Enjoy your baby, life skills for mums with new babies: a pilot randomised control trial

Completed

Conditions: ow mood/ postnatal depression
Mental and Behavioural Disorders

Registration Number: ISRCTN90927910

Lead Sponsor: niversity of Glasgow, College of Medical, Veterinary and Life Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 60

Inclusion Criteria

1. Women over the age of 18 with a child under 18 months (amended from: a child under one year old as of 31/03/2016)
2. Not currently accessing formal mental health services e.g. a psychologist/counselor
3. Score of 5 or more on the PHQ-9 (amended from: score of 10 or more on 31/03/2016)
4. Ability to read and understand English
5. Access to the internet and able to listen to audio recordings

Exclusion Criteria

1. Women under 18 years old without a child under the age of 18 months (amended from: child under the age of 1 on 31/03/2016)
2. Already engaged with formal mental health supports e.g. attending a CMHT
3. Cannot read or understand English
4. Does not have web access as the intervention is via the internet
5. Not presenting with symptoms of low mood- assessed by a score of less than 5 on the PHQ-9 (amended from: score of less than 10 as of 31/03/2016)
6. Women who report active suicidal ideation, identified by their response to question nine on the PHQ-9 (Thoughts that you would be better off dead or of hurting yourself in some way” either more than half the days” or nearly every day”) will be excluded and redirected to their GP to seek immediate access to mental health services.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the ability to recruit participants, deliver the online course and to gather evaluations.<br><br>Recruitment and engagement will be monitored from the study opening and throughout. Descriptive statistics will be used to describe the sample demographic details. An intention to treat protocol will be used when analysing the data obtained on the outcome measures. Descriptive statistics will be used to show how participants evaluate the intervention. A power calculation for future studies will be conducted at the end of the study and be informed by the take-up, follow-up and retention rates in the study, coupled with estimates of treatment effect gathered during the pilot phase.

Secondary Outcome Measures

Name	Time	Method
1. PHQ-9, a self-report measure of depressive symptoms<br>2. Generalized Anxiety Disorder-7 (GAD-7) a self-report measure of generalized anxiety<br>3. Edinburgh Postnatal Depression Scale (EPDS) a 10 question self-report measure designed for use with mothers of young babies<br><br>Timepoints as of 31/03/2016:<br>These will be administered at baseline and at eight week follow-up<br><br>Initial timepoints:<br>These will be administered at baseline, eight week follow-up and 12 week follow-up<br>