Parental substance misuse and its effects on children and families Mental and Behavioural Disorders Parental substance misuse and its effects on children and families
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Fathers who meet ICD-10 diagnostic criteria for opioid dependence who are prescribed opioid substitution therapy e.g. methadone, buprenorphine 2. Fathers with opioid dependence who also use other types of psychoactive substances (e.g. benzodiazepine, cocaine, cannabis or alcohol) are eligible for inclusion in this study, in recognition that poly-drug use is the norm 3. Mothers/partners of fathers recruited into the study are eligible to take part whether or not they have a diagnosis of substance dependence themselves 4. Each family will have at least one ‘index’ child aged 0-5 years old 5. Target children included in the study can be biological or non-biological children of the included father 6. Fathers must be involved in the day-to-day care of the index child 7. Fathers must have been in a relationship with the mother/partner for at least 6 months
Exclusion criteria
Exclusion criteria: 1. Either parent has a serious mental illness (e.g. active psychosis) which prevents them from fully participating in the programme 2. Families where domestic abuse or child abuse has resulted in the father being prohibited from contact with the target child or family 3. Families where the father is facing an imminent prison sentence of longer than 6 months, or a criminal justice order of longer than 6 months which would prohibit their active involvement in the programme 4. Either parent is under the age of 16 years and/or NOT officially resident in Lothian region
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As this is a feasibility study, the main study outcome is whether the study meets pre-set progression criteria. However, the study will also test a range of outcome measures for acceptability and sensitivity to change for use in a subsequent trial. Feasibility outcomes: 1. Recruitment rate, recorded as the number of eligible families who consent to participate in the study by 12 months 2. Retention rates, recorded as the number of eligible families who complete the parenting programme and the number of families that remain in the study until the follow-up at 6 months 3. Acceptability of the intervention, assessed by parent (on completion or drop out of the programme), practitioner and referrer feedback (over the 12 month implementation phase), including analysis of barriers/facilitators to recruitment and retention 4. Successful implementation of the intervention in non-NHS settings, measured by the number of PuP practitioners trained to accreditation level who are retained in each delivery site, and continuing provision of the intervention in both delivery sites by the end of the study 5. Fidelity of intervention delivery, measured by a parent-reported bespoke PuP fidelity measure (on completion or drop out of the programme) 6. Acceptability and appropriateness of all outcome measures, measured by questionnaire completion rates and rates of missing data per questionnaire (at baseline, end-of-treatment, and 6 month follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome measures for the family are assessed at baseline (pre-intervention), end-of-treatment (post-intervention) and at 6 months follow-up: 1. Child behaviour, measured by father and mother reported SDQ and BITSEA 2. Child protection outcomes, measured by father and mother reported B-CAPI and child protection 'at-risk' registrations, de-registrations and out-of-home placements (retrospective continuous data obtained from Social Work Scotland records at 6 month follow-up) 3. Quality of caregiving, measured by the Emotional Availability Scales (EAS) 4. Parenting knowledge, skills and competence, measured by the Parenting Sense of Competence Scale (PSCS) 5. Parental affect regulation, measured by the Difficulties in Emotion Regulation Scale (DERS) 6. Couple relationship functioning, measured by the Revised Conflict Tactics Scale (CTS2) 7. Substance use, measured by the Treatment Outcome Profile (TOP) and prescribed opioid substitution therapy (OST) daily dose (retrospective continuous data obtained from prescribing records at 6 month follow-up) 8. Health utility, measured by the EQ-5D-5L 9. Acceptability of health economics measures, assessed by father and mother feedback (via qualitative data at end-of treatment interview) and completion rates of service use questionnaires 10. Clinically significant change in outcomes for individual families, measured using the Reliable Change Index. This will determine whether there has been a reliable improvement in each of the key domains for both fathers and mothers on: DERS, EAS and B-CAPI (from baseline to end-of-treatment and 6 month follow-up) | — |
Countries
Scotland, United Kingdom