AADAPT Online – Addressing young mums’ and dads’ low mood and their parenting
| ISRCTN | ISRCTN14608187 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14608187 |
| IRAS number | 347818 |
- Submission date
- 20/11/2023
- Registration date
- 22/11/2023
- Last edited
- 25/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Depression is a common mental health difficulty that often starts in adolescence. Becoming a parent during adolescence presents additional challenges and parental mental health problems can impact how parents interact with their children. Not only does depression directly effect the young parents themselves but it has also been shown to impact on parenting and parent-child interactions.
A therapy called Behavioural Activation (BA) has been shown to help people deal with negative thoughts and feelings and is widely used in the NHS. This study aims to see whether an Online BA package of information and activities, supported by trained volunteer parents who were previously young parents themselves (Parent Buddies) is acceptable and helpful to young parents and to measure parents’ level of engagement with the Online BA package. Parents in the Online BA group will also receive information and ideas for different activities to help them engage in sensitive, positive interactions with their infant. The Online BA package targets both depression and parenting. Parents will be allocated to either AADAPT Online or AADAPT Self-Guided and this will be decided at random by a computer.
AADAPT Online: Parents will be given access to six online BA sessions accompanied by an initial introductory call and then six weekly conversations with a Parent Buddy. Parent Buddies can direct parents to additional content with the aim of supporting parents with the core concepts.
AADAPT Self-Guided (control arm): Parents will be given access to the BA sessions via email and or in the post, 12 weeks after being allocated to this group. They can work through these at their own pace. They will not be supported by a Parent Buddy volunteer.
Who can participate?
Parents aged 16 -24 years old with depression and low mood and a baby 12 months or younger at the start of the study.
What does the study involve?
Young Parents: When a parent agrees to take part in the study they will be asked to fill out some questionnaires about their mood, stress, perceived support and some questions about their lifestyle and family set-up. If they agree, they will also be given HeadCams to record some video footage of them playing with their baby at home. After 12 weeks all parents will be asked to complete these questionnaires again and take some more videos of them playing with their baby if they want to. After this parents in the AADAPT Self-Guided group will be sent the AADAPT BA materials.
Parent Buddies: Will receive training from the research team about how to support parents through the BA online activities and materials. Their main role is to help parents access AADAPT online and work through the activities. They will have regular supervision sessions with the research team.
All parents and Buddies will be asked to take part in an additional interview at the end of the study to talk about their experiences of being part of AADAPT.
What are the possible benefits and risks of participating?
The results from the study will help us see if the online BA materials with peer support are helpful for young parents with low mood. All parents taking part in AADAPT will be given access to the BA support materials regardless of the group they are in. Parents will also have the option to receive images and video clips of them playing with their baby.
Some of the questionnaires and talking about being a young parent and feeling low in mood may bring up sensitive or difficult thoughts and feelings. The questionnaires have been used in previous research studies and other young parents have checked to make sure the questions are acceptable.
Parent Buddy volunteers will be able to develop their own skills to become an effective peer mentor through the training. They will also be helping us to see if the BA online materials with peer support are helpful for young parents with low mood. The study will involve talking to other young parents who are experiencing low mood. This may bring up sensitive or difficult memories, thoughts and feelings. They will receive ongoing support from the research team.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
May 2022 to December 2025
Who is funding the study?
The Prudence Trust (UK)
Who is the main contact?
