight-week parenting programme. Participants may be asked to complete the questionnaires twice before they do the programme, and once afterwards, or once before and twice afterwards.

What are the possible benefits and risks of participating?
The benefit of taking part is that parents may learn new skills and meet other parents who can help them meet their goals for their child and family. The risk is that this will not happen. There are no additional risks for completing the questionnaires, but it will take up some time.

Where is the study run from?
The study is being co-ordinated by Parents Plus and the School of Psychology, Trinity College Dublin (Ireland)

When is the study starting and how long is it expected to run for?
September 2018 to September 2020

Who is funding the study?
Parents Plus (Ireland)

Who is the main contact?
1. John Sharry
John@parentsplus.ie
2. Charlotte Wilson
cewilson@tcd.ie

Trial website

Contact information

Type

Public

Primary contact

Dr John Sharry

ORCID ID

Contact details

Parents Plus
Mater Hospital
Eccles Street
Dublin
D07 R2WY
Ireland
+353 (0)1 854 5185
john@parentsplus.ie

Type

Scientific

Additional contact

Dr Charlotte Wilson

ORCID ID

http://orcid.org/0000-0002-0800-153X

Contact details

School of Psychology
Aras an Phiarsaigh
Trinity College Dublin
Dublin
D02 PD91
Ireland
+353 (0)1 896 3237
cewilson@tcd.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Parents Plus Pathways programme: a pragmatic randomised controlled trial

Acronym

Study hypothesis

The Parents Plus Pathways Programme will positively impact parenting behaviour, adolescent behaviour, parenting satisfaction and confidence, and parents will meet their personally set goals compared to a waitlist control group.

Ethics approval

Approved 10/06/2019, Trinity College Dublin School of Psychology ethics committee (School of Psychology, Trinity College Dublin, Dublin 2, Ireland; +353 (0)1 896 3907; psycheth@tcd.ie), ref: SPREC042019-01

Study design

Wait-list randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Behavioural and emotional difficulties

Intervention

Wait-list randomised controlled trial with a 3-month follow-up period for the intervention group. Disability services that registered to complete the training in the intervention were randomised to an immediate intervention group and a waitlist control group. No masking or blinding was possible. The randomisation was completed by a researcher who had no knowledge of the services involved. The study was facilitated centrally through Parents Plus and Trinity College Dublin, but the intervention took place in 24 different sites.

The intervention being tested is the Parents Plus Pathways Programme for parents of adolescents with intellectual or developmental disabilities. This is an 8-week group programme. It covers strategies for managing behaviour in adolescents with intellectual and developmental disabilities through positive parenting strategies, and strategies for managing being a parent in that context. Each group session is 1.5 hours long and covers a strategy for managing adolescent behaviour and a strategy for managing as a parent.

The control group was a waitlist group who were offered the group after the intervention group programme ended.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Problem behaviours, prosocial behaviours, and emotional difficulties measured using the CAPES (Child Adjustment and Parental Efficacy Scale)
2. Parenting behaviours and family adjustment measured using the PAFAS (Parent and Family Adjustment Scale)

Measured at pre-intervention, post-intervention and 3-month follow up for intervention group, and at baseline and two months later (pre-intervention) and two months following this (post-intervention) for waitlist-control group

Secondary outcome measures

1. Parental self-efficacy measured using the CAPES
2. Parental satisfaction measured using the Kansas Satisfaction Scale
3. Parent goals for self and parent goals for child measured using the Parents Plus goal setting procedure

Measured at pre-intervention, post-intervention and 3 month follow up for intervention group, and at baseline and 2 months later (pre-intervention) and 2 months following this (post-intervention) for waitlist-control group.

Overall trial start date

01/09/2018

Overall trial end date

01/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

There were two types of inclusion criteria. Parents who were eligible to take part were determined by each service. The researchers instructed services that the programme was for parents of adolescents with intellectual or developmental disabilities. However, as it was a pragmatic trial they left it up to services to determine individual eligibility. They would suggest that it was:
1. A parent of an adolescent (aged 12-20) with an intellectual or developmental disability
2. A parent who is willing and able to attend 8 group sessions

Service inclusion criteria included:
1. A service whose clients were children, adolescents and/or young adults with intellectual disabilities and/or developmental disabilities
2. A service who had two practitioners who could attend training
3. A service who was willing to take part in the evaluation and request and collect data from parents

Participant type

Carer

Age group

Adult

Gender

Both

Target number of participants

24 services expressed an interest. Each service was required to run one group. Each group was ideally between 5 and 12 participants. This would lead to a sample size of between 120 and 288. This was sufficient to find a small effect size.

