Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202405833441169 Date of Approval: 03/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title An adapted brief intervention with perinatal mothers misusing substances: A randomised feasibility pilot study in task-sharing at Mowbray Maternity Hospital
Official scientific title An adapted brief intervention with perinatal mothers misusing substances: A randomised feasibility pilot study in task-sharing at Mowbray Maternity Hospital
Brief summary describing the background and objectives of the trial Mowbray maternity hospital has been identified as an institution with a dire need for intervention with pregnant and post-partum mothers who use substances and may have a substance use disorder (SUD). The population of mothers in this hospital is likely reflective of many communities in South Africa. In a preliminary qualitative study, the perspectives of perinatal moms and healthcare workers at Mowbray Maternity Hospital (MMH) was used to adapt an existing evidence-based intervention (Motivational Interviewing plus Activation and Commitment Therapy – MIACT). The purpose of this pilot study is to determine the preliminary feasibility, acceptability, and efficacy of a locally adapted brief task-shared intervention (Relapse Prevention-oriented MIACT – RP-MIACT) with this vulnerable population to establish effectiveness in reducing substance use and improving associated health outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychological intervention for mental/behavioural disorder.
Anticipated trial start date 02/09/2024
Actual trial start date
Anticipated date of last follow up 03/03/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL n/a
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Relapse Prevention Oriented Motivational Interviewing plus Activation and Commitment Therapy RPMIACT Four weekly individual sessions of approximately 50 minutes per session. Over a 4-week period. MIACT was developed as a hospital-initiated intervention combining principles of MI and ACT (Stotts et al., 2022). MIACT is a 3-session individual intervention aimed at increasing motivation to address behaviour change and introducing mindfulness and acceptance skills to assist mothers in managing harmful thinking patterns and behaviour. In their study, a reduction in substance use was seen as a secondary outcome with maternal obstetric health as a primary focus. In a preliminary qualitative study, the perspectives of perinatal moms and healthcare workers at MMH was used to adapt MIACT. Based on participant feedback to incorporate more practical skills training the adapted intervention includes more skills-based techniques such as problem-solving, emotion regulation and distress tolerance with a greater focus on relapse prevention therefore referring to the newly adapted intervention as Relapse Prevention-oriented MIACT (RP-MIACT). 25
Control Group Conventional Care How much and how often the patient receives conventional care will be determined by hospital staff treating the patient. Treatment will be monitored over a 4-month period (from baseline to 3-month follow-up assessment). Conventional care consists of routine visits to MMH where treatment is determined by hospital staff. 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Currently attending routine visits at Mowbray Maternity Hospital (MMH) • 18 ≥ years of age. • Able to attend seven sessions (3 assessment sessions plus four intervention sessions). • Self-reported verbal fluency in English or Afrikaans. • ≤ 18 years of age. • Unable to communicate fluently in English or Afrikaans. • Currently receiving treatment (psychological/pharmacological) for SUD. • Have a diagnosis or meet criteria for bipolar disorder, suicidality, homicidality, schizophrenia (including current and/or history of psychosis), cognitive or intellectual impairment and antisocial personality disorder. Adult: 19 Year-44 Year 18 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/05/2024 University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Barnard Fuller, Anzio Road, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is to establish effectiveness in reducing substance use amongst perinatal mothers who misuse substances. baseline, 6 weeks and 3 months
Secondary Outcome The secondary outcome is to establish the effectiveness of improving associated health outcomes amongst perinatal mothers who misuse substances. baseline, 6 weeks and 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mowbray Maternity Hospital 12 Hornsey Rd, Mowbray Cape Town 7700 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
na n/a na South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor na n/a na South Africa n/a
COLLABORATORS
Name Street address City Postal code Country
Dan Stein Observatory Cape Town 7925 South Africa
Goodman Sibeko Observatory Cape Town 7925 South Africa
Kyle Young Observatory Cape Town 7925 South Africa
Bronwyn Myers Franchi Curtin Perth 6845 Australia
Jessica Wang Wilshire Boulevard Los Angeles 90024 United States of America
Steven Shoptaw Wilshire Boulevard Los Angeles 90024 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Amy Sabrina Adams amy.adams@uct.ac.za +27798877322 Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Snr Lecturer UCT
Role Name Email Phone Street address
Principal Investigator Amy Sabrina Adams amy.adams@uct.ac.za +27798877322 Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Snr Lecturer UCT
Role Name Email Phone Street address
Scientific Enquiries Amy Sabrina Adams amy.adams@uct.ac.za +27798877322 Anzio Road
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Snr Lecturer UCT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices). Informed Consent Form After the completion of the data collection process which may be between 4 to 9 months. Controlled access only will be permitted. All requests for data analyses, requests for data and documents must be made to the PI.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information