Emma Brooks, emma.brooks@psych.ox.ac.uk
Contact information
Public
Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
| Phone | +44 (0)1865618330 |
|---|---|
| emma.brooks@psych.ox.ac.uk |
Scientific, Principal Investigator
Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
| Phone | +44 (0)1865618330 |
|---|---|
| louise.dalton@psych.ox.ac.uk |
Study information
| Study design | Interventional pilot two-arm randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Internet/virtual, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | An online behavioural activation & parenting self-help package supported by peer mentors (AADAPT Online) for 16-24-year-old parents experiencing depression: a pilot randomised control trial |
| Study acronym | AADAPT |
| Study hypothesis | Current study hypothesis as of 19/06/2024: The aim of the AADAPT study is to compare if an online Behavioural Activation/Parenting self-help package supported by peer mentors (referred to as Parent Buddies), is feasible and acceptable for 16-24-year-old parents experiencing low mood, and to see if it improves parental mental health and parent-child interactions. Previous study hypothesis: The aim of the AADAPT study is to compare if an online Behavioural Activation/Parenting self-help package supported by peer mentors (referred to as Parent Buddies), is more effective compared to waitlist control in improving parental mental health and parent-child interactions in 16-24-year-old parents experiencing low mood. |
| Ethics approval(s) |
1. Approved 14/11/2023, Medical Sciences Interdivisional Research Ethics Committee (MS IDREC) (Research Services, Boundary Brook House, Churchill Drive, Headington, Oxford, OX3 7GB, United Kingdom; +44 (0)1865 616575; ethics@medsci.ox.ac.uk), ref: R88863/RE001 2. Approved 19/12/2024, Wales Research Ethics Committee 3 (Health And Care Research Wales, Castlebridge, 5-19 Cowbridge Road, Cardiff, CF11 9AB, United Kingdom; +44 (0)2920 230457; HCRW.approvals@wales.nhs.uk), ref: 24/WA/0366 |
| Condition | Depression in parents aged 16-24 years |
| Intervention | Current interventions as of 09/01/2024: Participants will be randomised in a 1:1 ratio to (i) AADAPT Online Intervention or (ii) AADAPT Self-Guided (waitlist control). Randomisation will be minimised by severity of depression (EPDS scores <=12; >=13) and the age of the parent (<=20; >=21). Participants will be randomised using a secured web-based called Trial Deck that will automatically occur after the participating parent completes the consent and baseline measures. Intervention(s): Online psychological intervention for parents with depression supported by peer mentors (AADAPT Online). AADAPT Online is a behavioural activation and parenting self-help package supported by peer mentor volunteers (referred to as Parent Buddies). The six modules are completed by the adolescent parent over six weeks. Parent Buddies will conduct an initial introductory call with the parent followed by weekly 15-20 minute conversations (either via messaging or audio/video call) to provide support to the adolescent parent. Comparator: Waitlist control group who receive the AADAPT Online materials (but no support from peer mentor volunteers) via email or post after their follow-up assessment. For both arms (intervention and wait list), there is a follow-up assessment 12 weeks after randomisation. Study information will be available online. After eligibility screening which involves questions online and a brief phone call with the research team, participants will be automatically randomised to receive either AADAPT Online or to the wait-list control after consenting online and completing some baseline measures. Treatment allocation will be communicated to participants online. _____ Previous interventions: Participants will be randomised in a 1:1 ratio to (i) AADAPT Online Intervention or (ii) AADAPT Self-Guided (waitlist control). Randomisation will be minimised by severity of depression (EPDS scores <=13; >=14) and the age of the parent (<=20; >=21). Participants will be randomised using a secured web-based called Trial Deck that will automatically occur after the participating parent completes the consent and baseline measures. Intervention(s): Online psychological intervention for parents with depression supported by peer mentors (AADAPT Online). AADAPT Online is a behavioural activation and parenting self-help package supported by peer mentors (referred to as Parent Buddies). The seven modules are completed by the parent over 7 weeks supported by weekly 15-20 minute conversations (either via messaging or audio/video call) between the adolescent parent and the Parent Buddy. Comparator: Waitlist control group who receive the AADAPT Online materials (but no support from peer mentors) via email or post after their follow-up assessment. For both arms (intervention and wait list), there is a follow-up assessment 12 weeks after randomisation. Study information will be available online. After eligibility screening which involves questions online and a brief phone call with the research team, participants will be automatically randomised to receive either AADAPT Online or to the wait-list control after consenting online and completing some baseline measures. Treatment allocation will be communicated to participants online. |
| Intervention type | Behavioural |