Participant exclusion criteria

There were no official exclusion criteria. Each service was requested to invite suitable participants and therefore the exclusion criteria were left up to individual services.

Recruitment start date

18/06/2019

Recruitment end date

20/01/2020

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Brothers of Charity, Galway
Woodlands Centre, Renmore
Galway
H91 KN20
Ireland

Trial participating centre

Brothers of Charity, Ballincollig
Positive Behavioural Support Services Chapel Gate Ballincollig
Cork
P31 EP26
Ireland

Trial participating centre

West Cork Child Development Service
St Mary's Road, Dunmanway
Cork
P47 PD89
Ireland

Trial participating centre

St Paul's Special School, Beaumont
Beaumont Woods, Beaumont Dublin 9
Dublin
D09 VY30
Ireland

Trial participating centre

Down Syndrome Ireland, Ballymount
Unit 3, Park Way House Western Parkway Business Park Ballymount Drive, Dublin 12
Dublin
D12 HP70
Ireland

Trial participating centre

Down Syndrome Centre, Cabinteely
Shrewsbury House Old Bray Road Cabinteely Dublin 18
Dublin
D18 KX60
Ireland

Trial participating centre

CAMHS ID
Skehard Road
Cork
T12 YR2P
Ireland

Trial participating centre

Treetops Children's Services
Cork Street Dublin 8
Dublin
D08 DH31
Ireland

Trial participating centre

Daughters of Charity
23 Ashtown Road Navan Road Dublin 7
Dublin
D07 E4EK
Ireland

Trial participating centre

Cheeverstown House
Templelogue Road Dublin 6
Dublin
D6W TX36
Ireland

Trial participating centre

South Kildare Network Disability Team
Cill Dara Primary Healthcare Campus Curragh Road
Kildare
R51 RX51
Ireland

Trial participating centre

School Age Disability Team
Rossecourt Resource Centre Balgaddy Lucan
Co Dublin
K78 R9C9
Ireland

Trial participating centre

Child Development Team
Bailis Resource Centre Johnstown Co. Meath
Navan
C15 W303
Ireland

Trial participating centre

COPE Foundation
Bonnington Middle Glanmire Road Montenotte
Cork
T23 PT93
Ireland

Trial participating centre

Ability West
Blackrock House Dún Na Carraige Blackrock Salthill
Galway
H91 R254
Ireland

Trial participating centre

Scoil Chiaráin Special School
Saint Canice's Road Dublin 11
Dublin
D11 VK64
Ireland

Trial participating centre

Stewarts Care
Mill Lane Palmerstown Dublin 20
Dublin
D20 DV79
Ireland

Trial participating centre

Children's Services Centre,
Kilcreene Hospital Complex Ballycallan Road
Kilkenny
R95 DK07
Ireland

Trial participating centre

Beechpark Disability Service
Beechpark Service Bryan S. Ryan Building Main Road Tallaght
Dublin
D24 HH7F
Ireland

Trial participating centre

Children's Early Intervention Service
Northern Health & Social Care Trust Headquarters Bretten Hall Bush Road Antrim
Belfast
BT41 2RL
United Kingdom

Trial participating centre

West Limerick Children's Services
28 Oak Park Newcastle West
Limerick
V42 E248
Ireland

Trial participating centre

Letterkenny Youth and Family Service
New Line House Glencar
Letterkenny
F92 CDC0
Ireland

Trial participating centre

Donegal Down Syndrome Centre
4 Garda Terrace High Road
Letterkenny
F92 TX3X
Ireland

Sponsor information

Organisation

Parents Plus

Sponsor details

Mater Hospital
Eccles Street
Dublin
D07 R2WY
Ireland
+353 (0)1 854 5185
info@parentsplus.ie

Sponsor type

Charity

Website

https://www.parentsplus.ie

Funders

Funder type

Charity

Funder name

Parents Plus

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers intend to submit a paper with the main results in May 2020. They intend to publish final results (including the impact of the intervention on the waitlist control group in Autumn 2020.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Charlotte Wilson (cewilson@tcd.ie). Data files with fully anonymised data, both raw data and subscales for each measure (CAPES, PAFAS, KSS, Goals) along with some basic demographic data (age of child and parent, gender of child and parent, number of children with disabilities in the family, diagnoses) will be available from Summer 2021 for at least 10 years (indefinitely if it is possible to formally archive). Data will be made available to researchers who have ethical approval to conduct studies that are in line with the original aims of the study. Consent from participants has been given for this, and none of the data will be identifiable.

Intention to publish date

11/05/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/05/2020: Trial's existence confirmed by Trinity College Dublin School of Psychology ethics committee.