| Primary outcome measure | Current co-primary outcome measures as of 19/06/2024: 1. To assess the feasibility of recruitment and intervention methods, including the number of young parents screened, the percentage of those who were eligible at screening who were recruited, and the percentage of those recruited who completed the follow-up assessment – measure using data collected by the AADAPT online throughout the study 2. Measure treatment adherence and acceptability of AADAPT Online, including the number of young parents who completed treatment (defined as 4 out of 6 sessions) measure using data collected by the AADAPT online throughout the study Previous primary outcome measure: Parental depression is measured using parent self-report questionnaire (Edinburgh Postnatal Depression Scale, EPDS) at baseline and 12 weeks post randomisation |
| Secondary outcome measures | Current secondary outcome measures as of 19/06/2024: 1. Parental depression measured using a parent self-report questionnaire (Edinburgh Postnatal Depression Scale, EPDS) at baseline and 12 weeks post-randomisation 2. Parent-infant interactions measured using simultaneous Headcam footage from parent and infant collected at baseline and 12 weeks post-randomisation 3. Parental stress measured using a parent self-report questionnaire (Parenting Stress Index, PSI-4-SF) at baseline and 12 weeks post-randomisation 4. Parental mental health measured using a self-reported General Health Questionnaire (GHQ-12) at baseline and 12 weeks post-randomisation 5. Perceived social support measured using parent self-report (Multiple Dimension Scale of Perceived Social Support, MSPSS) at baseline and 12 weeks post-randomisation 6. Health economic outcome measured using self-report European Quality of Life 5 Dimensions (EQ-5D-5L), Recovering Quality of Life (Re-QoL) and subsections 4.1, 4.2, 4.3 and 4.4, section 5 of Client Service Receipt Inventory (CSRI) at baseline and 12 weeks post-randomisation 7. Treatment adherence and engagement with AADAPT Online, including the number of modules viewed, the number of successful contact attempts by Parent Buddy compared to unsuccessful contact attempts, the number of times logged in, the total amount of time spent in AADAPT Online and the number of exercises completed in AADAPT Online measured using data collected by AADAPT online and study records throughout the study 8. Assessment of recruitment and retention of Parent Buddies, including the number of Parent Buddies invited for training, percentage of those who completed training, percentage of those who actively support Mentees after training, the number of Mentees supported by each Parent Buddy, length of time Parent Buddies remain with the programme measured using study records throughout the study 9. Qualitative outcomes of the AADAPT intervention, measured using data collected from semi-structured interviews after 12 weeks post-randomisation Previous secondary outcome measures as of 09/01/2024: 1. Parent-infant interactions assessed from simultaneous Headcam footage from parent and infant collected at baseline and 12 weeks post-randomisation 2. Parental stress measured using parent self-report questionnaire (Parenting Stress Index, PSI-4-SF) at baseline and 12 weeks post-randomisation 3. Parental mental health will be assessed using self-reported General Health Questionnaire (GHQ-12) at baseline and 12 weeks post-randomisation 3. Perceived social support measured using parent self-report (Multiple Dimension Scale of Perceived Social Support, MSPSS) at baseline and 12 weeks post-randomisation 4. Health economic outcome measures using self-report European Quality of Life 5 Dimensions (EQ-5D-5L), Recovering Quality of Life (Re-QoL) and subsections 4.1, 4.2, 4.3 and 4.4, section 5 of Client Service Receipt Inventory (CSRI) at baseline and 12 weeks post-randomisation 5. Qualitative outcomes of the AADAPT intervention, collected in the format of semi-structured interviews after 12 weeks post-randomisation _____ Previous secondary outcome measures: 1. Parent-infant interactions assessed from simultaneous Headcam footage from parent and infant collected at baseline and 12 weeks post-randomisation 2. Parental stress measured using parent self-report questionnaire (Parenting Stress Index, PSI-4-SF) at baseline and 12 weeks post-randomisation 3. Perceived social support measured using parent self-report (Multiple Dimension Scale of Perceived Social Support, MSPSS) at baseline and 12 weeks post-randomisation 4. Health economic outcome measures using self-report European Quality of Life 5 Dimensions (EQ-5D-5L), Recovering Quality of Life (Re-QoL) and subsections 4.1, 4.2, 4.3 and 4.4, section 5 of Client Service Receipt Inventory (CSRI) at baseline and 12 weeks post-randomisation 5. Qualitative outcomes of the AADAPT intervention, collected in the format of semi-structured interviews after 12 weeks post-randomisation |
| Overall study start date | 01/05/2022 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 24 Years |
| Sex | Both |
| Target number of participants | 60 adolescent parents (30 in each arm) |
| Participant inclusion criteria | Current inclusion criteria as of 09/01/2024: Adolescent Parent: 1. Aged 16-24 years 2. Child born within 12 months at the time of recruitment 3. Score 10 or above on EPDS 4. Lives in the UK 5. Able to provide free informed consent to participate 6. Sufficient understanding of English (secondary school level, age 11) reading ability as the self-help package requires participants to read and understand the documents and suggested activities _____ Previous inclusion criteria: Adolescent Parent: 1. Aged 16-24 years 2. Child born within 12 months at the time of recruitment 3. Score 10 or above on EPDS 4. Lives in the UK 5. Able to provide free informed consent to participate 6. Sufficient understanding of English (secondary school level, age 11) reading ability as the self-help package requires participants to read and understand the documents and suggested activities Peer Mentors (Parent Buddies): 1. Aged 25-35 years 2. Had first baby when they were under 25 years old 3. Have had experience of low mood (defined as feeling low, down, depressed or stressed most days for 2 or more weeks) 4. Lives in the UK 5. Able to provide free informed consent to participate 6. Sufficient understanding of English (secondary school level, age 11) reading ability as they will be helping parents navigate the self-help package |
| Participant exclusion criteria | Current exclusion criteria as of 09/01/2024: Adolescent parents: 1. Aged under 16 or over 25 years 2. Not a parent 3. Child older than 12 months at time of recruitment 4. Co-habiting partner already randomised into the study 5. Score of less than 10 on EPDS 6. Active suicidality 7. Active symptoms of psychosis or mania as part of bi-polar disorder 8. Currently receiving psychological treatment 9. Lives outside the UK 10. Unable to consent to participate 11. Insufficient understanding of English _____ Previous exclusion criteria: Adolescent parents: 1. Aged under 16 or over 25 years 2. Not a parent 3. Child older than 12 months at time of recruitment 4. Co-habiting partner already randomised into the study 5. Score of less than 10 on EPDS 6. Active suicidality 7. Active symptoms of psychosis or mania as part of bi-polar disorder 8. Currently receiving psychological treatment 9. Lives outside the UK 10. Unable to consent to participate 11. Insufficient understanding of English Peer Mentors: 1. Aged under 25 years or over 35 years 2. Not a parent 3. Had first baby when they were aged 25 years or older 4. No experience of low mood (defined as feeling low, down, depressed or stressed most days for 2 or more weeks) 5. Lives outside of UK 6. Current mental health or emotional difficulties that preclude capacity to be an appropriate peer mentor to another person who has mental health difficulties 7. Unable to consent to participate 8. Insufficient understanding of English |
| Recruitment start date | 01/06/2024 |
| Recruitment end date | 30/09/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
Sponsor information
University/education
Research Services
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 61675 |
|---|---|
| ethics@medsci.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Prudence Trust
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results will be published in peer-reviewed scientific journals with open access. A summary of the findings will be circulated at the end of the study to all participants. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 06/06/2024 | 04/07/2024 | No | No |
| Protocol file | version 1.1 | 18/12/2024 | 10/01/2025 | No | No |
| Protocol file | version 1.2 | 17/04/2025 | 25/04/2025 | No | No |
Additional files
Editorial Notes
25/04/2025: The following changes were made:
1. The overall study end date was changed from 29/08/2025 to 31/12/2025.
2. The recruitment end date was changed from 31/05/2025 to 30/09/2025.
3. The protocol (not peer reviewed) version 1.2 was uploaded.
10/01/2025: For context, the study was originally granted favourable ethical approval by the University of Oxford MS IDREC on 14/11/2023 to recruit participants through community settings. However, to further support recruitment to the study NHS REC/HRA approval was applied for to additionally recruit through NHS services which was approved on 19/12/2024 (IRAS ID 347818, Ethics Ref: 24/WA/0366). The trial registry retains the original overall study start date and recruitment start date as specified in the University of Oxford MS IDREC approval. However, as it is not possible to backdate these study milestones in the NHS REC application, the study start dates and recruitment dates in protocol V1.1 reflect more recent dates that needed to be entered to submit the IRAS application for NHS REC approval.
The following changes were made:
1. NHS REC/HRA approval was added.
2. The overall study end date was changed from 30/06/2025 to 29/08/2025.
3. The recruitment end date was changed from 31/03/2025 to 31/05/2025.
4. Protocol V1.1 (not peer-reviewed) was uploaded.
5. IRAS number added.
04/07/2024: Uploaded protocol (not peer-reviewed) as an additional file.
19/06/2024: The following changes were made:
1. The study hypothesis was changed.
2. The overall study end date was changed from 31/01/2025 to 30/06/2025.
3. The primary outcome measures were changed.
4. The secondary outcome measures were changed.
5. The recruitment start date was changed from 27/11/2023 to 01/06/2024.
6. The recruitment end date was changed from 30/08/2024 to 31/03/2025
7. The plain English summary was updated to reflect these changes.
09/01/2024: The following changes were made to the trial record:
1. The interventions were changed.
2. The secondary outcome measures were changed.
3. The inclusion criteria were changed.
4. The target number of participants was changed from "60 adolescent parents (30 in each arm). Approximately 20 peer mentors" to "60 adolescent parents (30 in each arm)."
5. The exclusion criteria were changed.
6. The plain English summary was updated to reflect these changes.
21/11/2023: Study's existence confirmed by the Medical Sciences Interdivisional Research Ethics Committee (MS IDREC).
